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 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 to learn more about our diversity initiatives.