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Key Responsibilities and Required Skills for Validation Supervisor

💰 $110,000 - $155,000

Quality AssurancePharmaceuticalsBiotechnologyMedical DevicesLeadershipManufacturing

🎯 Role Definition

The Validation Supervisor is a cornerstone of the Quality and Engineering functions, providing essential leadership and technical expertise to ensure that all equipment, facilities, utilities, processes, and systems are proven to be fit for their intended use. This role is pivotal in upholding the site's compliance with global regulatory standards (such as cGMP, FDA, and EMA) and internal quality policies. The supervisor leads a dedicated team of validation professionals, driving the planning, execution, and documentation of all validation lifecycle activities, thereby safeguarding product quality and patient safety. This individual acts as the primary subject matter expert for validation, guiding cross-functional teams and championing a culture of robust, science-based qualification and verification.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Validation Engineer / Specialist
  • Lead Quality Assurance Specialist
  • Senior Process Engineer with a focus on validation

Advancement To:

  • Validation Manager
  • Quality Assurance Manager
    or Systems Manager
  • Director of Quality Operations

Lateral Moves:

  • Technical Project Manager
  • Senior Compliance or Quality Systems Specialist

Core Responsibilities

Primary Functions

  • Direct and supervise the daily activities of the Validation team, including engineers and specialists, providing mentorship, training, and performance management to foster a high-performing and engaged group.
  • Develop, review, and maintain the site's Validation Master Plan (VMP), ensuring it is aligned with current regulatory expectations, industry best practices, and corporate quality objectives.
  • Author, review, and approve complex validation lifecycle documents, including User Requirement Specifications (URS), Validation Plans, Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols, and final summary reports.
  • Provide direct oversight and guidance during the field execution of validation protocols, ensuring activities are performed correctly, documented accurately in real-time, and that any deviations are promptly identified and addressed.
  • Lead and manage investigations into validation-related deviations, discrepancies, and failures, utilizing robust root cause analysis tools to determine the source and implement effective Corrective and Preventive Actions (CAPA).
  • Function as the Validation Subject Matter Expert (SME) during internal audits and external regulatory inspections (e.g., from the FDA, EMA), confidently presenting validation strategies and defending documentation and results.
  • Manage the validation project portfolio, including resource allocation, budget tracking, and timeline management, to ensure all departmental and capital project goals are met efficiently.
  • Collaborate closely with cross-functional departments, including Manufacturing, Engineering, Quality Assurance, and R&D, to ensure seamless integration of validation requirements into new projects and process changes.
  • Develop and implement validation strategies for a wide range of activities, including new equipment and facility qualification, process validation, cleaning validation, shipping validation, and computer system validation (CSV).
  • Review and approve Change Control records, providing detailed impact assessments from a validation perspective to ensure the validated state of systems and processes is maintained.
  • Establish and monitor key performance indicators (KPIs) for the validation department to track efficiency, compliance, and right-first-time metrics, reporting progress to senior management.
  • Ensure the team's compliance with all safety regulations and procedures during the planning and execution of validation work, promoting a strong safety-first culture.
  • Drive continuous improvement initiatives within the validation program, identifying opportunities to enhance efficiency, reduce cycle times, and implement risk-based validation approaches (ASTM E2500).
  • Manage the periodic review and requalification program for all validated equipment, utilities, and systems to ensure they remain in a constant state of control throughout their lifecycle.
  • Oversee the validation aspects of technology transfers, ensuring that processes and systems transferred from R&D or other sites are robustly qualified and validated for commercial manufacturing.
  • Author and revise Standard Operating Procedures (SOPs) and work instructions related to validation methodologies, documentation, and execution.
  • Provide technical support and troubleshooting expertise for complex issues encountered with validated equipment and automated systems.
  • Coordinate and manage the activities of external validation contractors or consultants, ensuring they meet the site’s quality standards and project deliverables.
  • Maintain a deep, current understanding of evolving global cGMP regulations, guidelines (e.g., GAMP 5, ICH), and industry trends, and translate these into practical site policies and procedures.
  • Champion and implement data integrity principles across all validation activities, ensuring all electronic and paper-based data is attributable, legible, contemporaneous, original, and accurate (ALCOA+).

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis to support investigations or process improvement.
  • Contribute to the organization's broader quality and data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Regulatory Expertise: Deep and applied knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211, 820, and Part 11), EU EudraLex Volume 4, and ICH guidelines.
  • Validation Lifecycle Mastery: Expertise in the theory and practice of IQ/OQ/PQ for a variety of systems, including manufacturing equipment, facilities, utilities (WFI, clean steam, HVAC), and analytical instruments.
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  • Process & Cleaning Validation: Proven experience in designing and executing robust process performance qualification (PPQ) and cleaning validation/verification studies.
  • Computer System Validation (CSV): Proficiency in validating automated systems according to GAMP 5 principles, including experience with SCADA, PLC, MES, and LIMS.
  • Risk Management Methodologies: Skill in applying risk-based approaches (e.g., FMEA, HACCP) to determine the scope and extent of validation and qualification activities.
  • Technical Documentation: Exceptional ability to author, review, and approve high-quality, scientifically sound technical documents, protocols, and reports.
  • Root Cause Analysis & CAPA: Formal training and experience in structured problem-solving methodologies to investigate deviations and implement effective corrective actions.
  • Statistical Analysis: Competency in using statistical tools (e.g., Minitab, JMP) for data analysis, process capability assessment, and setting acceptance criteria.
  • Project Management: Demonstrated ability to manage multiple projects, create schedules, track progress, and utilize project management software (e.g., MS Project, Smartsheet).

Soft Skills

  • Leadership & Mentoring: A natural ability to lead, inspire, and develop a team of technical professionals, fostering a collaborative and accountable environment.
  • Communication & Influence: Excellent verbal and written communication skills, with the ability to articulate complex technical concepts clearly to both technical and non-technical audiences and influence decision-making.
  • Critical Thinking: Strong analytical and problem-solving skills, capable of making sound, risk-based decisions under pressure.
  • Meticulous Attention to Detail: An unwavering commitment to accuracy and thoroughness in all aspects of documentation and execution.
  • Cross-Functional Collaboration: A proven team player with a track record of building strong working relationships with peers in Engineering, Manufacturing, and Quality.
  • Adaptability & Resilience: Ability to thrive in a fast-paced, dynamic environment, managing competing priorities and adapting to changing regulatory and business needs.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree

Preferred Education:

Master's Degree

Relevant Fields of Study:

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

Experience Requirements

Typical Experience Range:

A minimum of 7-10 years of hands-on experience in validation within a cGMP-regulated environment (pharmaceutical, biotech, or medical device), including at least 2-3 years of proven experience in a leadership, supervisory, or senior-level role with direct reports or significant project lead responsibilities.

Preferred:

Experience in a sterile/aseptic manufacturing environment or with biologics/large molecule products is highly desirable. Direct experience successfully leading validation efforts during FDA or other health authority inspections is a significant plus.

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