Syner-G
Sr. Fill Finish Process Engineer (Future Opportunities)
San Diego, California, United States · Senior
No sponsorshipDetected 36 days ago
Supply ChainProcess ImprovementControlsVoIPGMPFDA RegulatoryLeadershipCommunicationProblem SolvingWriting
About the role
- We are actively seeking qualified candidates to join our talent pipeline for future client engagements.
Responsibilities
- Support design, construction, installation, and qualification of a new commercial fill-finish suite, including cleanrooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
- Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- Bachelor's or Master's degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning, qualification, and engineering documentation.
- Strong understanding of aseptic operations, cleanroom environments, and fill-finish equipment.
- Ability to work independently and collaboratively.
- Knowledge, Skills, and Abilities
- Travel to client sites may be required up to 100% based on project phase and client needs.
- 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.
- While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse
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
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
- Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
Benefits
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
- Specific vision abilities required by this position include close vision and the ability to adjust focus.
Company info
- We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.
Equal opportunity
- LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers.
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.