Process Engineer

Job Responsibilities

• Develop and review PFDs, P&IDs, GA layouts, and equipment specifications in collaboration with A/E and EPC teams.
• Lead commissioning and qualification (CQV) activities for sterile injectable systems including formulation, aseptic filling, isolators, CIP/SIP systems, and packaging lines.
• Execute FAT, SAT, IQ/OQ/PQ protocols in compliance with cGMP, FDA, and EMA standards.
• Troubleshoot technical issues during commissioning and provide on-site support for installation and system integration.
• Oversee punch-list resolution and drive continuous improvement initiatives using Lean and Six Sigma methodologies.
• Support procurement and vendor coordination for equipment delivery and installation.
• Prepare and manage CQV documentation, including SOPs, batch records, validation protocols, and change control.
• Interface with cross-functional teams including QA, validation, HSE, maintenance, utilities, and manufacturing.
• Provide technical guidance, staff training, and support formal handovers to operational teams.
• Utilize data management tools and performance metrics to analyze trends and improve system efficiency.

Qualifications

• Bachelor’s degree or higher in Chemical, Mechanical, Bioengineering, or related engineering/scientific field.
• 3–5+ years of experience in commissioning, CQV, or process/project engineering within biopharmaceutical, pharmaceutical, CDMO, or other GxP-regulated environments.
• Strong understanding of PFDs, P&IDs, GA layouts, equipment specs, and process features.
• Proven experience with commissioning and validation of sterile/aseptic systems.
• Familiarity with FDA/EMA GMP, ISPE guidelines, ASTM standards, and ISO regulations.
• Proficient in Lean Manufacturing, Six Sigma, TPM, and continuous improvement methodologies.
• Strong analytical, problem-solving, and communication skills with a risk-based thinking approach.
• Practical knowledge of electro-mechanical systems and HSE/Quality Management Systems.
• Skilled in data analysis, document management, and use of ERP and industry-specific IT tools.