Summary

Responsible for supporting process validation (PV) activities at Genentech, Oceanside.

Deliverables include management of PV document schedule, facilitating document reviews and compliance checking.

Job Responsibilities

Assist with PV documentation:

• Manage document review workflows; ensure correct content, formatting and adherence to current PV templates
• Maintain timely communications with authors and document reviewers to ensure strict adherence to PV document schedule; update schedule as needed.
• Optimize document review process utilizing PV AppSheet and eVALRoche systems
• Compliance check PV reports to verify alignment with supporting data; includes best practices training with PV Ops.
• Coordinate with cross-functional teams:
• Collaborate with document authors and Process Sciences Lab to develop PV sampling plan and ensure accurate and complete entry into sample request system
• Provide PV schedule reports/updates to cross-functional teams
• Assist PV Lead with tracking PV Subteam action items
• Document and distribute meeting minutes

Supplementary Responsibilities:

• May act as Subject Matter Expert or liaison for the purposes of training PV authors and document reviewers
• Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing

Education

• Bachelor’s or Masters degree in Engineering or Life Sciences.
• 4-6 years experience in relevant field.
• 2-4 years with Masters degree

Knowledge, Skills, and Abilities

• Experience with Microsoft Office, SharePoint and Smartsheet
• Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies
• Proven management, communication, interpersonal, organizational and project management skills
• Demonstrated ability to work as part of a multi-disciplinary team
• Demonstrated technical proficiency
• Strong oral and written communication skills

Hourly Pay Rate Range (dependent on location, experience, expectation)

The pay range that Magnit reasonably expects to pay for this position is $22.94 - $30.59/hr on W2

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)