Validation Manager

• Coordinate validation activities within the facility design, construction, and qualification project, utilizing hands-on involvement and coordinating with specialist contractors as necessary.
• Maintain close communication with building contractors, engineers, and equipment vendors to ensure accurate information exchange and adherence to vendor qualification protocols.
• Facilitate Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification/Operational Qualification (IQ/OQ) processes, offering guidance on documentation and best practices.
• Oversee ongoing validation activities (DQ, IQ, OQ, PQ) post-production launch.
• Evaluate vendor protocols, develop or approve in-house protocols, and compile comprehensive qualification documentation.
• Explore outsourcing options for validation and present alternative solutions when applicable.
• Establish and monitor Key Performance Indicators (KPIs) to ensure performance and budgetary goals are met, reporting KPIs periodically to the Quality Management Review committee.
• Manage team members' performance, development, training, and compliance, in addition to contributing to the overall validation strategy for the site.
• Act as a technical liaison for both internal and external stakeholders and play a pivotal role in validating the facility and manufacturing unit within the project team.
• Collaborate effectively with other project team members to achieve timely completion of the GMP manufacturing facility according to the established program.
• Develop and review GMP documentation, including validation documentation, Standard Operating Procedures (SOPs), and training materials.
• Provide training on validation procedures as needed and coordinate with Manufacturing and Engineering to create a qualification schedule that minimizes disruptions to production.
• Ensure adherence to health, radiation safety, and environmental policies while working safely within ISO Class 7 and 8 environments, following SOPs and wearing appropriate Personal Protective Equipment (PPE).
• Be prepared for weekend and after-hours work as required.
• Stay current with industry developments, standards (e.g., ISPE, ISO), and pharmaceutical trends.

Qualifications:

Essential:

• Bachelor's degree or equivalent in STEM or related field.
• Minimum 5 years of experience leading and conducting validation activities in GMP facilities, including aseptic and/or sterile manufacturing.
• Demonstrated ability to manage compliance with GMP regulations and guidance, with deep knowledge of validation in cleanroom manufacturing environments and associated equipment.
• Proficiency in generating high-quality GMP documentation, including policies, SOPs, protocols, and reports.
• Strong communication skills and ability to collaborate across functions.
• Familiarity with Quality Management Systems and adept at identifying and reporting deviations and completing Corrective and Preventive Actions (CAPAs).

Desirable:

• Experience in introducing new processes and equipment into GMP manufacturing facilities.
• Experience with validating new GMP manufacturing facilities.