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Engineering Specialist

San Diego, CA 92121

Posted: 09/19/2023 Employment Type: Contract Job Category: Engineering Job Number: 569190 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $60-90/hr
  • 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.

  • 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 ways
  • Ability 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.
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