Senior Process Engineer, MSAT External Manufacturing

About the role

The Senior Process Engineer, MSAT External Manufacturing (EM), is responsible for providing technical leadership and process support for the manufacture of intermediates and Active Pharmaceutical Ingredients (API) at external manufacturing sites. This role monitors process performance and drives improvements in cycle time, yield, quality, and operational efficiency. The position also supports the introduction and validation of new and existing products, resolves sophisticated manufacturing challenges, and provides technical expertise during regulatory inspections and other compliance-related activities.

Responsibilities

• Support lifecycle management activities for external sites, including technical assessments, onboarding, due diligence, fit-for-purpose evaluations, and ongoing engagement with CMOs aligned to MSAT product strategies and innovation initiatives.
• Cook up technology transfer activities, including strategy development, product introduction assessments, characterization studies, PPQ execution, data analysis with SMEs, and implementation of technical evaluations and change controls.
• Contribute to product lifecycle management activities, including CPV programs, criticality analysis, and APR/APQR reviews to maintain technical performance and compliance.
• Maintain site lifecycle management documentation, including account plans, technical risk segmentation, and proactive assessments such as cleaning validation and cross-contamination evaluations.
• Provide technical support for base business operations by contributing to complex investigations (e.g., deviations, OOT/OOS, complaints, CAPAs), material changes, qualifications, supply continuity efforts, and audit or inspection readiness.
• Partner with TLI and R&D on tech transfers, scale-up activities, manufacturing plans, and review of key technical documentation.
• Support new product introductions and line extensions by contributing to manufacturing process excellence through capability assessments, de-risking activities, and continuous improvements in cost, yield, cycle time, capacity, and technology.
• Contribute to manufacturing process excellence through capability assessments, de-risking activities, and continuous improvements in cost, yield, cycle time, capacity, and technology.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.

Qualifications

• Education: Bachelor’s degree is required.
• Experience and skills: Minimum of 4 years of proven experience in Manufacturing, MSAT, process science, or technical operations within the pharmaceutical or related industry.
• Apply strong knowledge of process science, validation, and lifecycle activities, including CPV, APR/APQR, investigations, and CAPA.
• Work independently and collaboratively to deliver results in cross-functional team environments.
• Contribute to technology transfers, process improvements, and manufacturing optimization initiatives.
• Lead or support complex nonconformance investigations using structured problem-solving and root cause analysis.
• Communicate clearly and collaborate effectively with collaborators across global, cross-functional teams.

Preferred

• Agile Manufacturing
• Business Valuations
• Chemistry, Manufacturing, and Control (CMC)
• Consulting
• Controls Compliance
• Developing Others
• Good Automated Manufacturing Practice (GAMP)
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO 9001
• Leadership
• Plant Operations
• Process Control
• Process Improvements
• Quality Management Systems (QMS)
• Quality Standards
• Quality Systems Documentation
• Standard Operating Procedure (SOP)
• Team Management
• Time Management