Digital Validation / QMS Specialist

About the Role

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Responsibilities

• 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.

Requirements

• 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.

About Us

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.