Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:
- Digital Validation / QMS Specialist
What you will do:
- Facilitate and lead structured working sessions with cross-functional stakeholders (Validation, QC, Manufacturing, MSAT, Engineering) to define ~350 entities across Phase 1 and Phase 2.
- Complete and route GVLMS worksheets within the Veeva Validation Management module, operating with Validation Lead role access within the Veeva Vault environment.
- Pre-populate entity definition templates with available source data prior to each working session to maximize efficiency and minimize stakeholder time.
- Ensure all GVLMS worksheets are completed, routed, and progressed through the approval workflow in compliance with 21 CFR Part 11 electronic record requirements.
- Execute the scanning and Veeva upload of approximately 150 executed IOQ binders (estimated 50-200 pages each).
- Follow the Document Control Room retrieval SOP for all binder access and chain-of-custody handling.
- Build and maintain the Master Validation Data Repository — a traceability index covering 2-5 validation documents per system across ~350 qualified systems — drawing from documents already available in Veeva and the RMC Doc Control Room.
- Verify upload accuracy against source binder index and escalate discrepancies within 1 business day.
Qualifications:
- 3-5+ years of validation experience in a regulated pharmaceutical, biotech, or CDMO environment.
- Direct hands-on experience authoring and revising GxP validation documents — VMPs, SOPs, Guidance Documents, and validation templates.
- Experience with Validation Lifecycle Management Systems (VLMS) — Veeva Validation Management, Kneat, ValGenesis, or equivalent platform.
- Familiarity with the Veeva Vault ecosystem, including document routing, approval workflows, and 21 CFR Part 11 electronic record management.
- Experience executing IOQ binder documentation, scanning, and electronic document management in a GMP environment.
- Demonstrated ability to facilitate cross-functional working sessions with quality, engineering, and manufacturing stakeholders.
Preferred Qualifications
- Experience in a cell therapy, gene therapy, or advanced biologics GMP manufacturing environment.
- Prior experience supporting a GVLMS implementation or digital validation platform rollout.
- Direct experience with Veeva Validation Management — entity definition, worksheet creation, routing, and approval workflows.
- Familiarity with SAP PM (Plant Maintenance) for calibration or requalification scheduling.
- Experience supporting multiple concurrent document types under a single change control record.
- Prior experience working on a Pinnaql or similar consulting/managed service engagement — you understand the accountability model.
- Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related field.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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