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Project Manager
4 weeks ago
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:
- Project Manager - Commissioning, Qualification, and Validation
We are seeking an experienced Project Manager to lead projects from construction and installation through commissioning, qualification (C&Q), and final validation of production, packaging, and utility/facility systems in a regulated manufacturing environment. This role will serve as the single point of accountability for project execution, ensuring all deliverables meet client expectations, timelines, and regulatory requirements while maintaining strict compliance with cGMP and FDA regulations.
Responsibilities
- Oversee the entire project lifecycle, including construction, installation, commissioning, qualification, and validation (CQV) of manufacturing, packaging, and utility/facility systems.
- Develop and implement project master plans, including detailed schedules, resource planning, risk mitigation strategies, and budget oversight.
- Coordinate with contractors, vendors, and cross-functional teams during construction and installation to ensure alignment with CQV requirements.
- Ensure commissioning and qualification activities comply with industry standards, regulatory requirements, and client expectations.
- Lead the execution of risk assessments, design reviews, test matrices, FATs, SATs, commissioning, installation, operational, and performance qualification for all applicable systems.
- Work closely with engineering, automation, IT, quality, and operations teams to ensure facility and equipment readiness.
- Manage project cost, schedule, and scope, ensuring timely and cost-effective delivery.
- Oversee the preparation and quality of CQV documentation, including protocols, reports, and turnover packages.
- Conduct regular meetings and provide progress updates, reports, and metrics to stakeholders.
- Ensure compliance with GMP, EHS, and client standards throughout all project phases.
- Manage project staffing, including hiring, mentoring, and professional development of team members.
- Bachelor's degree in engineering, life sciences, or a related field.
- Minimum of 10 years of project management experience in pharmaceutical, biotech, or regulated manufacturing environments.
- Strong experience managing projects from construction and installation through commissioning and qualification.
- In-depth knowledge of cGMP, FDA regulations, and industry best practices.
- Proficiency with project management tools and software (e.g., MS Project, Excel).
- PMP certification preferred but not required.
- Excellent leadership, communication, and organizational skills.
This role requires a hands-on, proactive leader capable of overseeing all project phases, ensuring smooth transitions from construction and installation to commissioning, qualification, and final validation.
