Salary: $47.83 - 66.49 per hour
Reference: 1096936
job summary:
A Validation Specialist is needed for a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, in the Portsmouth, NH area. The CSV, Analytical, and Enterprise Validation Specialist leads and supports system validation, administration, and compliance activities across multiple departments to ensure equipment and applications meet regulatory and operational standards.
location: Portsmouth, New Hampshire
job type: Contract
salary: $47.83 - 66.49 per hour
work hours: 8am to 5pm
education: Bachelors

responsibilities:

• Lead validation activities for software updates, new system introductions, administration, and decommissioning of systems/applications.
• Collaborate with cross-functional teams such as Manufacturing, OT, CSV, Engineering, and QA.
• Act as Subject Matter Expert (SME) for Quality Control, Manufacturing, and others on CSV, analytical, and enterprise systems.
• Review and approve Installation/Operational Qualifications; draft Performance Qualifications.
• Assist in generating URS documents, ER/ES compliance materials, and data integrity/audit trail risk assessments.
• Prepare system administration and configuration documents using vendor manuals.
• Manage procurement of analytical equipment, ensuring compliance with specs, budgets, and installation.
• Administer user and software functions on enterprise systems; troubleshoot complex system issues.

Education and Experience:

• Bachelor of Science - Science related discipline or relevant experience in the field.
• 5-10 Years or experience.

LI-SS6

qualifications:

• Experience level: Experienced
• Education: Bachelors

skills:

• ValidationPurchasing / Procurement

• 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.

• Lead validation activities for software updates, new system introductions, administration, and decommissioning of systems/applications.
• Collaborate with cross-functional teams such as Manufacturing, OT, CSV, Engineering, and QA.
• Act as Subject Matter Expert (SME) for Quality Control, Manufacturing, and others on CSV, analytical, and enterprise systems.
• Review and approve Installation/Operational Qualifications; draft Performance Qualifications.
• Assist in generating URS documents, ER/ES compliance materials, and data integrity/audit trail risk assessments.
• Prepare system administration and configuration documents using vendor manuals.
• Manage procurement of analytical equipment, ensuring compliance with specs, budgets, and installation.
• Administer user and software functions on enterprise systems; troubleshoot complex system issues