Job DescriptionPurpose:
The Senior Technical Expert - Aseptic Equipment & Sterile Processing serves as a global subject matter expert responsible for the design, technology selection, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment across pharmaceutical and biologics facilities. This role provides deep expertise in sterile manufacturing technologies including aseptic filling lines, isolators, barrier systems, sterilization systems, and supporting equipment. The position supports global capital projects and operational sites by ensuring equipment design and performance meet regulatory expectations, corporate engineering standards, and operational reliability requirements. The incumbent shall ensure alignment with EU GMP Annex 1 requirements, sterility assurance principles, and contamination control strategies across equipment design and operational practices. The Technical Expert also provides leadership in troubleshooting complex aseptic equipment issues, evaluating emerging technologies, and supporting successful startup and qualification of sterile manufacturing systems. As the expert in technology, this role requires leadership in adoption of best-in-class technology and engineering practices. to drive transformational performance through accelerated timelines taking advantage of digital technologies, adoption of best-in-class technologies ensuring that the design will deliver a safe, reliable, maintainable best-in-class operation. This position supports multiple strategic projects and ensuring cross-functional alignment and communication in a matrix organization with project leads along with other Operations and external functions is key to success. The incumbent will report to Director, Engineering in the Operations Transformation organization.
Responsibilities:- Serve as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies and provide technical leadership in the design, specification, and lifecycle management of aseptic equipment.
- Support global capital projects and manufacturing sites with expert guidance on aseptic processing technologies.
- Establish and maintain engineering standards and best practices for sterile manufacturing equipment and provide expert guidance to ensure equipment design and operational practices comply with EU GMP Annex 1: Manufacture of Sterile Medicinal Products.
- Support implementation of Contamination Control Strategies (CCS) across sterile manufacturing facilities by ensuring that equipment designs support robust sterility assurance principles including minimization of operator interventions, effective sterilization and decontamination processes
- Support contamination risk assessments and provide technical input during regulatory inspections and responses related to sterile manufacturing equipment.
- Lead technical evaluations and technology selection for aseptic manufacturing systems including Vial, syringe, and cartridge filling lines, isolators, Lyophilizers, autoclaves and sterilization systems, de-pyrogenation tunnels, CIP and SIP systems
- Conduct vendor technical assessments and due diligence.
- Support development of global equipment standards and technology roadmap and provide input to capital investment planning for sterile manufacturing technologies.
- Provide technical oversight during equipment design, procurement, and integration.
- Review vendor designs to ensure compliance with specifications and standards
- Provide technical leadership during commissioning, qualification, and startup of aseptic equipment.
- Review and approve equipment commissioning and qualification documentation including:
- FAT and SAT protocols, Commissioning plans, Installation Qualification (IQ) and Operational Qualification (OQ), support performance qualification readiness and GMP startup activities.
- Provide expert troubleshooting support for complex aseptic equipment and sterile manufacturing systems.
- Lead root cause investigations related to equipment performance issues, sterility risks, and contamination events.
- Support corrective and preventive action (CAPA) development and implementation.
- Provide technical support during critical production or startup events.
- Develop best practice guidance and technical standards for global engineering teams.
- Provide training and technical mentorship to engineering and manufacturing teams.
- Ensure consistency of engineering approaches across projects and sites
- Foster a culture of safety, accountability, collaboration, and operational excellence.
Qualifications- BS, Engineering or equivalent technical degree; Master's degree in Engineering preferred
- 10+ years of experience as a technical subject matter expert in aseptic and sterile fill operations
- Proven leadership experience in delivery of fill and finish projects from concept to qualification
- Deep knowledge of engineering systems in a drug product facility
- Familiarity with industry leaders in fill and finish equipment such as B&S, Syntegon, Groninger, Optima, Skan, EMA
- Demonstrated experience managing Engineering contractors and global equipment vendors
- Results-oriented leadership with outstanding negotiation skills and risk-based decision making is required
- Ability to mentor and develop next generation of leaders
- Travel to the US and Europe for design reviews/workshops/visits to vendor facilities/installation/ C&Q support will be required
Key Stakeholders: ME&C, PDS&T, R&D, Procurement, Global Engineering, EHS, Facilities, AI and Digital Transformation,
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
