SRG, the leader in the Life Sciences human capital industry, is looking for a CSV Analytical and Enterprise Validation Specialist to join our client's manufacturing team in Portsmouth, NH. This role will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate.

*W2 contract only; we CANNOT accept visa status candidates at this time.

MUST HAVES:

• Bachelor of Science
• Experience 5-10 Years
• Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.

JOB RESPONSIBILITIES:

• Support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.
• Review and Approval of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Prepare Administration and Configuration specification document with support from vendor user manual.
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
• Create and or Revise SOPs for CSV, Analytical and enterprise systems and applications.
• Participate on Risk Assessments
• Review/Approve Commissioning Qualification Validation Documents

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.