Validation Operations Coordinator

Tolmar•Windsor, CO

5d•Onsite

About The Position

The Validation Coordinator provides coordination, documentation, and operational support to the validation organization to ensure validation activities are planned, tracked and documented efficiently and consistently. This role partners closely with validation engineers and cross-functional teams by coordinating schedules, managing validation documentation, and maintaining organized, inspection-ready records. The coordinator supports validation execution but does not serve as the technical or regulatory decision maker.

Requirements

Understanding of the validation lifecycle and concepts (IQ/OQ/PQ).
Familiarity with GMP documentation practices and data integrity principles.
Experience with EDMS, QMS, and validation tracking tools.
Strong attention to detail and organizational skills.
Ability to manage multiple priorities and deadlines.
Clear written and verbal communication skills.
Comfortable coordinating with cross-functional teams.
Ability to identify issues, troubleshoot and escalate appropriately.
Exposure to GMP environment and validation or quality documentation practices required.

Nice To Haves

Bachelor’s degree in Science, Engineering, Computer Science or related field (or an equivalent combination of education and experience).
Some experience in a regulated pharmaceutical, biotech or medical device environment preferred.
Experience supporting technical, validation, or quality teams is preferred.

Responsibilities

Coordinate the validation documentation lifecycle, including validation plans, protocols, reports, deviations and change control records.
Format, route, and track validation documents through review and approval workflows in accordance with established SOPs and templates.
Maintain organized validation documentation files within electronic document management systems (EDMS).
Track document status, version control, and archival in alignment with document control processes.
Escalate content gaps, discrepancies, or compliance questions to Validation Engineers or QA as appropriate.
Coordinate execution schedules for validation activities, including IQ, OQ, PQ executions, revalidations and periodic reviews.
Maintain validation trackers, logs and dashboards used by the validation team.
Monitor deliverables and milestones; flag overdue actions, missing documentation or schedule conflicts for follow-up by accountable team members.
Support coordination of validation-related meetings, walkthroughs and execution support activities.
Serve as coordination point between Validation, Engineering, Automation/IT, QA and Manufacturing for documentation and scheduling needs.
Support commissioning-to-validation handoff activities from an administrative and tracking perspective.
Facilitate information flow and follow-ups to support timely completion of validation activities.
Maintain well-organized, inspection-ready validation documentation and tracking records.
Provide back-room inspection support, including document retrieval and status tracking during internal audits and regulatory inspections.
Support rapid response to document request in coordination with Validation Engineers and QA.
Support validation-related change controls, deviations, and CAPAs by tracking status, documentation requirements and due dates.
Assist validation engineers with coordination of required impact assessments and supporting documentation.
Ensure validation documentation is complete and routed per SOP; escalate concerns or gaps as needed.
Adhere to department timelines and quality expectations.
Maintain effective working relationships through clear, professional communication.
Perform other duties as assigned.