Process Engineer – Pharmaceutical Manufacturing (Temp-to-Hire)
Oral Solid Dosage & Sterile Ops
About the Role
We are seeking a hands-on Process Engineer for a temp-to-hire opportunity supporting both Oral Solid Dosage (OSD) and Sterile (vials/syringes) manufacturing operations. This role is ideal for an engineer with strong equipment qualification and technology transfer experience who is ready to drive process robustness, compliance, and continuous improvement across a dynamic pharmaceutical manufacturing environment.
What You'll Do
- Plan, execute, and document Equipment Qualification (IQ/OQ/PQ) and process validation activities across OSD and sterile manufacturing.
- Lead technology transfer activities for new products, processes, and equipment introductions.
- Lead root cause investigations for deviations and OOT results, and develop effective CAPAs.
- Develop and maintain Continuous Process Verification (CPV) programs; monitor CPPs/CQAs.
- Support aseptic manufacturing processes for injectable products (syringes, vials, ampoules), including sterility assurance reviews and equipment qualification (autoclaves, filling lines, isolators, lyophilizers).
- Identify and execute process improvement, yield-improvement, and cost-reduction projects while maintaining compliance.
- Perform risk assessments (FMEA) and apply statistical/analytical tools for process monitoring.
- Partner cross-functionally with Engineering, Maintenance, and QA to keep systems in a qualified state.
What You Bring
- Bachelor's or Master's degree in Chemical, Mechanical, or Pharmaceutical Engineering (or related field)
- 5–10 years of pharmaceutical manufacturing experience, with demonstrated experience in OSD and exposure to Sterile(syringes/vials) operations
- Proven, hands-on experience with IQ/OQ/PQ and Technology Transfer
- Track record leading process improvement initiatives in a regulated pharma environment
- Experience with root cause investigation, CAPA management, and regulatory audits (FDA, EMA, MHRA)
- Working knowledge of cGMP, ICH Q8–Q10, Annex 1, and 21 CFR 210/211
- Strong analytical skills (Minitab, MS Project a plus)
Preferred
Lean Six Sigma Green/Black Belt
Certified Reliability Engineer (CRE)
PMP
Position Details
Position Type: Temp-to-Hire
Work Setting: On-site/Plant-based, with occasional off-shift or weekend support as needed.
Job Types: Full-time, Temporary
Pay: $42.00 per hour
Work Location: In person
