Director- Validation Services

VALOGIC BIO LLC•Frederick, MD

13d•$175,000 - $195,000•Onsite

About The Position

Director of Validation Services VaLogic Bio | Maryland | In-Office | Full-Time Leadership Role Player-Coach Life Sciences Travel Required ABOUT VALOGIC BIO VaLogic Bio provides compliance-driven services and digital solutions for life sciences organizations including pharmaceutical manufacturers, biotech companies, CDMOs, and regulated laboratories. The company supports regulated environments through laboratory services, CQV validation services, calibration and certification programs, and digital platforms that support monitoring, asset management, and data integrity. THE OPPORTUNITY This is a rare chance to step into a pivotal leadership role at a company that is growing and hungry. As Director of Validation Services, you will be the senior technical and people leader for our validation practice. You will roll up your sleeves and do the work alongside your team, while also setting the vision, building the team culture, and owning the client relationships that fuel our growth. If you are the kind of person who gets energized by solving complex validation challenges, mentoring junior engineers, and hearing a client say "that was exactly what we needed" then this role was built for you.

Requirements

10+ years of hands-on validation and commissioning experience in the life sciences industry.
Deep expertise across IQ/OQ/PQ equipment qualification, process validation, cleaning validation, and CSV.
4-5+ years managing and developing teams with varying levels of experience.
Strong working knowledge of FDA regulations and GMP guidelines applicable to validation.
Outstanding client-facing communication skills, both written and verbal.
Willingness to travel out of state as projects require.
Bachelor's degree in Engineering, Life Sciences, or a related field.

Nice To Haves

Prior experience in a consulting or contract services environment.
Professional certifications such as CQE, CQA, or equivalent.
Experience in biopharmaceutical manufacturing, fill-finish, or laboratory environments.

Responsibilities

Lead and execute validation projects
Plan, author, execute, and approve validation and commissioning deliverables including IQ/OQ/PQ, process validation, cleaning validation, and CSV/computer system validation.
Serve as the senior technical lead on client engagements from kickoff to final report.
Ensure all work meets applicable regulatory standards including 21 CFR Parts 11, 211, and 820, GAMP 5, and EU GMP Annex 11.
Build and lead a great team
Hire, onboard, and develop validation professionals across experience levels, from associates to senior consultants.
Coach and mentor team members with a genuine investment in their growth.
Build a team culture where quality, accountability, and client obsession are non-negotiable.
Own client relationships
Serve as the primary senior contact for key clients, building long-term partnerships grounded in trust and results.
Proactively communicate project status, risks, and solutions.
Never let a client be surprised.
Participate in business development by identifying expansion opportunities within existing accounts and supporting proposals for new work.
Drive operational excellence
Establish and maintain standard templates, procedures, and quality standards for the validation practice.
Manage project timelines, resources, and budgets in close collaboration with operations leadership.