Senior Principal Engineer, Sterile Fill ב-AbbVie · Trevo

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.

דרישות

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 Information
Applicable 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.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html

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