Validation Project Manager

Industry: Pharmaceutical & Life Sciences

Experience: 5+ Years

Job Type: Contract

Job Summary: We are looking for an experienced Project Manager with a strong background in the pharmaceutical industry to lead and coordinate projects involving Commissioning & Qualification (C&Q) documentation, GMP compliance, and digital transformation of validation processes using the KNEAT validation platform. The ideal candidate will bring a combination of project management expertise and hands-on technical knowledge of C&Q activities, pharmaceutical equipment qualification, and GMP-regulated environments. This individual will be responsible for managing project timelines, coordinating cross-functional teams, overseeing documentation migration, and ensuring successful project delivery in compliance with regulatory requirements.

Key Roles & Responsibilities: Lead and manage end-to-end pharmaceutical C&Q projects, ensuring delivery within defined timelines, scope, and quality standards. Oversee the migration of paper-based Commissioning & Qualification (C&Q) documentation into the KNEAT digital validation platform. Manage KNEAT implementation, configuration, document workflows, and digitization activities in coordination with technical and validation teams. Ensure all project activities comply with GMP requirements, FDA regulations, GAMP 5 guidelines, and applicable industry standards. Coordinate the preparation, review, execution, and approval of qualification documents, including IQ, OQ, PQ protocols and reports. Manage project schedules, milestones, deliverables, resource allocation, and project risks. Work closely with CQV Engineers, Validation Specialists, Quality Assurance, Engineering, and other stakeholders to ensure smooth project execution. Monitor C&Q documentation progress, identify project bottlenecks, and drive timely resolution of issues. Ensure data integrity, document traceability, and proper documentation practices throughout the project lifecycle. Lead project meetings, track action items, communicate progress, and provide regular status updates to stakeholders. Manage deviations, change controls, CAPAs, and project-related quality issues in collaboration with QA teams. Support continuous improvement initiatives to streamline qualification processes and improve documentation efficiency.

Preferred Qualifications: Minimum 5+ years of experience in the pharmaceutical, biotechnology, or life sciences industry. Proven experience in project management within GMP-regulated manufacturing or engineering environments. Strong hands-on experience with the KNEAT validation platform. Solid understanding of Commissioning & Qualification (C&Q) and CQV processes. Experience with digitization or migration of paper-based validation and qualification documentation into electronic platforms. Good understanding of GMP, FDA regulations, GAMP 5, and 21 CFR Part 11.Strong project planning, stakeholder management, communication, and coordination skills. Ability to manage multiple deliverables, project priorities, and cross-functional teams effectively.