Dat Integrity CSV​/CQV Lab Equipment Contractor Onsite

Title:

CSV/CQV Lab Equipment Contractor

Location:

New York, New York | Onsite Duration: 12 months with 2 potential extensions ( 3 year long estimated project) Interview Process:
One-step interview via Teams with hiring managers Responsibilities:

• Perform system administrative tasks, including commissioning and basic troubleshooting of equipment.
• This role will work with a variety of lab equipment, including SoloVPEs, Nova Flex2s, Kingfisher Apex, Lab Chips, Wave Rockers, and Sartochecks.
• Onboard new equipment to ensure compliance with standards and protocols.
• Move between various buildings throughout the day to support equipment and systems.
• Gown into controlled areas as required, adhering to GMP (Good Manufacturing Practice) standards.
• Collaborate with process sciences transitioning into the GMP space to ensure equipment is properly controlled and documented.
• Manage and execute a lighter version of commissioning for equipment categorized as support impact.
• Work on 320 ECNs (Engineering Change Notices) and 70 systems, including multiple units of the same configuration, organized in a phased approach over the next 18 months.
• Engage in hands‑on work with equipment, including writing SOPs (Standard Operating Procedures), configuration specifications, and templating information.
• Handle systems up to 8 years old that may lack documentation, ensuring data is securely sent to designated locations.
• Utilize strong interpersonal skills to negotiate and collaborate with process sciences teams.
• Ensure thorough verification processes are followed, especially during periods of change.

• Experience with Biovia U Lab is a plus.
• Background in data integrity and the pharmaceutical industry.
• Hands‑on experience with commissioning equipment, including direct interaction with equipment to understand its functionality.
• Strong documentation skills without relying solely on SMEs (Subject Matter Experts) for information.
• Willingness to gown into controlled areas as needed.
• Excellent interpersonal and negotiation skills.