Compliance Solution Consultant

Compliance Consultant, Validation

Own the validation lifecycle and help bring cures to life.

At VaLogic Bio, we support those in the quest for the cure. Our clients in biotech, pharma and life science research count on us to make sure their equipment, systems and processes are qualified, compliant and ready for whatever comes next.

We are looking for an experienced Compliance Consultant who knows validation from start to finish. You will be the trusted expert on site, guiding clients through full lifecycle validation and delivering work that stands up to any audit. If you enjoy solving real problems, working face to face with clients, and seeing the impact of your work, we want to talk to you.

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 our 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

Why VaLogic Bio

• Work that matters, supporting the science behind new therapies and cures
• Variety: new clients, new sites and new challenges, not the same project year after year
• A small, collaborative team where your expertise is valued and your voice counts
• Benefits that include health, dental and vision insurance, short and long term disability, and unlimited paid time off
• A culture built on our I CARE values: Integrity, Customer Centered, Accountability, Respect and Excellence, all driven by Passion

VaLogic Bio is ISO 9001, ISO/IEC 17025 and ISO/IEC 27001 certified, and quality is at the heart of everything we do.

If you are ready to bring your validation expertise to a team that will value it, apply today.

No recruiters or agencies, please. We are not accepting unsolicited resumes from third parties for this position.

VaLogic Bio is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Qualifications

Qualifications

• Bachelor's degree in a science, engineering or technical field, or equivalent combination of education and experience
• 1 to 3 years of experience in a GMP, GLP or other regulated environment, or in the assigned service line
• Working knowledge of good documentation practices and regulated industry expectations
• Strong attention to detail and organization
• Clear written and verbal communication skills
• Ability to work independently at client sites and as part of a team
• Proficiency with Microsoft Office and the ability to learn company systems
• Valid driver's license, reliable transportation, and ability to travel to client sites

Preferred

• Experience in more than one VaLogic Bio service line
• Industry certifications relevant to the service line (for example NEBB, CETA or NSF for certification work)
• Familiarity with standards relevant to the assigned work, such as 21 CFR Parts 11, 210 and 211, ISO 14644, ISO/IEC 17025, USP chapters or GAMP 5

Physical demands and work environment

• Work is performed at client sites, in labs, cleanrooms and manufacturing areas, and in the office
• Must be able to follow gowning requirements and work in controlled environments
• May require standing, walking, bending, reaching and lifting up to [50] pounds
• Occasional early, late or weekend work may be needed to meet client schedules

Success in this role looks like

• Deliverables are accurate, complete and on time
• Clients find the Consultant reliable, professional and easy to work with
• The Consultant is building skills and cross training toward Senior Compliance Solution Consultant