What are the responsibilities and job description for the Project Manager position at PQE Group?
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45 nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.
Due to a constant growth, we are looking for a an experienced Pharmaceutical Project Manager to lead the installation and qualification of a new vial filling line in our client's Small Volume Parenteral (SVP) Terminally Sterilized (TS) Filling Facility in Rocky Mount, NC.
Responsibilities include, but are not limited, to the following:
• Develop and manage the project plan for the installation and qualification of the Filling Line and all related equipment (e.g., vial unscrambler, washer, depyrogenation tunnel, filler, capper), including timelines, budgets, and resources.
• Coordinate with engineering, QA, manufacturing, and facilities for smooth execution.
• Ensure classified rooms meet ISO and EU grade requirements.
• Manage utility upgrades in the SVP Facility TS Area (WFI, compressed air, nitrogen).
• Ensure all installation and qualification activities comply with cGMP guidelines, FDA regulations, and company SOPs by developing and reviewing IQ, OQ, and PQ protocols, and coordinating with quality assurance to meet regulatory documentation standards.
• Conduct risk assessments and implement mitigation strategies for equipment installation, room classification, and utility modifications.
• Serve as the main contact for stakeholders, providing updates and managing vendor relationships to ensure timely delivery and installation.
• Collaborate with engineering and facilities teams to integrate control systems, implement door controls and HVAC modifications, and ensure proper historian integration for classified rooms.
Our ideal candidate should have the following features:
• Bachelor's degree in Engineering, Pharmacy, or related field; Master's degree preferred.
• Minimum 10 years of experience in pharmaceutical project management, with a focus on manufacturing equipment installation and qualification.
• Strong knowledge of cGMP, FDA regulations, and other relevant industry standards.
• Experience with IQ/OQ/PQ protocols and validation processes in FDA-regulated environments.
• PMP certification or equivalent preferred.
• Proficiency in project management software and tools.
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.
Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
