Syner-G
Sr. Validation Engineer
San Diego, California, United States · Senior
No sponsorship$114k-$137kDetected 1 day ago
VoIPGMPFDA RegulatoryMedical DevicesLeadershipCommunicationMentoringOrganizational Skills
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odds of building a lasting career here
33Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards.
- Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.
- We are seeking a Sr.
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 such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
- Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
- Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
- Lead P&ID walkdowns to verify installation, configuration, and system readiness.
- 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.
- Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
- Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs.
Requirements
- Bachelor's degree in a life science, engineering, or related technical field.
- 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, with emphasis on computerized equipment and systems validation.
- Experience supporting audits, regulatory inspections, and remediation activities.
- Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.
- Ability to mentor junior engineers and contribute to team development.
- Validation Engineer with 7-11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments.
- The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Skills
- A career here is life-enhancing.
- Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
- For more information, visit www.Synergbiopharma.com
Compensation
- The expected salary range for this position is $114,000 to $137,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
Benefits
- Specific vision abilities required by this position include close vision and the ability to adjust focus.
Company info
- At Syner-G, we recognize that our team members are our most valuable asset.
- For more information, visit www.Synergbiopharma.com POSITION OVERVIEW We are seeking a Sr.
Equal opportunity
- LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer.
- Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer.
Visa & Work Authorization
- Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Syner-G's careers page and normalized into a canonical job model.