Purpose and Scope

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.

Essential Duties & Responsibilities

Validation Documentation & Records Management

• 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.

Validation Scheduling & Tracking

• 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.

Cross-Functional Coordination

• 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.

Inspection & Audit Readiness

• 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.

Change Management & Quality System Support

• 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.

Other Responsibilities

• Adhere to department timelines and quality expectations.
• Maintain effective working relationships through clear, professional communication.
• Perform other duties as assigned.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

Technical & Administrative

• 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.

Organizational & Communication

• 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.

Education & Experience

• 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.
• Exposure to GMP environment and validation or quality documentation practices required.
• Experience supporting technical, validation, or quality teams is preferred.

Working Conditions

• Working conditions include general office environment.
• Business demands may require the need to work extended hours.

Compensation and Benefits

• Pay: $29.00 - $33.00 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.