Engineering Specialist
9880 Campus Point Drive San Diego, CA 92121 US
Job Description
Responsibilities
- 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.
- 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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