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JUNIOR Process Validation

Fremont, CA 94555

Posted: 03/17/2025 Employment Type: Contract Job Category: Engineering Job Number: 618427 Is job remote?: No Country: United States

Job Description


Duties:    
Candidate will work with MSAT Process Validation group with the following responsibilities:
  • Responsible for performing data mapping of Continued Process Verification (CPV) software.
  • Assist in the development and implementation of CPV data mapping strategies.
  • Collect, organize, and map process data and QC data from various sources to ensure accurate and comprehensive data sets.
  • Perform CPV evaluation and generate CPV reports.
  • Generate new work instruction and curriculum to implement new CPV software.
  • Maintain accurate and up-to-date documentation of CPV activities and data mappings.
  • Support other process validation projects (as needed) to ensure processes are validated to required standards. 
  • Reviews and interprets data for accuracy for completed validations/re-validations and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
  • Manage all moderate troubleshooting efforts for protocol discrepancies.

Skills:    
  • Basic understanding of GMP (Good Manufacturing Practices) and regulatory guidelines.
  • Proficiency in Microsoft Office including Word, Excel, and Visio.
  • Experience with Minitab or similar statistic analysis software is preferred
  • Process validation background is preferred. 
  • Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes is preferred.
  • Excellent technical writing and verbal communication skills
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a team environment.
  • Demonstrate ability to manage multiple activities while maintaining a high level of organization.
  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.

Education:    
  • Required: Bachelor's Degree.

Certifications & Licenses:    
  • Proficiency in Microsoft Office including Word, Excel, and Visio




Pay Rate Range: $25-34/hr depending on experience 

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 is an equal opportunity employer. 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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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

Although this hasn't been an issue at Planet Pharma, 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.