ACL Digital
Engineering Project Manager
Location:
Thousand Oaks, CA 91320
Type of Work:
Only on W2 basis
Job Summary:
The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at Client’s Thousand Oaks Office.
Responsibilities
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
Develop and present project charters/strategies to leadership.
Assist in development and review of User Requirements Specifications (URS).
Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
Partner with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk‑based approach).
Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
Ensure safety during commissioning, validation, maintenance and manufacturing activities.
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or other science‑related field.
8 or more years of relevant work experience in operations/manufacturing environment.
5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support).
Direct experience working within regulated environments (FDA, OSHA, EPA, etc.).
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment.
Experience implementing risk‑based verification on major GMP process equipment / automation projects, including validation protocol development and execution.
Understanding and awareness of industry/regulatory trends for verification/validation.
Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging.
Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus.
Demonstrated strong communication and technical writing skills.
Strengths in facilitation and collaboration / networking.
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Thousand Oaks, CA 91320
Type of Work:
Only on W2 basis
Job Summary:
The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at Client’s Thousand Oaks Office.
Responsibilities
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
Develop and present project charters/strategies to leadership.
Assist in development and review of User Requirements Specifications (URS).
Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
Partner with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk‑based approach).
Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
Ensure safety during commissioning, validation, maintenance and manufacturing activities.
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or other science‑related field.
8 or more years of relevant work experience in operations/manufacturing environment.
5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support).
Direct experience working within regulated environments (FDA, OSHA, EPA, etc.).
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment.
Experience implementing risk‑based verification on major GMP process equipment / automation projects, including validation protocol development and execution.
Understanding and awareness of industry/regulatory trends for verification/validation.
Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging.
Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus.
Demonstrated strong communication and technical writing skills.
Strengths in facilitation and collaboration / networking.
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