Validation Engineer
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Job Description
Validation Engineer ensuring compliance with internal quality standards in biopharma equipment and manufacturing processes. Supporting validation activities, tech transfer, and continuous improvement initiatives.
Responsibilities:
- Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
- Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
- Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
- Prepare summary reports for validation, verification, commissioning, and requalification activities.
- Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
- Perform P&ID walkdowns to verify installation and system readiness.
- Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
- Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
- Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
Requirements:
- Bachelor’s degree in a life science, engineering, or related technical field.
- 4–7 years of experience in the biotech, pharmaceutical, or medical device industry.
- Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
- Hands‑on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation.
- Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
- Demonstrated experience writing IQ, OQ, PQ, and CSV reports.
- Strong verbal and written communication skills, with the ability to explain technical concepts to non‑technical stakeholders.
- Detail‑oriented with strong organizational and documentation skills.
- Ability to work independently and collaboratively in a fast‑paced, regulated environment.
- Strong problem‑solving skills and the ability to support investigations and root‑cause analysis.
Benefits:
- market competitive base salary and annual incentive plan
- robust benefit offerings
- ongoing recognition and career development opportunities
- generous flexible paid time off program
- company-paid holidays
- flexible working hours
- fully remote work options for most positions
- office locations in Greater Boston; San Diego, CA; Boulder, CO; and India
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