Job Title: Manufacturing Process Engineer – Oral Solid Dosage (OSD)
Location: NC & MA
Experience: 10+ Years
Contract Duration: 12+ Months (possible extension)
Job Overview
This senior-level process engineer will own the design, scale‑up, validation, and continuous improvement of tablet and capsule manufacturing for Oral Solid Dosage products. The role ensures process robustness, compliance with global regulatory standards (cGMP, FDA, EMA, WHO, ICH), and drives Lean‑Six Sigma initiatives in commercial operations.
Key Responsibilities
- Lead end‑to‑end process development, optimization, and scale‑up for OSD products including tablets, capsules, and pellets.
- Design, evaluate, and optimize granulation, blending, compression, coating, and encapsulation processes.
- Perform process characterization, DOE studies, and statistical data analysis to define and control critical process parameters.
- Author, review, and maintain Master Batch Records, SOPs, and manufacturing instructions.
- Support technology transfer from R&D to pilot and commercial manufacturing.
- Investigate manufacturing deviations, yield losses, and OOS/OOT events using structured root cause analysis.
- Lead and execute process validation activities including IQ, OQ, PQ, and PPQ.
- Ensure compliance with cGMP and global regulatory standards (FDA, EMA, WHO, ICH).
- Drive continuous improvement initiatives using Lean, Six Sigma, and Kaizen methodologies.
- Collaborate with QA, QC, Regulatory Affairs, Production, and Supply Chain teams.
- Support regulatory inspections and customer audits through technical documentation and process expertise.
- Evaluate, qualify, and implement new manufacturing equipment and process technologies.
- Monitor and improve KPIs related to productivity, yield, efficiency, quality, and cycle time.
- Provide technical mentorship and guidance to junior engineers.
- Identify and execute cost‑reduction and process robustness initiatives without compromising product quality.
Equipment and Technologies
- High‑shear granulators
- Fluid Bed Processors
- Bin blenders and V‑blenders
- Tablet compression machines
- Capsule filling equipment
- Coating systems
- PAT tools and automated manufacturing systems
- PLC and SCADA‑controlled equipment
- Containment systems and potent compound handling (preferred)
Required Qualifications
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline.
- 10+ years of hands‑on experience in OSD pharmaceutical manufacturing.
- Strong knowledge of cGMP and FDA 21 CFR Parts 210 and 211.
- In‑depth understanding of ICH Q8, Q9, Q10, and EU GMP requirements.
- Proven experience with process validation, technology transfer, and regulatory compliance.
- Strong analytical, troubleshooting, and technical documentation skills.
- Ability to work effectively in cross‑functional teams.
Preferred Qualifications
- Six Sigma Green Belt or Black Belt certification.
- Experience supporting USFDA, MHRA, and EMA inspections.
- Knowledge of data integrity, serialization, and Annex 11 compliance.
- Hands‑on experience with SAP and MES systems.
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