What are the responsibilities and job description for the Project Manager position at LLoyd Staffing?
Pharmaceutical Project Manager ( NC)
Rocky Mount, NC
Up to $62.00 an hour
Long Term Contract
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.
Stakeholder Management
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.
Technical Oversight
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.
Qualifications
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.
Key Competencies
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
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