Process Engineer - Drug Product
Precigen
June 25, 2026
On-site
Germantown, MD
$90,000 - $110,000 USD yearly
Operations
DUTIES AND RESPONSIBILITIES:
- Provide end-to-end technical support for gene therapy product manufacturing (Drug Product Fill Finish) at CMOs.
- Perform onsite Person-In-Plant activities at CMO DP Fill Finish locations.
- Coordinate cross-functionally with Process Development, CMO, Quality Assurance, Quality Control, Supply Chain, and Validation to transfer, implement, and maintain processes across multiple facilities.
- Provide on-the-floor technical oversight during product campaign startup and for DP Fill Finish process/equipment troubleshooting.
- Collect and trend process data; perform process capability assessments; identify continuous improvement opportunities.
- Author and/or review technical reports, tech transfer summary reports, risk assessments, master batch records, equipment user requirement specifications, and protocols supporting tech transfer, cGMP activities, and regulatory filings.
- Support investigations; identify root cause and corrective actions for production issues.
- Lead/support process improvement projects, including new DP Fill Finish technologies.
- Serve as subject matter expert for reviewing project plans, technical reports/studies, regulatory submissions, and Validation protocols at CMO.
QUALIFICATIONS:
- B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or another relevant engineering/scientific field (level based on education/experience).
- 3–4 years’ experience in biopharmaceutical manufacturing implementing process changes/optimization, technology transfer, and manufacturing support.
- Plus: experience with DP Fill Finish process development/scale-up; JMP statistical software; JMP/Excel data trending/management and statistical analysis; summarizing/presenting data; authoring technical reports.
- Plus: knowledge/experience with viral vectors and/or viral vaccines; Operational Excellence (OE) methodologies.
SKILLS/COMPETENCIES:
- Strong drug product manufacturing technical/scientific knowledge; critical thinking and quantitative problem-solving.
- Meticulous attention to detail; strong interpersonal and verbal/written communication.
- Maintain high ethical standards; open mindset; ability to mentor/coach.
- Physical requirements: lift/carry/push/pull up to 40 lbs; may work with hazardous materials; stand up to 4 hours at a time.
APPLICATION INSTRUCTIONS:
- Not provided.
- Provide end-to-end technical support for gene therapy product manufacturing (Drug Product Fill Finish) at CMOs.
- Perform onsite Person-In-Plant activities at CMO DP Fill Finish locations.
- Coordinate cross-functionally with Process Development, CMO, Quality Assurance, Quality Control, Supply Chain, and Validation to transfer, implement, and maintain processes across multiple facilities.
- Provide on-the-floor technical oversight during product campaign startup and for DP Fill Finish process/equipment troubleshooting.
- Collect and trend process data; perform process capability assessments; identify continuous improvement opportunities.
- Author and/or review technical reports, tech transfer summary reports, risk assessments, master batch records, equipment user requirement specifications, and protocols supporting tech transfer, cGMP activities, and regulatory filings.
- Support investigations; identify root cause and corrective actions for production issues.
- Lead/support process improvement projects, including new DP Fill Finish technologies.
- Serve as subject matter expert for reviewing project plans, technical reports/studies, regulatory submissions, and Validation protocols at CMO.
QUALIFICATIONS:
- B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or another relevant engineering/scientific field (level based on education/experience).
- 3–4 years’ experience in biopharmaceutical manufacturing implementing process changes/optimization, technology transfer, and manufacturing support.
- Plus: experience with DP Fill Finish process development/scale-up; JMP statistical software; JMP/Excel data trending/management and statistical analysis; summarizing/presenting data; authoring technical reports.
- Plus: knowledge/experience with viral vectors and/or viral vaccines; Operational Excellence (OE) methodologies.
SKILLS/COMPETENCIES:
- Strong drug product manufacturing technical/scientific knowledge; critical thinking and quantitative problem-solving.
- Meticulous attention to detail; strong interpersonal and verbal/written communication.
- Maintain high ethical standards; open mindset; ability to mentor/coach.
- Physical requirements: lift/carry/push/pull up to 40 lbs; may work with hazardous materials; stand up to 4 hours at a time.
APPLICATION INSTRUCTIONS:
- Not provided.