Engineer Senior
- Thousand Oaks, CA
- Contract
- Full-time
Ideal Candidate: B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.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.Demonstrated Skills
- 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, BMS, 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)
- 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 company 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.
- Doctorate degree OR
- Masters degree and 2 years of experience OR
- Bachelors degree and 4 years of experience OR
- Associates degree and 8 years of experience OR
- High school diploma / GED and 10 years of experience
- Projects,
- Continuous Improvement and
- Analytical problem solving.
- 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