Lead Engineer

Role: Lead Engineer in Equipment Commissioning and Qualification (ECQ) supporting biopharma manufacturing facilities, ensuring equipment, utilities, and facilities meet compliance and validation standards. Responsibilities: manage commissioning and qualification projects, develop protocols, oversee vendor activities, support validation and change management processes, and ensure systems remain qualified; lead project execution including scheduling, installation, and turnover; provide technical support for equipment and systems; ensure regulatory compliance, participate in deviation investigations. Qualifications: BS in Engineering or Science preferred, with at least 4 years' GMP experience, 3 years supporting equipment/utility qualification, and 2 years in project management; strong knowledge of cGMP, GXP, 21CFR part 11, and pharmaceutical manufacturing systems; excellent communication, organizational, and multi-tasking skills; proficient in MS Office and database tools. High-Value: focus on equipment, utilities, facilities validation in a regulated biopharma environment; supporting multi-use sites within a life sciences manufacturing context. Work Setup: likely on-site at multi-use facilities, with potential for hybrid arrangement; travel not specified.