The Sr. Engineer I, Validation will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes. Establish validation protocols, risk assessments, and qualification plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors. Executes multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders. Work collaboratively with peers within the cross-functional teams (Facilities and Engineering, IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies. With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful. Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works to address perceived deficiencies. Foster a culture of compliance, quality, and continuous improvement within the validation team. Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance. Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes. Collaborate with cross-functional teams to address any findings related to validation and implement corrective actions as necessary. Oversee the qualification and validation of laboratory instruments, equipment, and systems, including but not limited to analytical instruments, autoclaves, and environmental monitoring systems. Implement risk-based validation approaches to optimize processes and reduce validation cycle times while maintaining the highest quality. Identify opportunities for process optimization and efficiency improvements within the validation function, collaborating with cross-functional teams as needed. Develop and deliver training programs for validation team members to enhance their capabilities and knowledge of validation principles and practices.