Technical Project Manager

Job not on LinkedIn

🔥 3 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🤓 Technical Project Manager

👻 Ghost score 12%

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Logo of GMP Pros, Inc.®

GMP Pros, Inc.®

11 - 50 employees

Founded 2013

💼 Consulting

🍽️ Food & Beverage

🏭 Manufacturing

Consulting • Food & Beverage • Manufacturing

GMP Pros, Inc. ® is a professional consulting engineering firm specializing in regulated manufacturing sectors like pharmaceuticals, food, and biologics. The company focuses on optimizing capacity, efficiency, and quality for its clients by providing expert engineering project teams that excel in electronic batch records implementation, production engineering, and data science analytics. With a commitment to regulatory compliance and industry standards, GMP Pros helps manufacturers achieve significant improvements in operational performance and product yield.

📋 Description

• Own delivery and full accountability for GMP Pros' performance under the Oxford subcontract • Develop and actively manage the detailed MS Project schedule, including critical path and baseline management • Identify and escalate risks proactively • Manage cross-workstream dependencies • Own the validation documentation layer across both workstreams • Plan validation protocols • Coordinate Kneat incidents • Oversee Veeva VQD documentation • Operate within a three-party governance structure involving GMP Pros, Oxford, and GSK • Manage competing priorities and significant schedule pressure

🎯 Requirements

• 5+ years of project management experience in FDA-regulated pharmaceutical or biopharmaceutical manufacturing environments • Direct experience managing MES or eBR implementation projects from design through PPQ, including Siemens OpCenter, Rockwell PharmaSuite, Emerson DeltaV Batch, or equivalent • Proficiency with MS Project for schedule development, critical path definition, and baseline management • Working knowledge of 21 CFR Part 11, EU Annex 11, and the CSV/CQV lifecycle • Experience with IQ/OQ/PQ structure, validation protocol authorship, and documentation requirements in regulated systems • Experience with Kneat or an equivalent electronic validation management system for protocol authorship and incident management • Experience with Veeva Vault QualityDocs (VQD) or equivalent QMS/DMS for validation lifecycle documentation • Ability to manage risk registries, escalate proactively, and protect schedules • PMP certification or equivalent project management credential preferred • Direct experience with Siemens OpCenter Execution Pharma preferred • Experience supporting PPQ execution and post-go-live hypercare preferred • Familiarity with GSK, Pfizer, Merck, Lilly, or other large pharma MES environments preferred • Familiarity with SAP-MES and OSI-PI integrations in a pharma manufacturing context preferred • Familiarity with Microsoft Teams and SharePoint • Prior experience in a prime/subcontract delivery model or multi-vendor program environment preferred

🏖️ Benefits

• 1099/W2 engagement options • Remote work

Apply Now

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