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Skills
- Agricultureunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Change Requests/Ordersunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Scienceunmatched
- Computer Skillsunmatched
- Computer Systemsunmatched
- Continuous Improvementunmatched
- Corporate Policiesunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Customer Support/Serviceunmatched
- Detail Orientedunmatched
- Diseaseunmatched
- Document Managementunmatched
- Documentationunmatched
- GMP (Good Manufacturing Practices)unmatched
- Gene Therapyunmatched
- Information Technology & Information Systemsunmatched
- Internal Auditunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Requirementsunmatched
- Material Scienceunmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Mentoringunmatched
- Multitaskingunmatched
- Nutritionunmatched
- Organizational Skillsunmatched
- People Managementunmatched
- Personal Careunmatched
- Presentation/Verbal Skillsunmatched
- Procedure Developmentunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Riskunmatched
- Risk Analysisunmatched
- Safety Complianceunmatched
- Safety/Work Safetyunmatched
- Software Engineeringunmatched
- Standard Operating Procedures (SOP)unmatched
- System Validationunmatched
- Systems Analysisunmatched
- Technical Leadershipunmatched
- Test Plan/Scheduleunmatched
- Test Scriptsunmatched
- Time Managementunmatched
- Training/Teachingunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
Description
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 Specialist
Location: Portsmouth, NH 03801
Duration: 10 Months
Job Type: Temporary Assignment
Work 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.
Required Skills
- Bachelor's Degree in Computer Science, Software Engineering, or a related technical discipline.
- Experience in Computer Systems Validation (CSV) within pharmaceutical, biotechnology, medical device, or other regulated industries.
- Strong knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures.
- Strong understanding of ISPE GAMP guidelines and risk-based CSV methodologies.
- Experience performing system risk assessments and validation impact assessments.
- Ability to review and approve change requests, test scripts, validation protocols, and GMP documentation.
- Experience with Quality Management System (QMS) processes, including Change Control, Deviations, and CAPAs.
- Knowledge of cGMP regulations and regulated manufacturing environments.
- Experience overseeing full CSV lifecycle activities, including qualification planning and execution.
- Experience supporting qualification scheduling and coordinating validation resources.
- Ability to function as a CSV SME during inspections and audits.
- Strong written and verbal communication skills.
- Excellent organizational, planning, and time management skills.
- Strong attention to detail and documentation accuracy.
- Ability to manage multiple priorities and work effectively in cross-functional teams.
- Leadership and mentoring skills with the ability to train and support junior team members.
- Commitment to compliance, quality, safety, and continuous improvement practices.
TekWissen Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.
Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Computer/IT Services |
| Salary | $45–$55 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.