Junior Process Validation Specialist

Junior Process Validation (Bioprocess Validation Associate)

Location: Fremont, CA

Work Model: Onsite

Contract: 8 months

Work Schedule: Mon-Fri, 8:00AM-5:00PM

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.