Validation Specialist Resume Sample
Kristin West
1437 Mertz Crossroad,
San Francisco,
CA
+1 (555) 755 2742
Work Experience
Validation Specialist
12/2016
-
PRESENT
San Francisco, CA
- 3 – 5 year’s work experience in related validation experience
- Manage the site change control program to ensure changes are processed in alignment with the local SOP
- Ensure manufacturing processes and cleaning procedures are properly validated and maintained in a validated state in alignment with the local SOP
- Ensure manufacturing equipment and process utilities and water treatment systems are properly qualified for their intended use in alignment with the local SOP
- Support regulatory and customer audits as required supporting validation and change control reviews
- Ensure the site Master Validation Plan is written and kept up to date
- Ensure a local Change Control SOP is written, is consistent with Lonza GROUP procedures, and is kept up to date
- Establish a document storage program for change control related documents to allow for complete and rapid retrieval when requested
Computer Validation Specialist
04/2014
-
09/2016
Phoenix, AZ
- Esure a local validation SOP is written, is consistent with Lonza GROUP procedures, and is kept up to date
- Establish a document storage program for validation related documents to allow for complete and rapid retrieval when requested
- Create, perform, review and finalize Installation, Operational and Performance qualification of equipment protocols associated with manufacturing process, quality control, and analytical development activities
- Interface with clients and project team members from Engineering, Quality, and Manufacturing to ensure that the design, implementation, and qualification of equipment, systems, and processes is conducted according to established quality standards through lifecycle management
- Deliver best in class quality, efficient and cost-effective validation services to our clients
- Provide validation support for facility, utilities, cleaning, and process
- Generate / execute validation protocols and reports, including gap analysis of existing protocols against industry standards
- Create, review, edit, and approve validation documents in conjunction with the functional groups
- Provide guidance for the quality/technical review of records for compliance to cGMP and client’s internal SOPs
Software Validation Specialist
11/2010
-
01/2014
Houston, TX
- Provide general support to the validation group to meet department goals and objectives
- Generate/execute System Impact and Critical Aspect Assessment Impact, Pre-move Test documentation, and Commissioning Test packs
- Troubleshoot issues of diverse scope where analysis of data requires evaluation of identifiable factors
- Working knowledge of utilities, cleaning validation, and general production systems used in pharmaceutical manufacturing
- Experience qualifying equipment and systems: incubators, autoclaves, clean utilities
- Strong working knowledge of statistics and analysis tools
- Knowledge of validation principles, including: validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ and process validation
- Perform Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state
- Perform change control assessments and assign associated validation activities to ensure compliance with regulatory requirements
Education
University of New Mexico Valencia Campus
2005 - 2009
Engineer's Degree in Engineering
Professional Skills
- Strong root cause analysis skills with cGMP experience. Excellent Verbal and written communication skills
- Solid experience in applying statistical methods into verification and validation of products and processes, and needed supportive IT and analysis skills
- Demonstrated computer skills and experience using Microsoft Word and Excel required
- Act as a Site Validation expert in one or more specialist areas of validation (i.e. CSV, Cleaning Validation, Process Validation)
- Experience in Cleaning Validation, Process Validation, Equipment Qualification, Performance Qualification and/or Filter Validation
- Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
- Working with ITS Project Leader (IPL) and Validation Expert (VEX) to develop validation deliverables as per agreed validation and test strategy
How to write Validation Specialist Resume
Validation Specialist role is responsible for technical, organizational, interpersonal, validation, computer, microsoft, analytical, organization, software, database.
To write great resume for validation specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Specialist Resume
The section contact information is important in your validation specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Validation Specialist Resume
The section work experience is an essential part of your validation specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous validation specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular validation specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Specialist resume experience can include:
- Demonstrate a thorough understanding of biopharmaceutical equipment, cleaning processes and validation procedures for Operational Qualification (OQ) and Performance Qualification (PQ). Develop validation protocols from Validation plans and engineering documents
- Demonstrated effective interpersonal skills with an ability to interface well at all levels. Good oral and written communication skills
- We are looking for a strong energetic team player with good communication skills, capable of dealing with complex and divers situations
- Strong word processing and spreadsheet skills, including processing of formulas
- Demonstrated experience in writing and reviewing validation reports
- Good planning, organizational and time management skills, and the ability to communicate at all levels
Education on a Validation Specialist Resume
Make sure to make education a priority on your validation specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Validation Specialist Resume
When listing skills on your validation specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical validation specialist skills:
- High level of analytical skills with proven problem-solving ability, and good interpersonal skills
- Good communication skills both verbal and written. Good presentation skills
- Good communication and writing skills. Knowledge and application of current validation regulations, guidance’s and processes
- Excellent computer and PC skills including experience with MS Office, statistical, and database applications
- Strong interpersonal skills and demonstrated ability work independently
- Strong communication skills and good logic thinking
List of Typical Experience For a Validation Specialist Resume
1
Experience For Computer Validation Specialist Resume
- Work as a team member on cross functional teams executing complex project implementations. Strong technical writing skills
- Effectively communicate, directing and guiding personnel who are not direct reports with both technical and non-technical experience
- SOP’s pertaining to Catalent Pharma Solutions Validation and production equipment, and/or process validation and/or cleaning validation
- Strong technical report writing skills with a high level of attention to detail with ability to identify errors during documentation review
- Strong preference given to candidates with packaging validation experience
- Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner
- Demonstrate skills in problem-solving, system design, application of technological and business tools and the use of IT systems
- The ability to deliver competent and effective planning, coordination, and poses great organizational skills
- Excellent technical writing, communication, and organizational skills
2
Experience For Computer System Validation Specialist Resume
- Experienced in the development of validation protocols, management of the execution of validations, and in the writing of final reports
- Excellent interpersonal, leadership, communication (written and verbal) and time-management skills are essential
- As a clinical validation tester communicate clinical validation timeline risks, resource needs, and status updates to the clinical validation lead
- Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts
- Able to interact with personnel of all levels, including customers: interpersonal, influencing, listening skills
- Experienced with temperature mapping and instrument experience (Spectrometers, HPLC, plate reader, balance, etc.) for generating and executing protocols
- Experience with Solid Dose Manufacturing and Packaging Equipment
3
Experience For Software Validation Specialist Resume
- Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
- Experience in validation / sanitation process development in a food or beverage related manufacturing setting
- Strong background in GMP environment with an understanding of the basic compliance requirements regarding validated systems
- Create VMP, validation Plans and Protocols including DQ, IQ, OQ, PQ, process validation and cleaning valiation
- Experience with increasing responsibility in life sciences, biotech or other FDA regulated validation involving equipment
- Prepare and report the validation maintenance activities for process, equipment, cleaning or utilities engineering through validation review reports
4
Experience For Computer Systems Validation Specialist Resume
- Strong working knowledge in validation methodology and software development life cycle (SDLC) principles
- Experience of validation test script authoring is highly desirable
- Experience in performing analytical computerized instrument and software validation
- Experience in a pharmaceutical environment working with the validation and qualification of equipment, utilities, and facilities
- Working experience required in validation or comparable area in the pharmaceutical or consumer health industry
- A sound industry knowledge and a solid technical understanding of the validation element principles and procedures
- Experience in a quality systems environment, or equivalent work experience
- Experience with validation of methods or processes in relation to requirements
- Maintain validation equipment in a state of calibration and compliance to support the company’s validation efforts
5
Experience For Qualification & Validation Specialist Resume
- Validation experience within a GMP environment
- Develop Validation Master Plan for requalification or prospective validation
- Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities
- Working knowledge of IVD product process development for manufacturing and product validation
- Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements
- Assisting system owners with impact assessments and identifying qualification/validation requirements
- Carrying out all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
- Keeping up-to-date with GSK internal policies, standards and best practices (e.g. validation, IT, Engineering, Analytical Equipment)
6
Experience For Senior Validation Specialist Resume
- Experience prolonged standing, some bending, stooping and stretching
- Collaborate with Manufacturing, Engineering, IT, QA and QC to maintain the existing systems in a Validated and Compliant state
- Two years of technical writing including investigations, procedures, training and/or validation documents
- Experience including clean utilities, facility systems, process support systems, bioprocess manufacturing and packaging equipment is desirable
- Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations
7
Experience For Business Validation Specialist Resume
- Preference given to candidates possessing two or more years experience working in the pharmaceutical, biotech, or medical device industries
- Supports trouble shooting of equipment and system as needed to respond to unsuccessful validation testing
- Validation of aseptic process (formulation, filling, holding times)
- . Experience in writing protocols/reports for one or more of the following
- Maintain working knowledge of Good Manufacturing Procedures (GMPs)
- Familiar with or able to quickly pick up knowledge in all areas concerning validation in a pharmaceutical packaging environment
8
Experience For Product Validation Specialist Resume
- Esperienza di base in materia di cleaning verification e cleaning validation
- Good working knowledge of biologic unit operations, including fermentation and purification methods and equipment
- Able to represent Equipment and Cleaning Validation as a System Matter Expert (SME)
- Trainer on Equipment and Cleaning Validation philosophy, approach and procedures
- Provides support or training to client on validation policies and procedures
- Multitask and flexibility to adapt to changing priorities
- Assist with preparing validation final report packages
- Skilled in aseptic processing and the use of single use technology
- Preparation and execution of validation protocols (equipment, cleaning, computerised systems and processes)
9
Experience For Equipment Calibration & Validation Specialist Resume
- Excellent planning and time management ability
- Provide training to staff on validation policies and procedures
- Prepare and/or review protocols and reports supporting the validation of equipment, systems and processes
- Use a risk based approach for problem solving and prioritisation of tasks
- Guide, train and mentor individuals / groups involved with the writing and execution of validation activities
- Maintain the validation schedule and keeping all equipment and processes in a qualified state to support certification standards
- Assist system owners with impact assessments and identifying qualification/validation requirements
- Supervise all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
10
Experience For Senior Software Validation Specialist Resume
- Manage outsourced validation activities associated with development and ongoing production
- Establish the Validation Strategy for modifications, improvements, and Capital Projects to be implemented in the Manufacturing Areas
- Industrial Quality Control, Quality Engineering, Quality Assurance and Validation
- Design, execute and analyze manufacturing process validation studies
- Execute the Validation Plans for medical device and pharmaceutical product manufacturing equipment and facilities
- Provides expert technical IT guidance to the Head of Quality for GMP decisions regarding the validation of computerized systems
- Monitor and report validation costs including capital and cross-functional expenses
- Provide technical assessment and validation review/approval for facility, process and standard operating procedure changes
- Analyzes all validation data per standard operating procedures
List of Typical Skills For a Validation Specialist Resume
1
Skills For Computer Validation Specialist Resume
- Analytical thinking and good problem solving skills
- Experience with validation of IS computer systems in an FDA regulated environmentUnderstanding of GxP regulations and computer validation principals
- Demonstrated technical writing and oral communication skills
- Good communication, interpersonal, technical writing skills
- CGMP and validation skills
- Strong experience writing and executing system validation & equipment qualification documents
- Pharmaceutical Validation, Bio Pharma Validation, Validation execution
2
Skills For Computer System Validation Specialist Resume
- Good analytical, technical, and communication skills, both written and oral
- Developing the Validation Master Plan and submitting validation reports for approval
- Validating and coordinating protocols and reports on validation/qualification
- Critical thinking skills and making contributions to the product development and operations as part of a well integrated team
- Project management skills, particularly related to scheduling of systems and periodic reviews
- Basic writing and communication skills
- Verbal and written English skills
- Engineering validation experience in the pharmaceutical/biotechnology industry
- Experience in analytical validation
3
Skills For Software Validation Specialist Resume
- To be conscientious, dependable, adapt well to change, and work effectively with a global / culturally-diverse team
- Able to communicate with customers, PerkinElmer service engineers and management effectively on subject matter
- Interact effectively with laboratory personnel, QA, and Facilities groups
- Previous experience in validation of computer systems
- Responsible for planning, scheduling, execution of the qualification/validation projects in accordance with Good Laboratory Practices (GLPs)
- Computer systems validation experience is required
4
Skills For Computer Systems Validation Specialist Resume
- Be self-motivated, flexible, organized and a good team player with the ability to prioritize own work based on departmental and site requirements
- Contributing to continuous improvement and International standardization for topics related to process and cleaning validation,
- Working knowledge of process and cleaning validation
- Working knowledge of Computer System Validation
- Developing, implementing and improving the validation / qualification system at the company
5
Skills For Qualification & Validation Specialist Resume
- Participating in the development and implementation of activities aimed at improving the effectiveness of the Pharmaceutical Quality System at the company
- Monitoring the implementation of the validation program across the company
- Understanding of validation/qualification strategies
- Training of personnel in validation practices
- Experience and understanding of lean manufacturing principles
- Coordination, planning and supporting of validations/qualifications for processes and IT tools
- Writes and facilitates Cleaning Work Instructions, Engineering Studies and Validations
- Provide guidance to third party workers during testing on second and third shifts and weekends and communicate issues to the clinical validation lead
6
Skills For Senior Validation Specialist Resume
- Perform cleaning validation of manufacturing equipment used for products
- Co-ordinate and communicate with Engineering, Production, Planning & Quality teams on different validation activities and their responsibilities
- Our client is looking for someone to join an existing team of chemical engineers to validate recipes used to manufacture biopharmaceutical products
- Assists in maintaining and updating XBL’s Validation Master Plan (VMP)
- Responsible for developing and maintaining validation standards on track with regulatory and GSK Vaccines Division
7
Skills For Business Validation Specialist Resume
- Responsible for creating the training materials for validation for the division
- Strong working knowledge of MS Office Suite Applications, statistics and analysis tools
- Good knowledge of production equipment, analytical equipment, facilities, engineering and instrumentation
- Quality assurance or quality control experience in a cGMP pharmaceutical setting
- Prepare process and cleaning validation protocols, conduct execution of protocol and write summary report after the completion
- Computer Systems Validation expert that includes the following
8
Skills For Product Validation Specialist Resume
- 2 – 3 years’ experience writing CSV test scripts, protocols and summary reports
- Experience in 6-Sigma and Lean Manufacturing
- Ensure traceability of validation filing
- Thorough knowledge of cGMP and regulatory requirements for validation
- Code of Federal Regulations and cGMPs as related to Validation, electronic records, and electronic signatures
- Experience working within Biotech
- Experience in fermentation process - REQUIRED
9
Skills For Equipment Calibration & Validation Specialist Resume
- Experience in support of internal and external audits, completion of audits responses and corrective actions
- Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP)
- Experience in using automated enterprise testing tools is an asset in order to support and assist company’s testing initiatives
- SME level of understanding of bio pharmaceutical manufacturing equipment and the role of validation
- Generation, execution and close out of validation projects relating to existing products and new product introductions
- Perform validation functional testing as required. Track and resolve deviations during qualification activities
- Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable
- Strong knowledge and understanding of applicable regulatory and quality requirements and standards required
- Participate in project teams and assist in determining project schedules and the appropriate levels of validation
10
Skills For Senior Software Validation Specialist Resume
- Execution and documenting risk assessments (FMEA) with respect to validation activities
- Extensive experience training group members and contractors on procedures, policies and other documents
- Performs specific development and validation related laboratory tasks as assigned by Supervisor
- Technically write validation (PPQ) protocols and reports
- Collect, table, and analyze the generated data for the validation (PPQ) reports
- Interpret and draw conclusions to establish and defend the validation (PPQ) status of a process and identify trends
- Innate ability to learn new software as required for equipment qualification and system validations
- Perform Change Control validation assessments
- Generate Validation Master Plans
List of Typical Responsibilities For a Validation Specialist Resume
1
Responsibilities For Computer Validation Specialist Resume
- Excellent oral and written communication skills and excellent interpersonal skills are essential
- Excellent scientific knowledge of analytical techniques, good interpersonal and organisational skills are required
- Organizing Validation projects, optimizing the Validation System, Plan & Track Validation Projects, Participate in Audits
- Be self-directed and possess strong critical thinking skills
- Of experience in a GXP environment or validation of IT applications, or an equivalent combination of education and experience
2
Responsibilities For Computer System Validation Specialist Resume
- Learn and demonstrate understanding of all Validation Department plans, standard operating procedures and validation protocols related to assigned projects
- Proven experience as a technician in CT/PET. Experience in PET is an advantage
- Excellent written, verbal and interpersonal communication skills, highly organized and detail-oriented
- Excellent SQL query skills, preferable Oracle
- Good computer skills with knowledge of HP Quality Center/Genilogix and Microsoft Office programs (Word, Excel, Outlook)
- Tracking and maintaining the Annual Validation Schedule and regularly updating progress to the European Validation Manager and Site Leadership
3
Responsibilities For Software Validation Specialist Resume
- Provide SDLC validation doc authoring and project management services to validated 39 new laboratory instrument systems
- Ensures validation protocols, reports and supporting evidence are properly documented, archived and stored for timely retrieval
- EU/APAC: Prior relevant experience in software testing
- Demonstrable validation experience in a medical device ISO13485, biopharmaceutical (chromatography, ELISA), consumer healthcare or related industry
- Ideally, 3 years validation experience within a GMP environment
- Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, microbiology, consumer healthcare or related industry
4
Responsibilities For Computer Systems Validation Specialist Resume
- Lead the Validation Working Party acting as a validation subject matter expert
- Write, review and approve Validation documents (validation protocols, SOPs, CQP, DP, RIAS, MVP...etc.) according to Shire and Regulatory standards
- Participate in validation activities from strategy, planning, execution to validation report
- Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner
- Previous experience with process design for biomanufacturing facilities and equipment validation
- Define the validation approach and managing all aspects of the SDLC approach for Computer System Validation projects
- Operates Kaye validation equipment and interprets resulting data
- Handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management
- Validation and implementation of new or transferred manufacturing process and cleaning validations
5
Responsibilities For Qualification & Validation Specialist Resume
- Design and execute engineering (pre-validation) studies to support validation activities
- Identify gaps related to validation requirements and Global Validation procedures. Drive and close compliance gaps as they are identified
- Perform update to element validation assessments and validation plans, as required
- . Experience in, Process Validation (formulation and/or filling), , Performance Qualification,
- Validation experience with manufacturing facilities/areas (e.g. multi-product facility, warehouse, cold rooms, autoclaves, depyrogenation ovens)
- Hands-on Experience in computer system specification development and validation
- Laboratory Equipment and Computer System/Software Validation experience
- Software/Systems Validation and Risk Management experience in the medical device industry required
6
Responsibilities For Senior Validation Specialist Resume
- Effectively and directly interface with business and technical personnel at various levels
- Visual acuity skills, needed to distinguish color, fine lines, and nonconformities in products and materials
- Including aseptic processing systems oversight (media fill, VHP validation, Environmental Monitoring)
- Carrying out all validation activities on equipment before handover or return to system owner and updating relevant records and schedules
- Generating the Annual Validation Schedule once risk, impact and business needs have been assessed with key stakeholders
- Approving documents related to Validation (i.e. URS)
- Responsible for authoring, reviewing, executing and approving validation documents
7
Responsibilities For Business Validation Specialist Resume
- Coordinates validation activities with Manufacturing, Converting/Packaging, Quality Control and Technology Transfer departments
- Three years of technical writing including investigations, procedures, training, and/or validation documents
- Extensive experience writing CATIA scripts using both VBA and CATVbscript
- Manage all validation activities including research, protocol writing, execution and final report approval
- Good at communicating and working with others in cross functional groups
- Coordinate execution of all validation activities at TILGC including the following
8
Responsibilities For Product Validation Specialist Resume
- Develops validation plans and schedules including annual cleaning verification schedule
- Generation / execution of equipment and/or process validation protocols and reports, including gap analysis of existing protocols against industry standards
- Manages laboratory computerized system implementation projects including scheduling, site prep, installation, validation, and turn over to business area
- Assist with preparing and executing validation protocols
- Assist with preparing and maintaining validation final report packages
- Assist with trouble shooting and investigating validation-related issues
- At least two years of working experience in manufacturing of pharmaceutical products
- Validation training and instruments training to business team and customers
9
Responsibilities For Equipment Calibration & Validation Specialist Resume
- Performs process validations including process flowcharting to determine critical steps; generates data to prove stability and capability of the process
- Coordinate execution of validation activities including the following
- Experience working with GAMP5 risk-based approach and 21 CFR Part 11 and cGMP regulations
- Provide guidance to B.Braun US and Global operations concerning computer system validation requirements and standards that can impact CAPS operation
- Good working knowledge of Pharmaceutical (USP , 21 CFR 210 & 211, and 503B) and Medical Device (21 CFR 820) Quality System Regulations
- Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
10
Responsibilities For Senior Software Validation Specialist Resume
- Project Management experience, including project initiation, team development, and desired results on time, on scope, and on budget
- Provides Business Support/Training to Users for Thermo Scientific’s Watson LIMS System and other Validated Systems as assigned
- Interacts directly with customer on cleaning assessments, deviations, and validation strategy for assigned projects
- Provide validation expertise in the Alofisel® Production area ensuring compliance with current industry regulations, guidelines and trends
- Participate in cross functional project teams and assist in determining project schedules and appropriate levels of validation
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