Computer Systems Validation (CSV) Consultant

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths.

Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You'll Do

As a Computer Systems Validation (CSV) Consultant at Clarkston you will :

• Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device, and other GxP and GAMP regulated environments
• Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications
• Engage your clients and teammates in value-add relationships to deliver outstanding project outcomes and identifying new opportunities to serve your clients
• Share best practices, industry knowledge, and personal expertise to educate both clients and fellow consultants, in formal and ad hoc settings
• Continually update your own knowledge base and that of your teammates by participating in educational and networking opportunities

How You'll Grow

Beyond your day-to-day responsibilities, throughout your career at Clarkston you will :

• Receive the support and mentorship of your Clarkston colleagues and leaders
• Expand your existing skillset with internal and external professional development opportunities

Requirements

What We're Looking For :

• Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements / Design / Functional Specifications, IQ / OQ / PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
• Experience with systems including (but not limited to) on-premise and cloud solutions such as SAP, Veeva, LIMS, Documentum, Trackwise, Empower, MES, Serialization solutions;

as well as networks / infrastructure and hardware qualification

• Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles
• Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical, biotech, medical device and other GxP and GAMP regulated environments
• Experience with Data Integrity impacts on Validations including Audit Trail Risk Assessment
• Flexibility and adaptability - our Consultants work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked
• Bachelor's or 4-year degree from an accredited college or university

Travel Requirement

Travel is an integral part of this role and is estimated to average 30-50%. This may vary based upon client and project needs.

When not traveling, consultants work from their home office. Relocation is not required.

More About Clarkston

Founded in 1991, Clarkston Consulting delivers technology and management solutions to market leaders in the life sciences, consumer products, and retail industries.

At Clarkston, we cultivate success - for our clients, for our people, and for our firm. We utilize a team approach leveraging our collective expertise and industry knowledge to solve our clients' business challenges.

Benefits

Our benefits include :

• Comprehensive Health and Wellness Benefits (Medical, Dental, Vision, and more)
• 401k with company contributions
• Paid vacation, personal days, holidays, and sick leave
• Paid Parental Leave and Family Building Benefits (Adoption, Surrogacy, and Infertility Support)
• Life and Disability Insurance
• Training and Professional Development investments, Tuition Assistance, and more

Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities.

Clarkston Consulting is an equal opportunity employer. We are committed to ensuring our firm is rich in diverse skills, competencies, strengths, personalities, and culture.

We foster an inclusive environment that embraces the unique contributions of our people to further our purpose. Please visit Diversity @ Clarkston to learn more about our diversity initiatives.