Job Description

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)

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