Senior Validation Engineer



Local candidates.. must be onsite. Contract to hire opportunity:

• Provides 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 updates

• Owns 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).

• Other related job duties as assigned.

Qualifications:

• 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.