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Key Responsibilities and Required Skills for Validation Coordinator

💰 $ - $

Quality AssuranceRegulatory AffairsPharmaceuticalBiotechnologyMedical Device

🎯 Role Definition

The Validation Coordinator is a pivotal role within our quality and manufacturing framework, acting as the central hub for all validation activities. This position is responsible for orchestrating the entire lifecycle of equipment, system, and process validation to ensure strict adherence to GxP, FDA, and international regulatory standards. Success in this position hinges on meticulous planning, flawless execution of validation schedules, and seamless communication between Quality, Engineering, Manufacturing, and R&D departments. You are the guardian of compliance, ensuring that every validated component is audit-ready and functions exactly as intended to guarantee product safety and efficacy.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Control Analyst
  • Manufacturing Associate / Technician (in a regulated environment)
  • Document Control Specialist

Advancement To:

  • Senior Validation Specialist / Engineer
  • Quality Assurance Manager
  • Validation Manager

Lateral Moves:

  • Quality Assurance Specialist
  • Project Coordinator / Manager
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Coordinate, schedule, and track all validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, facilities, utilities, and processes.
  • Develop, manage, and maintain the site Validation Master Plan (VMP), ensuring it remains current and aligned with corporate policies and regulatory expectations.
  • Act as the primary point of contact and liaison between cross-functional teams (e.g., Engineering, Manufacturing, Quality Control, and IT) to ensure timely completion of validation projects.
  • Review and facilitate the approval of validation protocols, test scripts, and final reports to ensure they meet cGMP standards and internal quality requirements.
  • Author, review, and revise Standard Operating Procedures (SOPs) related to validation activities and processes.
  • Manage the validation documentation lifecycle, ensuring all records are accurately completed, properly stored, and readily accessible for audits in our electronic document management system (EDMS).
  • Lead and participate in risk assessments (e.g., FMEA) to identify potential failure modes and define appropriate validation testing strategies.
  • Investigate and document deviations, non-conformances, and out-of-specification results encountered during validation execution.
  • Initiate and manage Change Control records related to new or modified equipment, systems, and processes, assessing the impact on the validated state.
  • Coordinate the execution of Corrective and Preventive Actions (CAPAs) stemming from validation discrepancies, deviations, or audit findings.
  • Maintain a comprehensive schedule and calendar of all validation, re-validation, and periodic review activities to ensure ongoing compliance.
  • Prepare and present validation project status updates, timelines, and key metrics to department management and key stakeholders.
  • Support the qualification of new laboratory instruments and automated systems, ensuring they are fit for their intended use.
  • Manage external vendors and contractors performing validation services, ensuring their work meets our quality standards and project timelines.
  • Ensure that all personnel involved in executing validation protocols are adequately trained and qualified.
  • Generate and maintain an accurate inventory and status log of all validated equipment and systems on site.
  • Coordinate process validation (PV) campaigns for new products or major process changes, from protocol development to final report approval.
  • Support computer system validation (CSV) projects, ensuring compliance with 21 CFR Part 11 and data integrity principles.
  • Compile comprehensive validation packages for new and existing systems, ensuring they are complete and audit-ready.
  • Participate in the planning and coordination of facility shutdowns and startups, focusing on the re-qualification of critical systems and utilities.

Secondary Functions

  • Assist in hosting and supporting internal, client, and regulatory agency audits by providing documentation and explaining validation strategies.
  • Contribute to continuous improvement initiatives aimed at enhancing the efficiency and effectiveness of the validation program.
  • Provide training and guidance to junior staff and colleagues from other departments on validation principles and procedures.
  • Maintain and archive all validation-related documentation in accordance with record retention policies.

Required Skills & Competencies

Hard Skills (Technical)

  • In-depth knowledge of GxP regulations (cGMP, GDP, GCP) and guidelines from regulatory bodies like the FDA, EMA, and ICH.
  • Strong understanding of the validation lifecycle (IQ, OQ, PQ) for equipment, utilities, processes, and cleaning methods.
  • Proficiency in authoring, reviewing, and executing technical documentation, including VMPs, protocols, and reports.
  • Experience with Quality Management Systems (QMS) and electronic document management systems (EDMS) like Veeva Vault, MasterControl, or TrackWise.
  • Familiarity with risk management principles and tools (e.g., FMEA, HACCP).
  • Working knowledge of Computer System Validation (CSV) principles and 21 CFR Part 11 requirements for electronic records and signatures.
  • Competency with project management tools such as MS Project, Smartsheet, or JIRA to track timelines and resources.

Soft Skills

  • Exceptional organizational and planning skills with the ability to manage multiple complex projects simultaneously.
  • Meticulous attention to detail and a commitment to accuracy in all documentation and processes.
  • Strong interpersonal and communication skills, with a proven ability to collaborate effectively with cross-functional teams and stakeholders at all levels.
  • Proactive problem-solving and critical-thinking abilities to navigate challenges and resolve deviations.
  • Excellent time management and prioritization skills to meet tight deadlines in a fast-paced environment.
  • A resilient and adaptable mindset, capable of managing changing priorities and unforeseen obstacles.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in a scientific or engineering discipline.

Preferred Education:

  • Bachelor's or Master's degree in a relevant field.

Relevant Fields of Study:

  • Life Sciences (Biology, Chemistry, Biochemistry)
  • Engineering (Chemical, Biomedical, Mechanical)
  • Pharmaceutical Sciences

Experience Requirements

Typical Experience Range:

  • 3-5 years of direct experience within a regulated GxP environment (pharmaceutical, biotech, or medical device).

Preferred:

  • Direct hands-on experience in a validation, quality assurance, or manufacturing engineering role is highly sought after. Experience facing regulatory audits (e.g., FDA, EMA) is a significant plus.
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