Process Engineer

Job Overview:
We are seeking a Process Engineer to support the design, construction, and commissioning of process systems within a new manufacturing facility. This role serves as a critical link between engineering design and operations, ensuring process systems are fully prepared for GMP production. The ideal candidate will bring expertise in process documentation, equipment installation, and CQV protocols while collaborating across multidisciplinary teams. This position offers the opportunity to make a significant impact on facility readiness and long-term operational success.

Job Responsibilities:

• Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process layouts, and equipment specifications in collaboration with A/E and EPC teams

• Ensure engineering deliverables are accurate and support contractor bidding and installation

• Lead commissioning and qualification activities for process equipment including mixers, isolators, filling lines, and CIP/SIP systems (FAT, SAT, IQ/OQ/PQ)

• Support procurement activities, coordinate with vendors, and resolve on-site installation challenges

• Collaborate with utilities, electrical, mechanical, instrumentation, QA/validation, and EH&S teams to achieve integrated design and execution

• Troubleshoot technical issues during commissioning and drive continuous improvement initiatives

• Prepare and execute CQV documentation, including SOPs, validation protocols, batch records, and change control files

• Oversee punch-list resolution and provide post-installation support to ensure operational readiness

• Manage formal handovers to manufacturing and maintenance teams, including staff training and technical guidance

Qualifications:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field

• Minimum 1 year of experience in process or project engineering within pharmaceutical, biotech, or CDMO facility construction and commissioning

• Proficiency in interpreting PFDs, P&IDs, GA layouts, and equipment specifications

• Hands-on experience with CQV activities (commissioning, IQ/OQ/PQ) for aseptic or sterile equipment

• Strong knowledge of FDA and EMA GMP, ISPE guidelines, ASTM standards, OSHA requirements, and risk management tools

• Familiarity with Lean, Six Sigma, or TPM methodologies