Job Description
Title: Validation Project Manager
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Industry: Pharmaceutical & Life Sciences
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Experience: 5+ Years
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Job Type: Contract
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Job Summary:
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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.
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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.
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Key Roles & Responsibilities:
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- 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.
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Preferred Qualifications:
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- 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.
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