Job description

Work type:3 days on site, 2 days remote(Hybrid)

Job Function:

• Support key validation projects to ensure timely completion and serve as a computer system validation lead on project teams.
• Ensure that computerized systems are maintained in a manner compliant with corporate and regulatory requirements.
• Draft and review computer system validation lifecycle documentation (Plans, Requirements, Protocols, Summaries, etc.)

Primary Responsibilities:

• Managing/assessing validation efforts and drafting/reviewing/approving/executing validation lifecycle documents related to computerized laboratory systems supporting in-process/release testing and enterprise standards.
• Assist with leveraging/authoring OQ and PQ protocols across sites; execution and writing of tests scripts.
• Execute based system for audits.
• 20% Periodic Reviews and 80% Validation.
• Serving as a member of the Validation oversight department responsible for Enterprise harmonization of LAB sites in support of QC LIMS systems, including re-defining/authoring and assessing all relevant SOP and Policy implementations; ensuring that all validation requirements conform to data integrity standards and compliance in current state and prior to scheduled system releases.

Qualifications

• 8-10 Years of experience.
• Excellent Computer System Validation Skills
• Should have prior experience as CSV lead.
• Excellent Instrumentation Skills
• Validation experience in a Lab Systems environment.
• A true Lead, able to work independently with little or no guidance.
• Experience with queries and change control systems
• Excellent written and oral communication skills.
• Excellent customer facing skills.
• Must maintain a working knowledge of cGMP and GxP regulations related to laboratory and database applications.
• Able to think analytically and learn quickly.
• Must have previous experience and knowledge of regulatory requirements related to computer system validation (including 21 CFR Part 11) and 820
• Ability to take initiative, to be assertive, and to build quality working relationships.

Job Types: Full-time, Contract

Pay: $56.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Branchburg, NJ 08853: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• CSV lead: 7 years (Required)
• Validation: 7 years (Required)
• Lab Systems: 6 years (Required)
• 21 CFR Part 11: 6 years (Required)
• cGMP: 6 years (Required)
• GxP: 6 years (Required)
• QC LIMS systems: 6 years (Required)

Work Location: In person

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