TS/MS Engineer – Cleaning Validation/Sterilization Validation

Role Summary

The Principal Scientist/Engineer – Cleaning Validation/Sterilization Validation – Technical Services / Manufacturing Science (TS/MS) role develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include start-up and compliant manufacturing, development and implementation of validation strategies (sterilization, cleaning, filter validation), and support for device assembly, packaging, and syringe filling operations targeted for transfer to the Concord site.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including interactions among chemistry, equipment, aseptic processes, and container closure systems.
• Provide technical support for start-up activities related to temperature mapping, cleaning and sterilization programs.
• Develop and execute cleaning and sterilization strategies that validate production equipment and systems (e.g., tanks, washers, autoclaves, filling isolators).
• Support periodic requalification activities for production equipment and systems.
• Author and support the execution of validation protocols and reports.
• Provide technical guidance to the Process Team for cleaning and sterilization processes.
• Lead or provide technical support for root cause investigations related to cleaning, sterilization, and related activities.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Coordinate with cross-functional process teams to implement projects to improve productivity, quality, or continuous improvement of cleaning and sterilization processes.
• Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for preparation of technical documents such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Support and/or lead TS/MS technical projects to ensure successful start-up, improve process control, yield, product quality and/or productivity; implement process changes through the technical agenda.
• Serve as cleaning and sterilization interface external to the Concord site.
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and product supply chain.
• Ensure a safe working environment through compliance with safety rules and actively participate in safety-related activities.

Qualifications

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• 3+ years of experience supporting cGMP manufacturing (validation, engineering, technical services/MSAT, operations, quality assurance, etc.)

Additional Preferences

• In-depth knowledge of parenteral drug product manufacturing
• Experience executing equipment qualification, cleaning validation, and sterilization validation
• Demonstrated successful leadership of cross-functional teams
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems

Other Information

• Role is Monday through Friday based.
• Must be flexible to accommodate other inputs (production schedules, shutdowns).
• Occasional extended hours and/or off-hour work may be required.
• Position based in Concord with ability to travel to Indianapolis and other Lilly sites as required.