Our client is seeking a highly motivated Validation Engineer with validation experience to join their team. The Validation Engineer is a key individual contributor role within our client's Validation Department. The Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has practical experience in qualification and validation.
The Validation Engineer will partner with internal customers to meet the needs of client projects, facility upgrades, capital expansion projects, and laboratory systems. They will possess a demonstrated ability to influence positive outcome without direct reporting authority. Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.
Essential Job Functions:
• Perform Qualification activities on utilities, equipment and laboratory systems. This includes, but is not limited to, clean utilities, autoclave, washer, filler, laboratory instruments, etc.
• Interact with clients to provide validation support including but not limited to, customer product launches, new equipment qualifications.
• Support and provide validation oversight for capital expansion projects/build outs
• Assist in authoring validation lifecycle documentation and as well as document template, validation strategies and policies
• Review facility changes and provide input on re-validation and re-qualification of equipment
• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables
• Engage in a cross functional team and work closely with other supporting groups including Engineering and Operations to support and monitor validation and process improvement efforts
• Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.
Special Job Requirements:
• Bachelor’s degree or higher in STEM discipline
• 2-4 years of experience in Validation or related discipline
• 2+ year GMP experience required or other regulated industry
• Physically capable of working onsite
• Cleaning Validation experience preferred