What are the responsibilities and job description for the Dat Integrity CSV/CQV Lab Equipment Contractor | New York, New York | Onsite position at Stellent IT LLC?
Job Details
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, LabChips, 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.
Qualifications:
- 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
Best regards,
Lavesh Kumar
| Sr. Technical Recruiter
STELLENT IT A Nationally Recognized Minority
Certified Enterprise
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