What are the responsibilities and job description for the Design Verification consultant position at S4 Analytics LLC?
About the Company
S4 Analytics is a growing consulting and workforce solutions firm headquartered in Texas and New Jersey, specializing in connecting highly skilled professionals with leading organizations across the Life Sciences, Semiconductor, Automotive, Defense, Data Center, and IT industries. We are committed to building long-term partnerships by delivering top talent and customized staffing solutions that support our clients’ evolving business and project needs.
Position Overvie
wWe are seeking an experienced Design Verification Consultant to support the design, verification, and qualification of a new drug substance manufacturing facility build-out. The ideal candidate will have expertise in pharmaceutical CAPEX projects, design verification, GMP compliance, P&ID reviews, URS development, and risk-based qualification activities. This hands-on role will work cross-functionally with Engineering, Manufacturing, Quality, Validation, and vendors to ensure facilities, equipment, utilities, automation systems, and processes meet design requirements, regulatory expectations, and operational readiness goals from early design through commissioning and startup
Skills & Qualification
- Design Verification (DV) for facilities, equipment, automation, and process change
- CAPEX pharmaceutical experience - facility design buildout (Pharmaceutical and Site Expansion experience preferred
- GMP compliance; working knowledge of ICH Q8–Q11, FDA, EMA, and ISPE guidanc
- Heavy P&ID experience, work on P&ID design reviews, review P&ID’s line by line. Ability to describe design verification from start to finis
- Experience with early design process, detail design experience and specific examples around detail design previous work. Ability to work pre-conceptual design experience is a mus
- Must have change control examples and strategies for execution phases of a new site build out from a design perspectiv
- Previous experience with material flow, personnel flow and warehouse material flo
- Must have vendor experience, managing scope and quality expectations and technical alignment. Align schedules with FAT and SAT testing to ensure specs are in line with site tea
- Working examples of early design and detailed design experienc
- Experience authoring and approving DV plans, protocols, reports, traceability matrices, and risk assessment
- Technical lead and design verification authority for assigned project scope
- User Requirements Specification (URS) development in cross‑functional environment
- Requirement traceability, testability, and technical feasibility assessmen
- Review of vendor Functional Design Specifications (FDS), Detailed Design Specifications (DDS), and engineering documentatio
- Risk‑based design qualification, verification, and commissioning suppor