Job Details

002V5953 Senior CQV Engineer/Senior Validation Engineer
Please contact Amanda Mazza, ...@tworivercp.com
**FTE or Contractor**

JOB RESPONSIBILITIES

• Draft protocol templates, media fill summaries, and standardized reports
• Populate bracketing documentation tables and support protocol generation
• Maintain central trackers for protocol reviews, approvals, and interventions
• Coordinate feedback cycles across site/global stakeholders and update documents accordingly
• Provide day-to-day execution support to ensure delivery remains on schedule
• Support documentation drafting and onsite coordination cross-functionally with Validation and QA leads

• Bachelor's Degree in an industry-related field
• Minimum 5+ years industry experience, including direct experience with Media Fill Validation
• Demonstrated experience in Commissioning & Validation activities
• Demonstrated experience authoring and executing protocols, drafting media fill summaries and standardized reports
• Experience in a pharmaceutical / FDA-regulated manufacturing environment
• Working knowledge of cGMP and facility/equipment validation requirements
• Ability to write clearly, concisely, and persuasively in a professional environment
• Demonstrated ability to interact effectively with all levels of the organization
• Ability to work as part of a cross-functional team
• Strong problem-solving, critical thinking skills, and attention to detail