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Role Summary 

The Senior Manufacturing Engineer / Senior Process Engineer is responsible for the design, implementation, optimization, troubleshooting, and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical products. The role requires strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. This role plays a key technical role in maintaining sterility assurance, driving equipment reliability, supporting regulatory compliance (cGMP, EU Annex 1), and leading or significantly contributing to process improvements, automation enhancements, and validation activities in ISO 5/Grade A cleanroom environments. 

Key Responsibilities 

• Effectively manage and coordinate aseptic manufacturing technical processes and functions at the site in support of technical projects. 

• Lead or independently execute the design, modification, optimization, and qualification of aseptic process equipment and systems, including filling lines, isolators, RABS, autoclaves, CIP/SIP skids, formulation vessels, and clean utilities. 

• Develop and maintain detailed technical documentation including P&IDs, equipment specifications, 3D models, mechanical assemblies, and detailed fabrication drawings using SolidWorks, AutoCAD, or equivalent CAD platforms. 

• Troubleshoot and optimize automation systems including PLCs (Allen-Bradley, Siemens), HMIs, industrial networks, robotic material handling, vision inspection systems, and SCADA platforms used in aseptic filling and finishing. 

• Own or lead equipment installation, commissioning, qualification (IQ/OQ/PQ), process validation, cleaning validation, and media fill simulations for new installations, upgrades, or technology transfers. 

• Perform in-depth root cause analysis (RCA) on mechanical, automation, and process deviations; author and implement CAPAs; and drive permanent corrective solutions to improve yield, reduce downtime, and strengthen contamination control. 

• Serve as technical SME for aseptic equipment and automation during regulatory inspections, audits, and risk assessments (FMEA, HAZOP). 

• Lead or significantly contribute to change controls, process improvement projects, and capital projects aimed at enhancing sterility assurance, throughput, and operational efficiency. 

• Collaborate closely with Quality Assurance, Validation, Production, Maintenance, and Automation teams to ensure processes remain in a validated state and meet global regulatory expectations (FDA, EMA, ISO 14644, USP /, EU Annex 1). 

• Author, review, and approve SOPs, batch records, preventive maintenance plans, calibration procedures, and engineering protocols/reports. 

• Support cleanroom performance qualification activities including airflow visualization (smoke studies), particle monitoring, pressure cascade management, and personnel/material flow optimization. 

• Provide technical guidance and training to manufacturing and maintenance personnel on equipment operation, troubleshooting, and best practices. 

• Participate in off-shift, weekend, or on-call support during critical manufacturing campaigns, validation runs, or major investigations as required. 

Qualifications 

Education & Experience 

• Bachelor’s degree in mechanical engineering, Chemical Engineering, Biomedical Engineering, Electrical Engineering, or a closely related technical discipline required. 

• 5+ years of hands-on engineering experience in a cGMP-regulated pharmaceutical, biopharmaceutical, or sterile medical device manufacturing environment. 

• Demonstrated experience supporting or leading aseptic processing, sterile fill-finish, or cleanroom operations. 

Preferred Qualifications 

• Experience executing or leading process/equipment validation, media fills, and cleaning validation in aseptic environments. 

• Familiarity with data analytics tools (Excel, Minitab, JMP, OSIsoft PI) for process monitoring, capability analysis, and statistical evaluation. 

• Exposure to lean manufacturing, Six Sigma, or reliability-centered maintenance methodologies. 

• Previous involvement in capital project execution or technology transfer projects.