Process Engineer

1 month ago

Thousand Oaks, United States EPITEC Full time

*Looking for Engineer experience in a pharma manufacturing setting*

Not looking for quality lab/ bench top/ science work.


This engineering position supports manufacturing activities associated with cGMP equipment and facilities. The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.



• Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.

• Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables

• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

• Suggest design modifications to address risks and design in quality and safety.

• 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).

• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.

• Recommend, evaluate, and manage performance of contract resources

• Provide oversight for verification deliverables developed by outsourced/contract verification staff.

• Act as a liaison between engineering and quality assurance during project planning, execution, and closeout

• Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

• Review and approve the commissioning reports, maintenance practices and parts, and drive productivity improvement


Resumes need to have a strong level of detail that documents the job seekers experience. Job seekers must be able to speak to the experience listed in interview


***Must have engineering degree***

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