Join Our Client as a Validation Specialist in Portsmouth, NH an industry leader driving biotech innovation! Seeking a CSV Specialist Level 3 in Vacaville with expertise in Computer System Validation, 21 CFR Part 11, and GAMP guidelines. Lead projects and elevate your career with a premier, forward-thinking team.
location: Portsmouth, New Hampshire
job type: Contract
salary: $59.52 - 82.73 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Serve as the QA CSV project lead, conducting risk assessments, protocol drafting, and validation activities for DeltaV and Syncade systems.
- Execute core QMS processes including Change Controls, Deviations, and CAPAs to maintain computerized systems in full adherence to cGMP standards.
- Draft, review, and revise CSV SOPs, protocols, and technical engineering documents (P&IDs, specifications, submittals) in accordance with 21 CFR Part 11 and ISPE GAMP guidelines.
- Assist with site audits and inspections for Our Client while providing guidance and leadership to junior team members.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
