Senior Engineer

Thousand Oaks, California

Innovate, Lead, Excel: Join our team as Senior Engineer!

Competitive Compensation: Up to $49/hr – Rewarding Excellence!

Location: Onsite at Thousand Oaks, CA

Are you an experienced engineer looking to make a significant impact in a dynamic and regulated environment? Join our team as a Senior Engineer and be a key player in supporting department and capital projects, ensuring the reliability of manufacturing equipment, and contributing to our long-term strategic goals.

Key Responsibilities

  • Ensure the reliability of manufacturing equipment and deliverables on key capital projects to meet business targets.
  • Identify critical quality parameters and process attributes for new equipment or facility modifications.
  • Suggest design changes to address risks and incorporate quality and safety.
  • Develop commissioning strategies based on URS and QRAES to validate equipment design while minimizing cost and schedule impacts.
  • Oversee the development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
  • Recommend, evaluate, and manage the performance of contract resources.
  • Ensure work is executed with safety-compliant practices and documented according to cGMP standards.
  • Lead or participate in multidisciplinary site teams, e.g., cross-functional teams, root cause analysis.

Required Qualifications

  • Bachelor’s degree in engineering or another science-related field.
  • 7+ years of relevant work experience, with 5+ years in an operations/manufacturing environment.
  • Direct experience with 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 of industry/regulatory trends for verification/validation.
  • Strong process equipment knowledge (cell culture, fermentation, purification, filling, and packaging).
  • Strong process automation knowledge, including automation infrastructure and project execution/verification.

Join our team and contribute to a culture of innovation, collaboration, and excellence!

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. 

 

 

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