Senior Manufacturing Engineer
4 weeks ago
Senior Manufacturing Engineer
Location: Onsite role in Thousand Oaks, CA
Pay Range: 40-46$ per hour
Application: Please attach a resume highlighting relevant engineering experience in a pharmaceutical manufacturing environment.
Role Overview: We are seeking a dedicated Senior Engineer to support our cGMP equipment and facilities operations. The ideal candidate will possess a strong technical background in engineering, with hands-on experience in the pharmaceutical, chemical, or related industries. This role is pivotal in ensuring the seamless operation and reliability of our cell culture equipment while upholding the highest safety and quality compliance standards.
Key Responsibilities:
- Collaborate with cross-functional teams to develop and manage equipment operations.
- Lead capital projects and contribute data for business cases and strategic planning.
- Identify and implement critical quality parameters and process attributes for equipment and facility enhancements.
- Design and execute commissioning strategies, ensuring equipment validation aligns with regulatory standards.
- Manage contract resources and oversee verification deliverables.
- Serve as the engineering liaison with quality assurance throughout project lifecycles.
- Uphold safety practices and maintain documentation in compliance with cGMP standards.
- Drive continuous improvement in commissioning processes, maintenance practices, and productivity.
Related Activities:
- Lead or participate in multidisciplinary site teams for root cause analysis and process improvement.
- Support Lean Transformation initiatives to enhance operational efficiency.
- Provide technical support and mentorship to manufacturing and maintenance teams.
- Advocate for equipment-specific calibration, maintenance, and validation during regulatory inspections.
Pre-Screening Questions:
- Describe a challenging equipment repair you’ve performed in a manufacturing or home setting.
- Recall a situation where things didn’t go as planned. What was the issue and how did you resolve it?
- Share an instance where you took the initiative to improve an equipment or business process.
Feedback from Management: We are looking for candidates with robust, hands-on engineering experience, capable of practical troubleshooting and engaging in technical discussions. The ideal candidate should have a solid foundation in the technical and mathematical aspects of engineering, rather than laboratory or benchtop science work. Preferred backgrounds include drug substance production, pharmaceuticals, chemical processing, oil refinery, or mechanical engineering.
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