Job Title : Senior Manufacturing Engineer
Location : Fully onsite at Thousand Oaks, CA
Manager’s Feedback :
- Looking for a hands-on engineer with strong technical and mathematical skills.
- Not looking for lab or bench work.
- Must be practical with troubleshooting and able to hold technical conversations.
- Relevant backgrounds : Drug substance, pharma, chemical, oil refinery, mechanical.
Job Overview : This role supports manufacturing activities. The Senior Engineer will work with various teams to ensure equipment operates reliably and safely, while meeting quality standards.
The role involves supporting projects, improving processes, and providing technical support.
Key Responsibilities :
- Lead by example and promote a positive work environment.
- Ensure equipment reliability and meet project goals. (Equipment Including : Bioreactors and Fermenters, Centrifuges, Pumps and Compressors, Heat Exchangers, PLC, HVAC Systems, Mixers and Blenders, Filtration Systems)
- Identify and improve quality parameters for new equipment.
- Suggest design changes to enhance quality and safety.
- Develop and oversee equipment validation strategies.
- Manage and evaluate contract resources.
- Liaise between engineering and quality assurance.
- Ensure safety compliance and proper documentation.
- Review and approve reports and maintenance practices.
Additional Activities :
- Lead or participate in cross-functional teams.
- Support process improvements to reduce costs and improve safety / quality.
- Provide technical support for manufacturing and maintenance.
- Coach and guide project teams using risk-based approaches.
- Defend equipment calibration and validation during inspections.
- Participate in internal audits.
- Help develop and maintain business performance metrics.
Basic Qualifications :
Doctorate, Master’s, Bachelor’s, Associate’s degree, or High school diploma / GED with relevant years of experience in engineering or manufacturing.
Preferred Qualifications :
- Bachelor’s degree in engineering or a science-related field.
- 7+ years of relevant work experience, with 5+ years in operations / manufacturing.
- Experience with regulated environments (FDA, OSHA, EPA).
- Knowledge of cGMP procedures and engineering practices.
- Experience with risk-based verification and validation.
- Strong communication and technical writing skills.
- Team player with a collaborative mindset.
- Experience with process improvement methodologies (e.g., PDCA, LEAN, Six Sigma).
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