Analytical Engineer

Thousand Oaks, California

Job Title: Analytical Engineer

Location: Thousand Oaks, CA (Onsite)

Pay Rate: $37/hr – $41/hr

Responsibilities:  

  • Be individually accountable for the verification deliverables on key capital projects.
  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Oversee development of validation protocols in line with CQP and cGMP standards.
  • Lead, evaluate, and manage performance of contract resources.
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
  • Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.

 
Required Skills:  

  • Bachelor’s degree in engineering or another science-related field
  • 2+ years of relevant work experience in 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
  • Demonstrated strong communication and technical writing skills
  • Strengths in facilitation and collaboration / networking with cross-functional groups
  • Experience in developing SOPs and delivering training

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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