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To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire
Senior Process Engineer
Location
California
Posted
82 days ago
Salary
$125K - $188K / year
Seniority
Senior
Job Description
Senior Process Engineer
Syner-G BioPharma Group
• Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing. • Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution. • Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs). • Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs). • Conduct data trending, process performance assessments, and modeling to identify improvement opportunities. • Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability. • Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations. • Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies. • Lead commissioning, qualification, and startup of process equipment and automated systems. • Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks. • Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff. • Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites. • Ensure process consistency, scalability, and alignment with quality system expectations during transfer. • Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation. • Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings. • Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness. • Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans. • Manage vendor relationships, equipment upgrades, and external technical partnerships. • Mentor and support junior engineers, providing technical coaching and oversight.
Job Requirements
- BS or MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred.
- 7–11 years of process engineering experience within biotech, pharmaceutical, or advanced manufacturing environments.
- Extensive hands-on experience with automated process equipment such as bioreactors, chromatography systems, filtration skids, or formulation systems.
- Strong familiarity with process automation platforms such as DeltaV, Rockwell, Siemens, or SCADA and PLC systems.
- Proven experience leading process development, scale-up, equipment integration, and optimization initiatives.
- Demonstrated ability to lead cross-functional teams and mentor junior staff.
Benefits
- market competitive base salary
- annual incentive plan
- robust benefit offerings
- generous flexible paid time off program
- company paid holidays
- flexible working hours
- fully remote work options
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