Validation Engineer III
About The Position
The Validation Engineer III drafts and implements Quality System documentation, including SOPs and Traceability Matrices, to establish good validation practices. The role authors and executes URS, IQ, OQ, and PQ protocols in compliance with GDP guidelines and internal quality standards. It coordinates validation activities with vendors, analyzes and assembles results, and prepares validation reports. The position provides input on user and functional requirements for current and future processing equipment, drafts related documentation, and interfaces with Contract Manufacturers to ensure requirements are met. It also supports R&D, Manufacturing, and other non-engineering staff with technology transfer and continuous improvement. The engineer is expected to complete assigned duties on time, proactively communicate delays and issues to the validation manager and stakeholders, and comply with regulatory, corporate, and Quality System policies.
Requirements
- Degree in engineering, pharmaceuticals, or another relevant discipline.
- At least 5 years of experience working in a medical device environment or another FDA-regulated environment.
- Experience with design documentation, including URS, FRS, DS, and other engineering specifications.
- Experience with validation, including IQ, OQ, PQ, PV, CSV, and MVP.
- Experience with Quality Systems, including Change Control, Non-Conformances, and Requalification.
- Understanding of cGxP principles and familiarity with ISO guidelines.
- Working knowledge of the Computer Systems Validation lifecycle and documentation.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to work independently with adequate supervision, multitask, and support several projects simultaneously.
- Strong communication, interpersonal, and teamwork skills.
- Strong technical writing and presentation skills.
- Ability to lift at least 25 lbs.
- Ability to travel as needed, 20%–30%.
Nice To Haves
- Experience with biological products is highly desirable.
Responsibilities
- Draft and implement Quality System documentation, including SOPs and Traceability Matrices, to establish good validation practices.
- Author URS, IQ, OQ, and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
- Coordinate validation activities with vendors, analyze and assemble results, and draft validation reports.
- Provide input on user and functional requirements for current and future processing equipment, and draft appropriate documentation.
- Interface with Contract Manufacturers to ensure relevant user and functional requirements are met.
- Support non-engineering staff, including R&D and Manufacturing, with technology transfer and continuous improvement.
- Complete assigned duties on time and proactively communicate delays and other issues to the validation manager and relevant stakeholders.
- Comply with regulatory, corporate, and Quality System policies.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
