Senior Process Engineer
Syner-G BioPharma Group
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $125,000 - $188,000 per year
Job Level
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
cell therapygene transductioncell expansioncryopreservationprocess control strategiesdata trendingprocess performance assessmentstechnical project executionprocess automationtechnical transfer
Soft Skills
leadershipmentoringtechnical guidanceissue resolutioncross-functional collaborationcoaching