Syner-G
Process Engineer
- Confirmed live in the last 24 hours
- No salary listed
- Mid level
- On-site · Plainville, Massachusetts, United States
- 5+ yrs exp
- Added 2 months ago
About this role
Syner-G is seeking a Process Engineer to facilitate the transfer of manufacturing processes between development, clinical, and commercial facilities. This role involves evaluating technical readiness, mitigating risks, and ensuring successful implementation while collaborating with cross-functional teams and external partners. The ideal candidate will leverage their expertise in process engineering, technology transfer, and GMP manufacturing to ensure operational readiness and compliance.
What you'll do
- Lead technical gap assessments between manufacturing sites.
- Develop and implement technology transfer strategies for clinical and commercial programs.
- Define and monitor critical process parameters (CPPs) and quality attributes (CQAs).
- Support process characterization, troubleshooting, and risk assessments.
- Provide technical support during process qualification and manufacturing activities.
- Ensure compliance with GMP requirements and regulatory expectations.
What they're looking for
- Process Engineering
- Technology Transfer
- Single-Use Systems (SUS)
- Process Characterization
- Risk Management
- GMP Manufacturing
- Process Validation
Benefits
- Career growth and development opportunities
- Positive and engaging work environment
- Strategic biopharma product development
- Meaningful and varied work
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Syner-G
Likely interview questions
- Describe your experience leading technology transfer projects in a pharmaceutical or biotech setting.
- How do you identify and mitigate risks associated with process transfers?