GMP Equipment Systems & Vendor Programs Lead

Talentify; Eden Prairie (MN); Presencial; USD 65.000 - 95.000; Tempo integral

Resumo da vaga

Talentify seeks a Project Coordinator for Equipment Systems & Vendor Management to own maintenance, calibration, validation, and documentation platforms. You will partner with Quality, Supply Chain, Manufacturing, R&D, Procurement, and external vendors to ensure data integrity and on-time delivery of activities in a GMP-focused environment.

You will manage system access, support validation and changes, and organize comprehensive equipment records and certificates to ensure inspection readiness

Qualificações

• Experience with maintenance, calibration, validation systems and equipment documentation.
• Knowledge of GMP standards and regulatory expectations.
• Strong documentation and data integrity focus.

Responsabilidades

• Ensure maintenance, calibration, validation, and equipment tracking reflect current state of work.
• Manage preventive maintenance, calibration, validation, and vendor service schedules; communicate plans to owners and drive on-time completion.
• Monitor open activities, vendor certificates, calibration reports, and gaps; ensure timely closure per procedures and regulations.
• Document executed work in systems; confirm tasks, parts, labor, and results align with procedures and GMP standards.
• Administer user accounts and access rights for equipment systems; conduct periodic reviews for security and role-based access.
• Support system validation, upgrades, and configuration changes through requirements, testing, documentation, and change control.
• Organize and maintain equipment records, certificates, manuals, and validation protocols for easy retrieval and inspection readiness.
• Coordinate with Procurement and Finance to manage vendor documentation (quotes, purchase orders, contracts, service agreements, insurance certificates).
• Schedule external vendor activities and site logistics; ensure compliance with safety, ISO quality, and GMP expectations.
• Track warranty-related issues and returns.

Conhecimentos

Vendor management

GMP compliance

Equipment maintenance

Data integrity

Documentation control

Descrição da vaga

Talentify seeks a Project Coordinator for Equipment Systems & Vendor Management to own maintenance, calibration, validation, and documentation platforms. You will partner with Quality, Supply Chain, Manufacturing, R&D, Procurement, and external vendors to ensure data integrity and on-time delivery of activities in a GMP-focused environment.

You will manage system access, support validation and changes, and organize comprehensive equipment records and certificates to ensure inspection readiness