Validation Team Lead

100% Onsite at PA

**No C2C**

We are seeking an experienced Validation Team Lead to join our Client tem. The ideal candidate will have a minimum of 8 years of experience in validation within the pharmaceutical industry and will be responsible for developing and implementing comprehensive validation strategies.

Key Responsibilities:

• Develop and maintain Validation Master Plans (VMPs) and individual validation plans in alignment with company procedures and industry standards
• Collaborate with commissioning and validation teams to ensure cohesive validation strategies
• Oversee the creation of validation plans for automation, single-use systems, process equipment, utilities, facilities, and cleaning validation
• Develop and implement PQ-PPQ (Performance Qualification-Process Performance Qualification) strategies
• Identify and implement efficiency strategies, including family/system approaches and leveraging opportunities
• Coordinate with equipment manufacturers and consultants to optimize FAT/SAT (Factory Acceptance Test/Site Acceptance Test) processes
• Create implementation schedules for validation tasks, including dependencies and critical paths
• Develop out-of-place validation approaches, including "sandbox" methodologies where applicable
• Prepare comprehensive Implementation Summary Reports detailing validation strategies and rationales
• Optimize the use of validation management software (e.g., KNEAT) to streamline validation processes

Requirements:

• Minimum 8 years of experience in pharmaceutical validation, with at least 3 years in a leadership role
• Bachelor's degree in Engineering, Pharmacy, or a related scientific field; advanced degree preferred
• In-depth knowledge of cGMP regulations and FDA/EMA guidelines related to pharmaceutical manufacturing
• Strong understanding of validation principles for equipment, processes, cleaning, and computer systems
• Experience with risk-based validation approaches and leveraging strategies
• Experience with Cytiva Systems (TFF. Mixers etc.). Automated Biotinylation System and Single Use Systems (Bags, Filter Assemblies, Transfer Sets, Cassettes etc.)
• Proficiency in validation management software (e.g., KNEAT) and project management tools
• Excellent analytical and problem-solving skills
• Strong leadership and team management abilities
• Outstanding written and verbal communication skills

Desired Qualities:

• Experience with single-use systems and modern Biotechnology manufacturing technologies
• Familiarity with automation systems in pharmaceutical manufacturing
• Knowledge of lean manufacturing principles and continuous improvement methodologies
• Ability to work effectively in a fast-paced, dynamic environment
• Strong attention to detail and commitment to data integrity
• Proven track record of successful project delivery in validation

The successful candidate will play a crucial role in ensuring the quality and compliance of our manufacturing processes through effective validation strategies. If you are a results-driven validation professional with a passion for excellence in pharmaceutical manufacturing, we encourage you to apply.