Sr Process Engineering - MSAT

About This Role

Manage the process technology platform strategy for biotherapeutics production, focusing on process and cleaning validation, equipment standardization, and process analytics. Support manufacturing operations and lead process improvement initiatives to ensure compliance with US and EU regulations.

Responsibilities

• Engage with the MSAT team to deliver successful outcomes for tech transfer activities and process analytics implementation using Good Manufacturing Practices (GMP)
• Perform tech transfer of new/commercial products and implement new technologies and/or digital tools
• Plan, document, and perform process validation studies
• Coordinate and execute MSAT process lifecycle management activities for new equipment, processes, and site startup initiatives
• Coordinate and execute process improvement projects, commercial product scale-up initiatives, and technical transfer activities
• Provide second-line support to Manufacturing Operations and technical guidance for process improvement projects and investigations
• Track and resolve exceptions/events/nonconformances during MSAT activities
• Coordinate and prioritize MSAT activities in alignment with manufacturing and project schedules
• Implement, qualify, and maintain PAT tools to enable real-time monitoring of CQAs and CPPs
• Integrate PAT instrumentation with manufacturing data systems to support process control and continuous verification
• Analyze process data to identify trends, deviations, and sources of variability across biologics manufacturing operations
• Conduct statistical modeling, multivariate analysis, and batch trajectory analytics to support investigations and continuous improvement
• Support model lifecycle activities including development, validation, documentation, and ongoing performance monitoring in a GMP environment
• Author basic modeling-related documents including model development reports and analysis summaries
• Prepare, review, and approve technical documents, CAPAs, change control requests, investigations, protocols, reports, and SOPs
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports

Requirements

• Minimum 7 years of experience in pharmaceutical manufacturing or regulated industry (or 4+ years with advanced degree)
• Minimum 2 years of experience in Technical Transfer process
• Experience with process analytics, modeling
• Proven knowledge and application of industry regulations including FDA, EMEA, and other authorities
• Ability to collect, process, and analyze data for informed decisions
• Excellent verbal and written communication skills
• Excellent computer proficiency e.g MS Office, Excel, SAP
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests
• Adaptable and flexible with great problem-solving skills
• Ability to work independently with minimum supervision, with good sense of prioritization and time management

Qualifications

• A minimum bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field
• A minimum of 7 years of experience in the pharmaceutical manufacturing industry or regulated industry experience or 4+ years with advanced degree

Nice to Have

• Supporting New Product Introduction/process validation
• Ability to lead multi-functional teams and to manage complexity and change

Skills

* Required skills