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Associate Process Engineer

Novato, CA 94949

Posted: 06/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 554848 Is job remote?: No Country: United States

Job Description


ROLE

Manufacturing Sciences & Technology (MSAT) Frontline staff are technical and process stewards of commercial cGMP Manufacturing across multiple production platforms. MSAT Frontline staff are accountable for investigations and resolution of process-related deviations investigations. The team manages performance monitoring and process knowledge at the Novato site. Our Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain our cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

KEY RESPONSIBILITIES

PROCESS KNOWLEDGE:
  • Ability to apply technical knowledge of biopharmaceutical processes (cell culture, purification, etc.) and engineering experience to resolve process issues.
  • Support manufacturing process optimization and improvement.
  • Skill with performance monitoring tools and their application and interpretation.

TECHNICAL DOCUMENTATION:
  • Assist in the incorporation of new technologies, practices and standards into procedures
  • Capable of writing and reviewing process and workflow documents, including investigations, campaign technical reviews, APRs.
  • QUALITY AND COMPLIANCE:
  • Understanding of cGMPs as related to Clinical and Commercial Operations.
  • Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

BUSINESS:
  • Ability to participate on projects and contribute to outcomes.
  • Collaborate cross-functionally to meet the goal of planned and predictable delivery of product to patients
  • Other duties as assigned

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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