Compliance Solution Consultant
VALOGIC BIO LLC
Summary
Own the validation lifecycle and help bring cures to life. VaLogic Bio supports biotech, pharma and life science research clients by ensuring their equipment, systems and processes are qualified, compliant and inspection-ready.
Job description
What you will do
- Lead and execute full lifecycle validation projects, from planning through final summary report
- Write, review and execute validation deliverables, including validation plans, URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices and summary reports
- Qualify laboratory equipment, manufacturing equipment, utilities, facilities and computerized systems
- Support commissioning, FAT/SAT and the handoff into qualification
- Investigate and document deviations, discrepancies and change controls during execution
- Apply current regulations and industry guidance so every deliverable is inspection ready
- Serve as a technical resource for clients and teammates, and help mentor less experienced staff
- Travel to and from client sites as projects require
- Spot opportunities to improve templates, methods and client experience
- Perform all other duties as assigned
What you bring
- At least 5 years of hands-on experience in full lifecycle validation in a GMP regulated environment (pharma, biotech, medical device or a related industry)
- Strong working knowledge of 21 CFR Parts 11, 210 and 211, EU GMP Annex 11 and Annex 15, and GAMP 5
- Proven experience writing and executing IQ/OQ/PQ protocols and summary reports
- Excellent technical writing, attention to detail and good documentation practices
- The confidence to work directly with clients, manage priorities and keep projects on schedule
- A bachelor's degree in engineering, life sciences or a related field, or equivalent experience
- A valid driver's license, reliable transportation, and the ability to travel to client locations
Nice to have
- Computer system validation (CSV) or CSA experience
- Cleaning, process or cleanroom validation experience
- Experience with electronic validation or quality systems
Requirements
- At least 5 years of hands-on experience in full lifecycle validation in a GMP regulated environment
- Strong working knowledge of 21 CFR Parts 11, 210 and 211, EU GMP Annex 11 and Annex 15, and GAMP 5
- Proven experience writing and executing IQ/OQ/PQ protocols and summary reports
- Excellent technical writing, attention to detail and good documentation practices
- Confidence to work directly with clients, manage priorities and keep projects on schedule
- Bachelor's degree in engineering, life sciences or a related field, or equivalent experience
- Valid driver's license, reliable transportation, and ability to travel to client locations
- Computer system validation (CSV) or CSA experience (preferred)
- Cleaning, process or cleanroom validation experience (preferred)
- Experience with electronic validation or quality systems (preferred)
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Short Term Disability
- Long Term Disability
- Unlimited PTO
Company overview
VaLogic Bio LLC is a specialized GMP/GxP compliance and technology solutions provider serving the life sciences industry since 2001. Headquartered in Frederick, Maryland with additional offices in Texas and Massachusetts, the company offers comprehensive advisory, consulting, and compliance services designed to simplify regulatory complexities and promote innovation for biotechnology, pharmaceutical, and life science organizations. Their expertise spans consulting, software-as-a-service (SaaS) solutions, laboratory services, and certification programs, with their flagship LogiPoint® facility monitoring system providing real-time environmental monitoring for critical facilities. The company's service portfolio includes cleanroom certifications, biological safety cabinet testing, HEPA filter integrity testing, temperature mapping, calibration services, and validation programs. As a veteran-owned business with over 150 years of collective expertise among department directors, VaLogic Bio has worked with more than 400 biotech companies of all sizes, helping them navigate FDA regulations and achieve operational excellence while maintaining compliance with GMP standards.