Computer Systems Validation (CSV) Consultant

Do you want the opportunity to leverage your skills to make a direct impact on the world’s leading life sciences, consumer products, and retail companies? Join Clarkston Consulting as a Computer Systems Validation Consultant to help deliver creative business solutions to our market-leading clients as a part of our team of experienced professionals.

We are looking for 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. Together, we can help find the answers to our clients most challenging business problems.

What You’ll Do

Clarkston gives you the opportunity to deliver great solutions, become recognized as an industry expert, and help build a great practice.

As a Computer Systems Validation Consultant at Clarkston, you will:

• Apply your professional knowledge of 21CFR Pt. 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

At Clarkston, we feel that we provide the greatest value to our clients through a combination of our industry expertise, business process knowledge, and consulting excellence.

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

• Have the support and mentorship of your Clarkston colleagues and leaders
• Own your career – you'll be able to take charge of your career journey with diverse opportunities to lead and expand your skillset both at the client site and within the firm
• Have the opportunity to make a real and positive impact not only the clients you work with, but on the firm as well

Requirements

What We’re Looking For:

An ideal candidate as a Computer Systems Validation Consultant would have the following qualifications and experience:

• 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
• Flexibility and adaptability - our Senior Consultants work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked
• Minimum degree required: Bachelor's 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. While travel is a requirement of the role, due to COVID-19 restrictions, all non-essential travel has been limited and any on-site requests are subject to review. When not traveling, consultants work from their home office. Relocation is not required.

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
• Life and Disability Insurance
• Company Equity or Stock Options
• Training and Professional Development investments

Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities. We hope you’ll join us!

COVID-19 Vaccination Statement

While Clarkston Consulting has not mandated vaccination at this time, COVID-19 vaccinations are required in order to access Clarkston Consulting facilities and those