HybridResponsibilitiesProvides engineering, validation and maintenance support to the decommissioning of QC equipment, facility and utilities at a site; equipment may include lab equipment such as cellometers, CX5, Densitometers, support systems such as SCADA, incubators, freezers bio-safety cabinets, offline bench-top instruments or facility/utility systems.Ensures equipment is decommissioned in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy.Manages exit calibration, periodic reviews, specification updatesOwns and manages changes to the lab equipment to maintain equipment in a validated state.Investigates any equipment or process deviations and developing corrective actions to prevent re-occurrences. Able to provide industry wide expertise for complex equipment and process investigations.Applies knowledge of engineering principles and best practices to ensure robust solutions.Provides mentorship to other process engineers.Leads small internal teams to help optimize engineering systems and processes.Obsoletes equipment specifications in standard documentation User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).QualificationsOther related job duties as assigned.B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.Excellent oral and written communication skills. Strong technical writing ability required.Working in a team environment, with excellent communication and organizational skills.Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.Demonstrated ability to lead cross functional teams across manufacturing locations in a fast pace, dynamic team setting.Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.Full understanding of area of specialization; resolves a wide range of issues in creative waysAbility to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Demonstrates good judgment in selecting methods and techniques for obtaining solutions.Networks with senior internal and external personnel in own area of expertise.
