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Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Job Title: Senior Computer Systems Validation SpecialistLocation: Portsmouth, NH 03801Duration: 10 MonthsJob Type: Temporary AssignmentWork Type: Onsite

Summary:

We are seeking a Senior Computer Systems Validation Specialist / CSV Specialist Level IV to provide technical leadership, mentoring, and training in assessing new and modified computer systems to ensure compliance with company policies, procedures, and industry regulations. This role is responsible for leading Computer Systems Validation (CSV) activities, performing risk assessments, reviewing change requests and test scripts, drafting validation protocols, managing GMP documentation updates, and serving as the QA CSV representative on complex projects within a cGMP-regulated environment. The position also supports QMS processes, inspection readiness, audit support, and continuous improvement of CSV procedures and practices.

Responsibilities

• Lead and execute Computer Systems Validation (CSV) activities for new and modified computer systems.
• Perform risk assessments to evaluate system compliance and validation requirements.
• Review change requests, test scripts, validation deliverables, and supporting documentation.
• Draft, review, and approve validation protocols and related CSV documentation.
• Initiate, review, and support revisions to GMP documentation and CSV-related procedures.
• Serve as the CSV project lead for complex and large-scale validation projects.
• Oversee all phases of the CSV lifecycle, including planning, execution, reporting, and closure.
• Schedule qualification activities and coordinate personnel to meet business, manufacturing, engineering, and quality objectives.
• Support and participate in Change Control, Deviations, and CAPA activities within the Quality Management System (QMS).
• Mentor and provide guidance to junior CSV specialists and team members.
• Revise, maintain, and improve CSV Standard Operating Procedures (SOPs).
• Assess departmental compliance and readiness from both business and regulatory perspectives.
• Act as the CSV Subject Matter Expert (SME) during regulatory inspections, customer audits, and internal audits.
• Collaborate with Quality, Manufacturing, Engineering, IT, and Validation teams to ensure compliant system implementation.
• Maintain compliance with company safety policies, cGMP requirements, and industry regulations.
• Perform additional duties as assigned.

TekWissen Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.