Senior Validation Engineer
S
Syner-GBiotech Pharmaceutical
Fully remote work options for most positions and the ability to work “almost anywhere.”Full-TimeSenior
Salary$115,000 to $130,000 yearly
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Job Details
- Experience
- 7–11 years
Requirements
- Bachelor’s degree in a life science, engineering, or related technical field.
- 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
- Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
- Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
- Extensive experience generating protocols for automated production systems.
- Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
- Experience supporting audits, regulatory inspections, and remediation activities.
- Strong verbal and written communication skills.
- Ability to lead validation workstreams and manage multiple priorities independently.
- Strong problem‑solving skills and experience supporting investigations and root‑cause analysis.
Responsibilities
- Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
- Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents.
- Write, review, and revise qualification and verification documents, including SOPs, validation master plans, URS, FRS, design specifications, FAT, and commissioning test procedures.
- Prepare comprehensive 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 and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
- Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
- Provide technical mentorship and guidance to junior validation staff.
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