Senior Process Engineer – OSD

Job Title: Senior Process Engineer – OSD

Location: NC & MA

Experience: 10+ Years

Contract Duration: 12+ Months (possible extension)

Job Overview

This role requires a senior-level process engineer with strong, hands-on expertise in Oral Solid Dosage manufacturing. The position owns process design, scale-up, validation, and optimization for tablet and capsule manufacturing, with direct responsibility for process robustness, compliance, and continuous improvement 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 including FDA, EMA, WHO, and 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