ACL Digital
Job Title: CW - Sr Engineer
Position/Role Title: Engineering
Fully onsite - Thousand Oaks, CA
Ideal Candidate: B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.
Job Summary:
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.
The Sr Engineer will: • 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 Client 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. 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, 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) Preferred Qualifications / Skills / Experience • 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
Ideal Candidate: B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.
Job Summary:
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.
The Sr Engineer will: • 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 Client 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. 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, 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) Preferred Qualifications / Skills / Experience • 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