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Project Manager
Job Description
We are seeking an experienced Pharmaceutical Project Manager with a minimum of 10 years of experience 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. The ideal candidate will have a strong background in pharmaceutical manufacturing, GMP regulations, and project management.
Responsibilities
Project Planning and Execution
- Develop and maintain a comprehensive project plan for the installation and qualification of Filling Line, including timelines, budgets, and resource allocation.
- Coordinate with cross-functional teams including engineering, quality assurance, manufacturing, and facilities to ensure seamless project execution.
- Manage the installation and qualification of all equipment in scope, including vial unscrambler, washer, dehydrogenation tunnel, conveyors, LAF systems, filler, capper, and associated components.
- Oversee the creation and modification of classified rooms for Filling Line, ensuring compliance with ISO and EU grade requirements.
- Manage utility modifications in the SVP Facility TS Area, including WFI, compressed air, nitrogen, and non-qualified utility changes.
Quality Assurance and Compliance
- Ensure all installation and qualification activities adhere to cGMP guidelines, FDA regulations, and company SOPs.
- Develop and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Coordinate with the quality assurance team to ensure all documentation meets regulatory requirements.
Risk Management
- Conduct risk assessments for all aspects of the project, including equipment installation, room classification changes, and utility modifications.
- Develop and implement risk mitigation strategies to address potential issues throughout the project lifecycle.
- Serve as the primary point of contact for all project stakeholders, including senior management, vendors, and regulatory bodies.
- Provide regular project status updates and reports to key stakeholders.
- Manage relationships with equipment vendors and contractors to ensure timely delivery and installation of all components.
- Collaborate with engineering teams to oversee the integration of control systems, including SCADA, FactoryTalk Asset Centre, and environmental monitoring systems.
- Ensure proper implementation of door controls, interlocks, and historian integration for the new classified rooms.
- Coordinate with facilities and engineering teams on HVAC modifications and commissioning.
- 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.
- Proven track record of successfully managing complex pharmaceutical manufacturing projects.
- Experience with IQ/OQ/PQ protocols and validation processes in FDA-regulated environments.
- Excellent leadership, communication, and problem-solving skills.
- PMP certification or equivalent preferred.
- Proficiency in project management software and tools.
- Ability to manage multiple complex tasks simultaneously and prioritize effectively.
- Strong analytical and decision-making skills.
- Excellent interpersonal skills with the ability to work effectively in a cross-functional team environment.
- Demonstrated ability to lead and motivate project teams.
- Thorough understanding of pharmaceutical manufacturing processes and equipment
Meet Your Recruiter

Erin Hoke
My career began in the hospitality industry, but I sought a change for better work-life balance and family considerations. I moved into the world of recruiting in 1999, I started in light industrial roles and gradually specialized in contract and permanent placements across a wide range of technical industries.
In 2006, I co-founded Recruiting Resources with my father, focusing on professional services and human resources staffing for both small and national companies. In 2011, I became an independent recruiter, partnering with a small Firm in the Maryland area where I concentrated on sourcing talent primarily for the Life Sciences industry but also expanded into non-technical areas.
Throughout my career, I have valued personal connections and helping individuals find positions that align with their expertise and lifestyle. My journey reflects adaptability, entrepreneurship, and a passion for facilitating meaningful career opportunities for others. I joined Lloyd Staffing in Aug 2024 to specialize again in Life Sciences.
In my free time, I spend most of my time with my son. We have become quite the fishermen over the past 5 years.
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