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Validation & Quality Compliance
Every piece of equipment, utility system, and software application in an FDA-regulated facility must be validated before it touches a product. Every quality system must be documented, auditable, and maintained. This work is not optional. It is mandated by regulation, and the talent required to execute it is specialized, scarce, and in constant demand.
APC provides the validation engineers, CSV specialists, quality consultants, and program managers who keep pharmaceutical, biotech, and medical device facilities in compliance. Whether you need a single protocol writer for six months or a team of fifteen for a multi-year facility build-out, we deliver professionals who have done this work before, in environments like yours.
What We Cover
- Equipment Qualification (IQ/OQ/PQ): Installation, operational, and performance qualification for manufacturing equipment, utilities, and production systems.
- Computer System Validation (CSV): Validation of LIMS, MES, ERP modules, and any GxP software system under 21 CFR Part 11.
- Process & Cleaning Validation: Documented proof that manufacturing processes and cleaning procedures consistently produce acceptable results.
- Utilities Validation: HVAC, purified water systems, clean steam, compressed gases, and other critical utility systems.
- Quality Systems & Compliance: Quality assurance, quality control, CAPA management, deviation investigation, and audit preparation.
- Medical Device Validation: Design validation, IQ/OQ/PQ under 21 CFR Part 820, and ISO 13485 quality systems.
Why Companies Choose APC for Validation
- We Understand the Work: Our recruiters assess validation professionals on technical depth, protocol writing ability, and regulatory awareness. We don’t send resumes. We send professionals who can execute on day one.
- Campaign-Scale Staffing: Major facility build-outs require teams of multiple validation professionals working in parallel. We have the recruiting infrastructure to staff multiple roles.
- CDMO-Ready: Contract manufacturers face unique validation challenges because every new client product triggers new qualification cycles. We maintain a pipeline of professionals ready to deploy to meet your needs.
- Local to the RTP Validation Market: The Research Triangle is one of the top three pharmaceutical validation markets in the country. We recruit from this talent pool every day.
Our validation and quality professionals include validation engineers at all levels, senior validation consultants, validation program managers, CSV specialists, quality assurance engineers, quality control analysts, CAPA specialists, regulatory compliance analysts, GMP documentation specialists, cleaning validation specialists, and audit readiness consultants.
award winning service
For more than three decades, we’ve helped outstanding talent find their place in exceptional organizations. Our continued recognition as a top staffing firm reflects how we adapt and deliver for both clients and candidates, year after year.
How it works
Flexible Contract Options
Three ways to build your team, each tailored to how you work best.
It's not just about checking boxes on a resume. We're focused on finding talent that truly fits in skills, culture, and impact.
3 to 6 monthsLong-term hires succeed when they align with your team's values and bring the skills and drive to make a lasting impact.
6 to 18+ monthsOur direct hire services are all about finding the perfect match. The right candidate for the right role, built to last.
Permanent placementFrequently Asked Questions
Installation Qualification (IQ) verifies that equipment is installed correctly per manufacturer specifications. Operational Qualification (OQ) proves it operates within specified parameters under normal and worst-case conditions. Performance Qualification (PQ) demonstrates it consistently produces acceptable output under real production conditions. We place professionals experienced in all three phases.
Yes. We regularly staff teams of multiple professionals for major validation campaigns, including execution engineers, senior protocol writers, CSV specialists, and program managers. We can scale up for facility build-outs and scale down as projects move into steady-state.
Yes. We provide flexible staffing solutions tailored to your needs, whether you’re looking for short-term project support, the option to “try before you hire,” or long-term full-time employees.
CSV is one of the most requested specializations. We place professionals experienced in validating LIMS, MES, ERP, and other GxP systems under 21 CFR Part 11, including both on-premise and cloud-based platforms.
Absolutely. With professionals in 44+ states and a national recruiting network, we support clients across the U.S. in virtually any market.
Yes. We place quality and validation professionals who work under 21 CFR Part 820 and ISO 13485, including design validation, equipment qualification, and quality systems management for medical device manufacturers.
Yes. Our job doesn’t end when a candidate starts. We stay engaged to ensure a smooth transition, provide support throughout the contract, and help drive long-term success for both our clients and professionals.
Validation projects typically run 12–36 months. We offer contract, contract-to-hire, and direct placement to match your project timeline and organizational needs.
Need Validation or Quality Professionals? Let’s Talk.
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