Junior Process Validation

7 days ago

Fremont, California, United States Meet Life Sciences Full time

This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $30.00/hr - $33.00/hr
Job Summary: We are seeking a motivated Junior Process Validation Specialist to join our team. This role will support the development and implementation of Continued Process Verification (CPV) strategies, ensuring the collection, organization, and mapping of process and quality control (QC) data. The ideal candidate will assist in generating CPV reports, creating new work instructions, and supporting process validation projects. You will play a key role in maintaining accurate documentation, troubleshooting protocol discrepancies, and working alongside cross-functional teams to ensure processes meet required standards.
Responsibilities:
Perform data mapping of Continued Process Verification (CPV) software to ensure data is accurately mapped and organized from various sources.
Assist in the development and implementation of CPV data mapping strategies.
Collect, organize, and map process and QC data, ensuring the integrity of data sets for CPV evaluations.
Conduct CPV evaluations and generate detailed CPV reports.
Create new work instructions and training materials to implement and support CPV software.
Maintain accurate and up-to-date documentation of CPV activities, including data mappings and reports.
Support other process validation projects as needed, ensuring processes meet required standards for validation and re-validation.
Review and interpret data for accuracy in completed validations/re-validations, preparing comprehensive reports to support test and protocol requirements.
Troubleshoot moderate protocol discrepancies, ensuring corrective actions are documented and communicated appropriately.
Qualifications:
Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Biopharmaceutical Sciences) is required.
Previous experience in process validation or biopharmaceutical manufacturing is preferred.
Familiarity with cell culture and purification manufacturing processes is a plus.
Experience with statistical analysis software such as Minitab is preferred.
Basic understanding of Good Manufacturing Practices (GMP) and regulatory guidelines.
Demonstrated ability to troubleshoot and resolve discrepancies in protocols or validation processes.
Seniority level Entry level
Employment type Contract
Job function Other
Industries Pharmaceutical Manufacturing

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