Senior Project Coordinator

Project Coordinator Equipment Systems & Vendor Management

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 priorities and drive on-time completion of work in a fast-paced environment.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional stakeholders and external vendors.
• Strong organizational and time management skills, with a structured approach to documentation and record keeping.
• Experience with calibration, validation, validation protocols, IQ, OQ, PQ, process validation, and equipment validation in a regulated setting.
• Demonstrated capability in project coordination related to equipment systems, vendor activities, and quality engineering initiatives.
• Working knowledge of ISO quality standards and their application to equipment and vendor management.

Additional Skills & Qualifications

• Experience using BMRAM (Blue Mountain RAM) equipment management software.
• Experience driving schedules and activities cross-functionally to achieve on-time results and maintain inspection readiness.
• Experience managing vendor commercial documentation, including contracts, purchase orders, quotes, service agreements, and certificates of insurance.
• Experience in pharmaceutical, biotech, or medical device environments, particularly in GMP and ISO quality contexts.
• Exposure to quality engineering practices related to equipment lifecycle, calibration, and validation.
• Ability to identify and implement continuous improvement initiatives in system workflows, documentation practices, and vendor processes.
• Comfort working closely with Manufacturing, R&D, Quality, Supply Chain, Procurement, and Finance teams.
• Interest in taking ownership of end-to-end processes and growing into expanded responsibilities as the organization continues to scale.

Work Environment

This role is primarily based in an office setting with a dedicated cubicle or desk, working extensively with computerized maintenance, calibration, and equipment management systems. The position also requires regular access to a clean room environment where biological materials, including pig organs, are present, and adherence to all site safety, security, GMP, and ISO quality procedures is essential. Team members follow established clean room protocols and appropriate attire requirements specific to controlled environments. The organization is in a growth phase, backed by a well-funded parent company, offering a culture that values ownership of processes, cross-functional collaboration, and professional development opportunities.

Job Type & Location

This is a Permanent position based out of Eden Prairie, MN.

Pay and Benefits

The pay range for this position is $65000.00 - $85000.00/yr. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

Workplace Type

This is a fully onsite position in Eden Prairie, MN.

Application Deadline

This position is anticipated to close on Aug 21, 2026.