Job Title: Senior Engineer
Location: Thousand Oaks, CA (Onsite)
We are seeking a highly skilled and experienced Senior Engineer to join their dynamic team at their Thousand Oaks, CA location. This role offers an exceptional opportunity to contribute to the company’s mission of delivering high-quality products and services.
Key Responsibilities:
- Provide comprehensive, hands-on engineering support for a variety of manufacturing activities, specifically those related to current Good Manufacturing Practices (cGMP) equipment and facilities at our client’s location.
- Assume responsibility for the reliability of manufacturing equipment and the successful delivery of key capital projects.
- Assist in the identification of critical quality parameters and process attributes for new equipment or modifications to existing facilities.
- Propose design modifications to mitigate risks, enhance quality, and promote safety.
- Develop strategic commissioning plans based on the User Requirement Specification (URS) and Quality Risk Assessment for Automation and Equipment Systems (QRAES).
- Serve as a liaison between the engineering and quality assurance departments during project planning, execution, and closeout phases.
Required Skills and Qualifications:
- Extensive engineering experience with a strong background in the technical and mathematical aspects of the field.
- Practical troubleshooting skills and the ability to engage in technical discussions.
- Prior experience in regulated environments, including but not limited to FDA, OSHA, EPA, etc.
- Comprehensive knowledge of cGMP procedures and engineering practices related to pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment.
- Experience with risk-based verification on major GMP process equipment/automation projects.
- Exceptional communication skills and technical writing abilities.
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.