Process Engineer

About the Job

We are seeking an experienced Process Engineer to support both Oral Solid Dosage (OSD) and Sterile manufacturing operations. This role focuses on process validation, continuous process verification (CPV), equipment qualification, investigations, operational excellence, and process improvements in a GMP-regulated pharmaceutical environment.

• Lead process investigations, root cause analysis (RCA), CAPA, and risk assessments (FMEA/HACCP).
• Develop and maintain CPV programs, monitor CPPs/CQAs, and support process optimization.
• Execute IQ/OQ/PQ, process validation, technology transfer, and equipment lifecycle activities.
• Support Operational Excellence initiatives using Lean, Six Sigma, and reliability engineering principles.
• Manage serialization and aggregation projects for OSD packaging operations.
• Support aseptic manufacturing, media fills, environmental monitoring, and qualification of filling lines, autoclaves, isolators, and lyophilizers.
• Collaborate with Engineering, Manufacturing, QA, Maintenance, and Validation teams to ensure GMP compliance.

• Bachelor's or Master's degree in Engineering or related discipline.
• 5–10 years of pharmaceutical manufacturing experience in OSD and Sterile environments.
• Strong experience with process validation, CPV, IQ/OQ/PQ, CAPA, RCA, and regulatory audits.
• Knowledge of cGMP, FDA/EMA regulations, Annex 1, Serialization, and reliability engineering.
• Lean Six Sigma, CRE, or PMP certification is a plus.