What are the responsibilities and job description for the Junior Process Validation Specialist position at Staffana?
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.
