Validation Specialist

SGS Consulting; Portsmouth (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

SGS Consulting is seeking a CSV Analytical and Enterprise Validation Specialist to lead validation activities, ensuring compliance within pharmaceutical manufacturing. The role involves collaboration with multiple departments and necessitates a Bachelor's in a science discipline, along with several years of experience. Successful candidates will provide expertise in CSV and Quality Assurance.

Qualifications

• 5-10 years of relevant experience required.
• Experience in pharmaceutical manufacturing and validation.
• Ability to work closely with quality assurance and manufacturing teams.

Responsibilities

• Lead validation activities for software updates and new system introductions.
• Review and approve Installation and Operational Qualifications.
• Generate User Requirements Specifications and Risk Assessments.

Skills

Analytical skills

Troubleshooting

Quality Assurance

Education

Bachelor of Science - Science related discipline

Job description

1 day ago Be among the first 25 applicants

This range is provided by SGS Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $66.00/hr

Direct message the job poster from SGS Consulting

CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to 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

• Perform other duties as assigned.

Education: Bachelor of Science - Science related discipline or relevant experience in the field

Experience 5-10 Years

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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