Engineer Senior #JN -062021-65162
Thousand Oaks, California
Posted on: June 7, 2021
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -062021-65162
- The Sr. Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical supply organization. The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Thousand Oaks site.
- Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
- Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
- Monitor systems to identify performance risks and implement risk reduction strategies.
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
- Up to 10% domestic/international travel
- Doctorate degree OR
- Master’s degree and 3 years of Engineering experience OR
- Bachelor’s degree and 5 years of Engineering experience OR
- Associate’s degree and 10 years of Engineering experience OR
- High school diploma / GED and 12 years of Engineering experience
- Master’s degree in Chemical or Mechanical Engineering
- 6+ years' of relevant work experience with 3+ years' experience in Biopharmaceutical operations/manufacturing environment
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
- Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
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