Senior Project Coordinator

Job Title:

Project Coordinator - Equipment Systems & Vendor Management

Job Description

The Project Coordinator - Equipment Systems & Vendor Management serves as the system owner and subject matter expert for maintenance, calibration, validation, and equipment documentation platforms, while acting as the primary interface for external service providers supporting GMP equipment. This role ensures that computerized maintenance and calibration systems and associated records accurately reflect the current state of equipment, events, and documentation, and that vendor services are effectively scheduled, tracked, and compliant with internal procedures and regulatory expectations.

The Project Coordinator partners closely with equipment owners, Quality, Supply Chain, Manufacturing, R&D, Procurement, Finance, and external vendors to maintain data integrity, drive on-time completion of planned activities, and resolve issues related to certificates, contracts, warranties, and equipment purchases. This position offers the opportunity to own end-to-end processes in a growing organization with strong backing and clear growth potential.

Responsibilities

+ Ensure maintenance, calibration, validation, and equipment tracking systems accurately reflect the current state of work, including equipment status, upcoming events, and completed activities.

+ Manage preventive maintenance, calibration, validation, and vendor service schedules, communicate plans and changes to equipment owners, and actively drive on-time completion of all scheduled work.

+ Monitor and follow up on open activities, vendor certificates, calibration reports, and documentation gaps to ensure timely closure in accordance with internal procedures and regulatory requirements.

+ Accurately document executed work in designated systems, confirming tasks, parts, labor, and results are captured in alignment with established procedures, data integrity expectations, and GMP standards.

+ Administer user accounts and access rights for equipment and maintenance systems, performing periodic reviews and timely updates to maintain appropriate role-based access and system security.

+ Support system validation, upgrades, and configuration changes by participating in requirements definition, testing, documentation, and change control activities.

+ Organize and maintain executed equipment records, certificates, manuals, validation protocols, and related documentation to ensure information is current, easily retrievable, and inspection-ready.

+ Collaborate with Procurement and Finance to manage vendor commercial documentation, including quotes, purchase orders, contracts, service agreements, and certificates of insurance.

+ Schedule and coordinate external vendor activities, manage site logistics, and ensure vendors comply with site safety, security, ISO quality, and GMP expectations.

+ Track and manage warranty-related issues such as faulty equipment, returns, exchanges, and associated documentation, driving timely resolution and maintaining clear records.

+ Facilitate communication between vendors and site stakeholders, including Manufacturing, R&D, Quality, and Supply Chain, to resolve service documentation, calibration reports, and related issues.

+ Identify and implement improvements to system workflows, documentation practices, and vendor processes to enhance efficiency, data integrity, quality engineering outcomes, and compliance.

+ Coordinate and support equipment validation activities, including IQ, OQ, PQ, process validation, and equipment validation, ensuring protocols and reports meet regulatory and internal standards.

+ Apply strong project coordination skills to plan, track, and report on equipment lifecycle management activities across multiple functional areas and teams.

+ Drive schedules and activities cross-functionally to achieve on-time results and maintain inspection readiness for GMP-regulated equipment.

Essential Skills

+ 6+ years of experience in equipment lifecycle management, with demonstrated ownership of systems, vendor services, and inspection readiness activities in a GMP-regulated pharmaceutical, biotech, or medical device environment with a high school diploma or GED; or 5+ years of similar experience with an Associate's Degree; or 4+ years of similar experience with a Bachelor's Degree.

+ Proven experience working within GMP-regulated environments in pharmaceutical, biotech, or medical device industries.

+ Strong systems aptitude with the ability to quickly learn, navigate, and optimize equipment management, maintenance, and calibration platforms.

+ High attention to data accuracy and detail, with a strong commitment to data integrity and compliance.

+ Demonstrated ability to anticipate upcoming needs and events and proactively plan and prepare to ensure readiness and timely execution.

+ Ability to manage multiple tasks, projects, and deadlines to on-time completion across multiple functional areas and teams.

+ Proven ability to effectively prioritize competing…