Process Engineer (MS&T) -233

We are looking for a highly motivated Process Engineer to join our MS&T team and take full ownership of the process lifecycle—from technology transfer through commercial manufacturing.

This role combines deep process understanding with hands-on engineering execution, ensuring manufacturing processes are scalable, robust, compliant, and continuously improving. The ideal candidate will play a key role in bridging development, engineering, and manufacturing.

Key Responsibilities

Process Ownership & Technology Transfer

• Lead end-to-end technology transfer activities from development to manufacturing sites (internal and external)
• Drive process understanding using QbD principles, including risk assessments and definition of CPPs and CQAs
• Develop and execute scale-up strategies
• Author and own all tech transfer documentation (protocols, reports, gap analyses)
• Ensure effective knowledge transfer across lifecycle stages (Development → Clinical → Commercial)

Process Engineering & Manufacturing Support

• Act as process owner for commercial manufacturing processes
• Monitor process performance (CPV), perform data trending and statistical analysis
• Identify, lead, and implement continuous process improvements
• Define and maintain control strategies, including parameter ranges and in-process controls
• Provide hands-on support on the manufacturing floor during critical operations, deviations, and troubleshooting

Engineering Integration

• Serve as the primary MS&T interface with Engineering teams
• Align process requirements with equipment design, including URS, FAT/SAT, commissioning, and qualification
• Collaborate with internal teams and external vendors/CMOs to ensure successful project delivery
• Translate process needs into practical engineering solutions
• Support optimization of key unit operations such as UF systems, lyophilization, and aseptic fill-finish

Compliance

• Ensure all activities meet cGMP standards and regulatory requirements (FDA, EMA, ICH)
• Maintain inspection readiness at all times

Qualifications

Education

• B.Sc., M.Sc., or PhD in Chemical / Biochemical / Mechanical Engineering or related field

Experience

• Minimum of 7 years of experience in aseptic pharmaceutical / biopharmaceutical manufacturing
• Proven experience in process engineering within regulated environments
• Hands-on experience leading technology transfer processes
• Experience managing complex engineering projects

Skills & Expertise

• Strong expertise in biopharmaceutical manufacturing processes and equipment (e.g., lyophilization, UF, isolators, fill & finish)
• Experience in process development, scale-up, validation, and optimization
• Deep understanding of cGMP and global regulatory requirements
• Familiarity with advanced manufacturing technologies (automation, PAT, digital manufacturing)
• Strong cross-functional collaboration and communication skills
• Analytical thinker with a hands-on, problem-solving approach