Validation Resume Sample
Gwendolyn Kling
1089 Collier Crossroad,
Houston,
TX
+1 (555) 211 8373
Work Experience
Validation Associate
04/2016
-
PRESENT
Phoenix, AZ
- Review and revise system related SOP’s (Standard Operating Procedures), WO’s (work orders), QOPs (Quality Operating Procedures), CSV and all other department standards and compliance documentation as applicable
- Provide updates and interact with key stakeholders involved with system qualification (e.g. Quality and Compliance, SCS, RA’s, PM’s, QC, Product Owners etc.)
- Flash technologies in storage arrays, SCSI, Fibre Channel, SAS and trace analysis expertise
- Develop a sound program to validate all corrective actions completed by the business, this includes but is not limited to: process, formats, timelines, validation routines and forums, reporting, approvals, etc
- Applies solid understanding of Internal Audit validation practices to accomplish the objectives of the function
- Review the corrective action(s) performed by the business and validate that the completed corrective action
- Fully addresses the open issue and adheres to the deliverables/commitment (CAP) made by the business/issue owner
- Meets all Internal Audit requirements governing the validation of correction actions
Validation & Verification Engineer
09/2011
-
10/2015
New York, NY
- Conduct credible challenge and provide Senior Management with value added feedback to verify issues have been appropriately resolved
- Work closely with business line risk management, subject matter experts, and IIV management to address matters of concern and ensure issues are properly remediated
- Identify trends, including repeat issues and inadequate corrective actions taken by business line
- Perform periodic re-testing to verify the adequacy of business unit and testing team remediation
- Create reporting for management based on the results of the validation review
- Wearing a static protective smock at all times while in the work area
- Working in close proximity to other employees
Product Validation Intern
08/2008
-
08/2011
Chicago, IL
- Based on observed validation results, recommends appropriate and pragmatic solutions to open corrective actions. Identifies inconsistencies in data or results and formulates recommendations on approach, procedures or practices
- Partners with Business/CAP owners to ensure that closed CAPs are correctly documented in corresponding corporate systems (currently iCAPS)
- Develops analytical programs to deeply test and validate holistic datasets
- Recruits staff for the Controls Validation team, develops talent, builds effective teams, and manages tight deadlines. Provides coaching to team members in all phases of the validation process
- Delivers high quality corrective action validation results on a timely manner
- Validate resolution plans to ensure they adequately address the root cause of identified issues found in the business lines and evaluate whether corrective actions are sustainable
- Conduct a detailed review of evidence to support the closure and remediation of issues
- Perform detailed re-tests to support issues have been effectively implemented and the related risk exposure has been reduced
Education
Waynesburg University
2003 - 2007
Engineer's Degree in Engineering
Professional Skills
- Solid negotiation skills and the ability to handle many conflicting priorities with proven organizational skills
- Demonstrated interpersonal skills including strong negotiations and facilitation skills
- Excellent problem solving skills, communication skills and ability to scope & plan work required
- Detail oriented, self-motivated, strong leadership skills with demonstrated ability to guide and influence large teams effectively
- Strong risk, process and control validation/testing/auditing skills
- Strong bringup and debugging skills and hands-on lab work. Experience with complex test equipment setups for analog
- Working knowledge and proven PC computer skills; including Microsoft Office Applications (Outlook, Word, Excel, and PowerPoint)
How to write Validation Resume
Validation role is responsible for computer, interpersonal, analytical, technical, engineering, programming, validation, software, architecture, microsoft.
To write great resume for validation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Resume
The section contact information is important in your validation 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 Resume
The section work experience is an essential part of your validation 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 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 position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation resume experience can include:
- Strong interpersonal and communication skills. Ability to effectively collaborate with others to achieve team goals and expectations
- Team player and good organizational skills including the ability to prioritize, handle multiple projects simultaneously and meet deadlines
- Team management experience. Good planning skills
- Attention to detail and organizational skills with analytical and problem solving skills required
- Demonstrated programming skills including SAS and implementation of new reporting/analytical functionality using SAS
- We are looking for someone with at least 1 year of programming experience and with 0-2 years’ experience in validation/testing/quality assurance
Education on a Validation Resume
Make sure to make education a priority on your validation resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation 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 Resume
When listing skills on your validation 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 skills:
- Computer software skills, organization skills, record keeping and planning skills, time management skills, facilitation skills, supervisory skills
- Written and oral communication skills, team building skills, independent work skills, strong work ethic
- Demonstrated leadership , logic design skills, time management and problem solving skills
- Communication Skills - Demonstrates ability to effectively communicate with peers, supervisors and lab support staff
- Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management
- Expert in RF Testing, excellent technical skills on the intersection between application and product, good understanding of cellular & WLAN systems
List of Typical Experience For a Validation Resume
1
Experience For Validation Associate Resume
- Good analytical skills and ability to communicate effectively with all levels
- Thorough understanding and capacity to effectively operate in all phases of the vehicle development process
- Excellent cross-functional teamwork, communication, analytical and presentation skills
- Document work and effectively prioritize documentation
- Develop and execute Test method validations (TMVs), IQ/OQ/PQ validations, and software validations
- Excellent writing and computer skills. Familiarity with software such as MS Office, Adobe Acrobat, and SAP
- Excellent written and verbal presentation skills to support interactions with engineering management are required
2
Experience For Lead Validation Engineer Resume
- Sound experience in IQ, OQ and PQ validation protocols, procedures and documentation with process, equipment, cleaning or facilities validation
- Track record of working well in cross-functional environments, strong presentation and written/verbal communication skills
- Serves as validation liaison with clients on validation issues. Coordinates, reviews and prepares validation documents
- Use of validation test equipment, such as, Kaye Validator and Ellabs loggers in support of validation activities
- Excellent communication skills and ability to work in a team are completing your profile
- Experience in GMP manufacturing equipments, and processes, validation experience is an advantage
3
Experience For Senior System Validation Engineer Resume
- Experience in GMP manufacturing equipment, and processes, validation experience is an advantage
- Understanding of network interface probing concepts and skills
- Programming skills in C and/or C++, Python or other scripting languages
- Possessing good analytical, problem solving skill
- Working effectively with calibration experts across the company
- Understanding of NAND memory fundamentals Validation or QA experience
- Mobilising your technical skills and knowledge to facilitate improvements and be of maximum benefit to the wider team
4
Experience For Principal Validation Engineer Resume
- Bring-up server system, implement product hardware system validation, and debug platform hardware issues captured in validation
- Responsible for performing validation maintenance / review through preparing protocols, collecting evidences and reporting to section head
- (As required) Move to others areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
- Project management skills, including creating / managing project budgets, resources (internal and external) and schedules
- Responsible for creating and having input to specific documentation, i.e., Product Requirements Definition, Validation Plan and Validation Report
- Understand, document, present, design, develop, deploy and support data cleansing, consolidation, validation and reporting processes
- Proficient computer skills including creating presentation
- Familiarity with Good Manufacturing Practices and Regulations governing validation activities
- Solid computer science understanding/experience in scripting languages (C/C#, Perl, Python, Powershell)
5
Experience For Validation & Verification Engineer Resume
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
- Experience in mechanical and structural testing and a deep understanding of the FMEA process and validation cycle
- Experience performing IP and/or SoC functional validation using System Verilog
- Communicate effectively Knowledge of Heat treat, steel making and Casting processes
- Prior experience in a line role or supporting a finance or reporting function
- Experience preparing/authoring technical documentation / validation protocols
- Experience in Validation automation and scripting/programming languages such as LabVIEW, C, C#, Python or similar
- Experience in Validation automation and scripting/programming languages such as LabVIEW, TestStand, C,/C++, Python or similar
- Develop skills in requirements review, test case generation and supporting documentation authoring
6
Experience For Process Validation Engineer Resume
- Independent validation, review of design and operating effectiveness of select Market Risk, Credit Risk, and CCAR processes and controls
- Profound working experience in Validation
- Effectively provide direction and training to other engineers
- · Work as a self-motivated individual in a team environment communicating effectively with all levels internal and external to the PET
- · Maintain calibration of Validation equipment and support cleaning validation activities through prep and facilitation for operator qualification
- Reviews Validation Engineering and Validation Test related processes and procedures for applicability
- Rudimentary scripting skills (Python & JavaScript)
7
Experience For Validation Coordinator Resume
- Excellent working knowledge of Microsoft Office (Word, Excel and PowerPoint) and data entry experience
- Relevant experience in RF testing (validation or application)
- Good understanding of healthcare/pharmaceutical/medical device IT validation expectations
- Experience validating computer systems within a regulated environment
- Prior experience with debugging in NVMe and SATA drives
- Strong experience in static/dynamic power and thermal characterization, modelling and enablement of product rollout
- Experience performing IP and/or SoC functional validation
8
Experience For Systems Validation Engineer Resume
- CAD skills, including the ability to interpret drawings, datum schemes and tolerance
- Experience in testing and validation
- Experience in developing Register Transfer Level RTL validation environment
- BS in relevant Engineering/Science field. Other degrees acceptable with 3-5 years of relevant and recent validation/qualification experience
- Experience working on pre-Silicon validation/verification required
- Supports all validation activities at MTI as part of the validation team, including those related to data integrity activities
- Electronic Systems Engineering Integration and Validation (test plans, test procedures, test cases) experience
- Strong Analysis and Troubleshooting experience
9
Experience For Associate Validation Engineer Resume
- Previous experience with sterilizers, controlled temperature units, plant utility systems, cleaning validation, and/or process development
- Experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment (required)
- Drive exploration of IP validation methodology, platform and infrastructure enablement to improve process and throughput Validation report writing
- Ensure that the highest quality, most efficient and cost effective validation and compliance services are delivered to our clients
- Maintain and implement the Validation Master Plan along with a periodic progress report to the Validation Manager
- Able to troubleshoot validation equipment problems and validation issues in consultation with subject mater experts and management
- Experience in the industry, preferably chip and/or system Validation
- Responsible for validation procedures, template creation and software validation process improvements
10
Experience For Hardware Validation Engineer Resume
- Professional verbal and written communication skills and ability to manage technical details with customer
- Create and execute validation protocols for scale-up, optimization studies, and process validation
- Fluent in English, German language skills are highly beneficial
- Clearly and effectively write technical documents
- Coordinate product process validation, cleaning validation, media fills & air system qualification activities
List of Typical Skills For a Validation Resume
1
Skills For Validation Associate Resume
- Direct experience in Computerized System Validation activities and strong QA analyst skills required
- Strong organisation skills with the ability to multitask and prioritise; ability to work under pressure
- Well organized, strong work ethic and good interpersonal communication skills
- Good organizational skills; able to plan and prioritize tasks to align with the organization's goals
- Communicate effectively at all levels in verbal (soft skills) and written form, including technical/business writing
- Act as thought leader in all aspects of issue assurance/validation, leveraging prior experience in effective audit practices and project management
- Demonstrates team skills. Has the ability to multitask (working on multiple projects concurrently or working on multiple aspects of the same project)
- Excellent problem solving skills and attention to detail for an understanding of silicon, board, and software interactions
2
Skills For Lead Validation Engineer Resume
- Solid verbal and written communication skills, including technical / business writing
- Validating mixed signal hardware, ideally some experience validating ASICs
- Strong problem solving skills and ability to apply problem-solving tools
- Analytical thinking with excellent problem solving skills
- Strong communication and partnering skills for working with both Technology Operations Services and Business Line partners
- Strong networking skills - ability to work in a cross-functional environment with several interacting teams
3
Skills For Senior System Validation Engineer Resume
- Interacts, communicates effectively and builds strong working relationships on an ongoing basis with business and IT partners
- Strong communication(oral and written) and presentation skills targeting a variety of audiences
- PowerPoint skills—experienced in creating presentations in PowerPoint
- Good programming skills in C or C++/C#
- Experience with programming and debug skills
- Experience with Pre and/or Post Si System Validation- Experience with Early Prototyping Emulation, Simics, FPGA
- Experience: 3 yrs in GMP-regulated industry, preferably medical device or pharmaceutical, 2+ years experience performing instrument validations
- Excellent analytic, problem solving and organizational skills
- Effective communication skills working across large cross-functional HW, SW, architecture teams
4
Skills For Principal Validation Engineer Resume
- Demonstrated ability in Technical writing skills
- Demonstrated history of effectively communicating with geographically dispersed teams
- Excellent interpersonal communication skills and comfortable at interfacing with all levels of management
- Logical and creative thinker with demonstrated problem solving skills and attention to detail
- Strong oral and written communication skills with exceptional attention to detail
- Have very strong skills in Root Cause Analysis (RCA) and problem resolution
- Excellent Teamwork, Communications (Written and Verbal), and Organizational skills
- Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines
- Excellent analytical skills (Jmp or Minitab) and problem solving abilities
5
Skills For Validation & Verification Engineer Resume
- Good knowledge and basic skill/experience on C or C++ program
- Good communication skills - both written and oral in English
- Prior experience within Operational, Market, Credit and/or Liquidity Risk, preferably within process validation or internal audit
- Strong communication, analytic, risk management, and computing skills
- Strong written and verbal communication skills. English fluently both in spoken and written language
- Experience in script based bench automation is required. Experience in validation of high-speed IO is required
- Excellent verbal or written communication skills
6
Skills For Process Validation Engineer Resume
- Strong analytic, risk management, and programme management skills
- Excellent communication, analytical, risk management and program management skills
- Good communication and/or interaction skills among groups inside and outside of Israel
- Excellent communication and interpersonal skills- Self-motivated and results oriented
- Demonstrated leadership capabilities and expert project management and organizational skills are required
- Good command of English language and Computer skills
7
Skills For Validation Coordinator Resume
- Negotiation skills with ability to operate in a team environment
- A self-starter with strong technical leadership skills in the are of design and analysis for structures
- Strong analytical skills, preferably in a GCP environment
- Strong MS/Office skills in particular with Excel and Word
- Demonstrated collaboration and teamwork skills
- We would like someone to join our team who is open-minded, result driven, with excellent client facing, communication and interpersonal skills
- Experience in FDA regulated environment with good understanding of GxP related processes including Risk Based validation
8
Skills For Systems Validation Engineer Resume
- Prior internship experience with bring-up or validation of complex hardware systems with variety of interfaces and peripherals
- Documentation Skills - Demonstrates ability to write fluently to describe test results and part conditions. Writes concisely and accurately
- Experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance
- Good oral and legible written communication skills
- Strong organizational skills and ability to focus on multiple tasks at the same time
- Good written and verbal communication skills in English. Other European language is an asset
9
Skills For Associate Validation Engineer Resume
- Experience in Quality and Compliance with substantial hands-on computer system validation experience
- To support the Validation Manager Europe with transportation validation, packaging validation and equipment qualification as required
- Good communication skills with all levels within the business
- Innovate, influencing and people skills have to be excellent
- Excellent verbal, written communication, and data presentation skills
- Overall experience in validation/test experience
- This job requires a team player with good technical, planning, and communication skills who is motivated to deliver quality test results in a timely manner
- Used to working in an international environment with good oral and written communication skills in German and English
10
Skills For Hardware Validation Engineer Resume
- Good communication and interpersonal skills to work with different teams
- Strong analytical and communication skills (verbal and written, including group presentations)
- Demonstrated experience compiling and executing validation protocols (IQ, OQ, PQs) for various engineering projects
- Excellent trouble shooting and problem solving skills and ability to think logically and be proactive
- Specific experience in Cleaning Validation (Solid Dosage preferable) is required
- Excellent interpersonal and communication skills; integrative team working style
- Professional Skills, Qualifications, and Experience
- Strong people and team skills
- Strong experience with verification or validation of networking ASIC
List of Typical Responsibilities For a Validation Resume
1
Responsibilities For Validation Associate Resume
- Developed problem solving and project management skills as demonstrated by previous work experience
- Knowledge and experience in object oriented languages C++/C- Good English skills for verbal communication and technical documentation authorship,
- Develop and execute Test Method Validations (TMVs), IQ / OQ / PQ validations, and software validations
- Demonstrated prior experience with RF testing tools and WLAN performance environments, defect tracking and revision control
- Strong communication skills with the ability to clearly articulate issues and provide high-level summaries are required
- Excellent communication, analytical and development skills
- Experience in Validation or Quality Departments. Or an equivalent combination of education and experience
- Professional CSV, QA or business analysis experience, with strong relationship management, account management, and support experience
- Experience in testing of protocol checks for validating ECU programming, EEPROM read/write
2
Responsibilities For Lead Validation Engineer Resume
- Good understanding of QSR and ISO 13485 requirements relating to product realization and process validation
- Demonstrate leadership in owning SSD Product Validation Programs and delivering to commits on Execution milestones
- Leads and assists in developing validation strategies and training internal personnel on validation method, policies and procedures
- Provides on-going validation support to External Partners (CMOs) in resolving validation related issues
- Strong experience in testing automotive electronics or in testing of software applications
- Coordinate product process validation and qualification in the scope of PQ project and Technical Equipment/Cleaning Validation
- Previous Testing/Validation experience
- Stay up-to-date on all regulatory requirements and best industry practices for implementing an effective validation program
- Review validation documentation and qualification work executing validation where necessary
3
Responsibilities For Senior System Validation Engineer Resume
- Technical writing skills in English and German
- Oversees all aspects of validation activities in the biologics area (equipment / systems / utility / facility qualification, process / cleaning validation)
- Problem solving abilities and documentation skills
- Problem solving skills, exposure to 6 sigma concepts
- Experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment
4
Responsibilities For Principal Validation Engineer Resume
- Strong working knowledge and expertise in the area of Process Validation and Quality by Design (QbD)
- Target-oriented teamplayer, problem solving skills
- Good understanding the higher Linux application development with C, python skill
- Experience with transmission testing procedures, in vehicle or on dynamometer, and other related experienced
- A team player with proven experience in managing a team
- Experience with Kaye Validator operation required
- SME level experience of Validation and Stat Ops processes
5
Responsibilities For Validation & Verification Engineer Resume
- Effectively communicate Schneider Electric expertise to internal and external clients
- Developed interpersonal skills with an ability to interact and influence internal and external customers of various technical abilities
- Computer system or software validation experience in medical devices or pharmaceutical related industry
- Demonstrated knowledge of qualification / validation concepts
- Ensure that all validation activities and documentation are complying with the mandated QMS requirements under direct supervision of Validation Section Head
6
Responsibilities For Process Validation Engineer Resume
- Strong advanced diesel technical background and experience
- Experience as a Pre-Si Validation designer
- Perform updates to element validation assessments and validation plans, as required
- Experience in validation of BIOS FW platform of Server Client with Intel architecture
- Relevant experience in a Hardware and Software Design Verification, and RF Test, or semiconductor design validation
- Validation experience in Biotech/Pharma industries
- Experience in the industry, preferably chip and/or system Validation
- Experience with Pre & Post Silicon Validation
- 1)Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
7
Responsibilities For Validation Coordinator Resume
- Experience in : FPGA, Emulation/Prototyping, Pre Si or Post Si validation, Logic Design, Integration, Complex Debug
- Hires, trains, and leads Engineers, in support of effectively achieving Global Technical Operations goals
- Computer skills including Microsoft Office products (Word, Excel, Visio, Project)
- Experienced with all levels of DC/AC measurements analysis and demonstrate knowledge of Intel system architecture
- Intimate knowledge of C/C++ and solid understanding/experience in scripting languages (Perl, Python, Powershell)
- Experience in validation, debugging across multiple products
- Experience in the industry, preferably chip and/or system Validation
8
Responsibilities For Systems Validation Engineer Resume
- Hands-on experience & track-record of success in pre-silicon validation
- Experience with validation frameworks such as OVM/UVM desired
- 10yrs experience in SSD/Storage device FW and validation test development
- Proven ability to demonstrate analytical capabilities such as modeling, simulation, statistical analysis, and analytical design tools
- Platform Validation or Storage industry experience
- Time management skills to meet deliverables and manage multiple projects
- Position is responsible for the development and completion of documentation on protocols, Validation Master Plans and Validation Summary Packages
9
Responsibilities For Associate Validation Engineer Resume
- System/Subsystem/Component Validation experience
- Demonstrated work experience in a technician role
- Previous experience with validation documentation practices
- Validation experience is required
- Computer skills: Microsoft Word, Excel, PowerPoint, Minitab Software
- Expertise / experienced with analytical instrumentation / equipment / computerized system validations and qualifications
- Extensive experience with the validation and qualification of computer systems / analytical instruments
10
Responsibilities For Hardware Validation Engineer Resume
- Experience in System Verilog Validation Testbenches
- Technical knowledge and experience with validation/qualification of pharmaceutical processes and equipment, as related to sterile products and medical devices
- Experience with Pre and/or Post Si System Validation
- C/C++ software/firmware experience- Embedded/Low level software experience
- Work with Concept Engineers, designers, verification and validation teams across sites to collect requirement on Post-Si validation for both IP Modules and SoC
- Experience in a Technical/Validation Role
- Experience in Computer Systems Validation for regulated environments
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