Senior Pharmaceutical Manufacturing Engineer
- Thousand Oaks, CA
- Permanent
- Full-time
This role provides engineering support for projects and manufacturing activities, working in close collaboration with system owners, project teams, and cross-functional stakeholders. The Sr Engineer will leverage an engineering background to drive project implementation, continuous improvement initiatives, and system reliability. The role requires balancing technical problem-solving, project execution, and operational support, with a focus on compliance, safety, and business continuity.Responsibilities:
- Partner with system owners, maintenance, project management, and manufacturing to ensure reliable operation and execution of equipment and systems.
- Lead or support engineering-based improvements and capital projects, including requirements definition, design, construction, startup, and validation.
- Drive continuous improvement by applying Lean principles, Six Sigma, and other methodologies to reduce costs, improve quality/safety, and increase operational efficiency.
- Support commissioning, qualification, and performance verification activities for equipment and systems.
- Provide oversight into contractors and vendor deliverables and ensure adherence to *** standards.
- Act as liaison between Engineering and Manufacturing during project planning, execution, and closeout.
- Provide technical root cause analysis, troubleshooting, and problem-solving support to minimize downtime.
- Support new product/technology introductions through engineering assessments and equipment modifications.
- Ensure compliance with environmental health, safety, and regulatory requirements during all engineering activities.
- Deliver coaching and guidance to project teams on commissioning, qualification, and process risk-based approaches.
- This position requires onsite support with occasional flexibility to cover after-hours engineering needs in support of 24/7 operations.
- Ideal Candidate: B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.
- Bachelor’s degree in chemical, Mechanical, Electrical, or related Engineering field
- 6+ years of relevant engineering experience, with at least 5+ years in a biopharmaceutical or regulated manufacturing environment
- Experience working in compliance-driven settings (e.g., cGMP, OSHA, EPA)
- Direct knowledge of design, operation, and troubleshooting of GMP production equipment (e.g., chemical reactors, chillers, tablet press, dosage, clean utilities, etc.)
- Demonstrated ability to apply engineering principles to system modifications, process improvements, and capital project execution
- Knowledge of safety requirements and quality systems in a biopharmaceutical environment (change control, deviations, CAPA, validation)
- Proven ability to lead and collaborate within cross-functional project teams
- Strong leadership, technical writing, and presentation skills
- Independent, self-motivated, organized, and able to adapt to dynamic project environments
- Projects, Continuous Improvement and Analytical problem solving.
- Technical report writing, documentation, and presentations
- Strong verbal and written communication
- Organizational and changing management skills
- Analytical problem-solving and scientific/engineering reasoning
- Experience with systems such as Maximo, TrackWise, E-Builder, PCS, Client, and QEMS
- Ability to manage multiple projects and troubleshooting activities simultaneously
- Basic project management and cost estimation skills
- Conflict resolution and cross-functional collaboration
- Contractor and vendor management
- Development of SOPs and training delivery
- Customer service in a technical environment
- Continuous improvement methodologies (Lean, Six Sigma, SPC, Predictive Maintenance)
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