Senior CSV Engineer (Labs)

We're currently partnered with a top 10 U.S. Biopharma organization that's currently hiring for a Senior CSV Engineer position who have experience and knowledge with benchtop analytical instruments and lab equipment. If you're looking to grow within a renowned organization and hone in on your CSV skills, then this opportunity is for you.

Key Responsibilities:

• Develop, review, and execute laboratory CSV documentation: Ensure comprehensive creation, meticulous review, and precise execution of Computer System Validation (CSV) documents for laboratory systems.
• Hands-on experience with lab techniques and general lab analytical operations: Apply practical expertise in various laboratory techniques and analytical operations, ensuring accurate and reliable results.
• Complete protocol and qualification activities: Conduct thorough protocol development and qualification activities, ensuring all laboratory processes meet required standards.
• Understanding of baseline lab standards and system suitability verification: Maintain a deep understanding of established laboratory standards and perform system suitability checks to ensure compliance and optimal performance.
• Basic experience with IT system formats, configurations, and workflows: Utilize foundational knowledge of IT system formats, configurations, and workflows to support laboratory operations and data management.
• Document any findings of non-compliance: Accurately record any instances of non-compliance, ensuring transparency and accountability in laboratory practices.
• Assist with strategy regarding remediation activities: Contribute to the development of effective strategies for remediation activities, addressing any identified issues or non-compliance.
• Assist with review of remediation activities: Support the review and evaluation of remediation efforts, ensuring corrective actions are properly implemented and effective.

Key Qualifications:

• Bachelor's degree in Engineering or a related field.
• Extensive experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers, and automated titrators.
• Knowledge of CSA/CSV principles and their application in a lab validation setting.
• Experience in pharmaceutical cGxP environments.
• Proven track record in generating and completing laboratory CSV deliverables.
• Preferred experience with TrackWise, Veeva, DeltaV, and/or Empower.
• Experience in GMP regulated environments.
• Exceptional attention to detail and organizational skills in project work.
• Ability to work independently on assigned tasks without mentorship.
• Strong capability to work both independently and as part of a team.
• Strong problem-solving and critical thinking abilities.
• Excellent organizational and time management skills.
• Meticulous attention to detail.
• Knowledge of GMP and GDP.
• Experience with and adaptability to high levels of challenge and change.