Validation Engineering Supervisor

Overview

Join to apply for the Validation Engineering Supervisor role at MTVS - Meimad TV Studios. The Validation Supervisor will be responsible for developing validation strategies to ensure systems, processes and products meet specified requirements and regulatory standards. The role will supervise validation initiatives and ensure compliance to quality standards and regulations (EMA and FDA). The Validation Supervisor will develop and improve the overall validation program to ensure a lifecycle approach is incorporated and will support Therapeutics validation activities in the commercial manufacturing facility.

• Developing and Implementing Validation Strategies:
  Create and maintain validation programs ensuring a lifecycle approach and that they meet regulatory requirements and project goals.
• Manage Master Validation Plan, through the review and implementation of all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
• Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
• Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases to meet FDA and EMA regulatory requirements.
• Responsible for managing Qualification/Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables.
• Provide status and progress reports for validation/qualification activities or projects for Management Review Meetings.
• Develop a computerized systems validation approach that meets FDA and EMA guidelines.
• Validation Documentation Management:
  Support the drafting of URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system.
• Develop/draft various validation templates incorporating the lifecycle strategy.
• Provide guidance on development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ) as well as CSV documentation to ensure data integrity requirements are met.
• May review and analyze analytical and physical data generated from executed validation/qualification activities.
• Review/draft validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
• Prepare documentation and provide support for regulatory/compliance inspections.
• Support internal and external audits, regulatory inspections, and remediation efforts related to equipment and software validation and compliance.
• Review and approve periodic reviews of system(s) validation. Ensure appropriate plans are determined for gaps identified during periodic reviews.
• Mentor and Train Team Members on Validation Processes and Requirements:
  Managing validation activities and ensuring efficient execution of validation tasks; support training activities related to qualification and validation activities through assignments in ACE and on the job training (OJT).
• Risk Management:
  
  Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (e.g., Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis) and ensure risk management is incorporated into the validation program.
• Responsible for keeping the qualification/validation of the facility, equipment and processes current; review proposed changes for impact to system qualification and validation; identify and complete requalification activities to support change completion.
• Collaboration:
  
  Work closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables; meet project objectives and timelines including scheduling, qualification testing, and deviation resolution.
• Continuous Improvement:
  Identify opportunities for improvement in validation processes and procedures and implement corrective actions.

• BS in scientific discipline or equivalent work experience
• 3-5 years of validation experience in pharmaceutical or medical device environments
• Experience in cGMP environments
• Strong understanding of validation principles, methodologies, and regulatory requirements
• Experience implementing validation programs to meet lifecycle approach in pharmaceutical environment
• Ability to write procedures and protocols and review documentation
• Ability to supervise and motivate teams, manage projects, and communicate effectively
• Ability to analyze data, identify risks, and develop effective solutions
• Ability to…