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Lead Validation Engineer
2 months ago
Job Title: Lead Validation Engineer Location: Massachusetts, (Onsite) Contract Duration: 12 Months Initially Company Overview: Our Client, a leading pharmaceutical company, is seeking a highly experienced Lead Validation Engineer to manage and address a backlog of equipment validations related to their packaging equipment, including fill-finish processes, printers, and scanners. Following this, the engineer will take a pivotal role in a site expansion project, focusing on the validation of 20 new or relocated pieces of equipment. Position Overview: The Lead Validation Engineer will play a critical role in overseeing and executing validation activities for both existing and new equipment at our Clients Massachusetts facility. The role involves leading a team of senior engineers, managing the validation strategy, and ensuring compliance with GMP standards for a combination product that involves filling a hydrogen peroxide solution into vials. This position requires a deep understanding of aseptic/sterile fill/finish environments and proven leadership in validation processes. Key Responsibilities: Technical Leadership: Provide strategic direction and leadership for all validation activities related to equipment, utilities, manufacturing, and packaging, ensuring alignment with GMP standards. User Requirement Specifications (URS): Collaborate with cross-functional teams (manufacturing, facilities, quality, regulatory) to develop comprehensive URS documents. IQ/OQ/PQ Oversight: Lead the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) processes for new equipment and utility systems. Hands-on execution may be required, but the primary responsibility will be overseeing senior engineers. Risk-Based Validation: Implement a risk-based validation approach to streamline testing and documentation, optimizing resources and timelines. Master Validation Plan: Develop and manage the Master Validation Plan, coordinating with vendors, contractors, and internal stakeholders to ensure seamless execution. Regulatory Compliance: Ensure all validation protocols, reports, and supporting documentation are created, reviewed, and maintained to meet regulatory compliance requirements. Candidate Profile: Experience: 10-15+ years of validation experience within a GMP pharmaceutical aseptic/sterile fill/finish environment. Leadership: Proven leadership experience in managing validation activities for large-scale pharmaceutical projects, including engaging with senior, cross-functional stakeholders. Technical Expertise: Extensive experience in equipment validation, particularly within fill-finish processes, and the ability to lead a team of senior engineers. Availability: Able to start mid-late September, with a commitment to a 12-month contract, working onsite in Massachusetts for 40-50 hours per week as project demands dictate. This is an excellent opportunity for a seasoned validation professional to lead critical projects in a dynamic and expanding environment.
