Senior Validation Engineer

Career Category Manufacturing Job Description Join Amgen's Mission to Serve Patients At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact. Senior Validation Engineer I What you will do General Responsible for providing technical support and leading team of validation engineers to provide technical support for commissioning, qualification, cleaning validation and validation lifecycle maintenance in ASM Establish validation strategies and procedures to align with Amgen operating standards and regulatory expectations Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met Provide SME support & represent validation for filings, audits and regulatory inspections Close interactions with Amgen’s corporate validation network to influence strategic management of the validation programs Required to own or provide subject matter expertise to SOP, deviations, corrective/preventive actions, validation schedule and change controls validation impact assessments Escalate significant validation related issues to operation management in a timely manner Lead and support site/network validated driven continuous improvement initiatives/activities Mentor and coach cross functional team members on validation technical knowledge. Drive Operational Excellence initiatives within validation workspace. Cleaning Validation Responsible for deliverables related to cleaning validation Responsible for providing cleaning validation expertise including generation/review/approval of cleaning related documents (e.g. cleaning strategy and methodology, cleaning characterization/inactivation reports, acceptance limits reports) for new product introduction Execute, lead and drive cleaning development, verification/validation activities including change control, training, generation/review/approval of protocols and reports Provide oversight of validation tasks and advice to clients on equipment validation for manufacturing process equipment, supply chain facilities and analytical laboratories Technical execution of validation tasks associated with Controlled Temperature Chamber (CTC). The chambers will include commercial off the shelf (COTS) units but may include other more complex validations as necessary Collaborate with project leads with direct accountability for project milestones related to validation deliverables for commissioning and qualification. Projects can range from equipment upgrades to large-scale capital projects and facility construction. Validation Lifecycle Maintenance Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and system All listed tasks and responsibilities are deemed as essential functions to this full-time position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. What we expect of you Doctorate Degree Master’s degree in engineering and 2 years of experience in pharmaceutical company or GMP environment OR Bachelor’s degree in engineering and 4 years of experience in pharmaceutical company or GMP environment OR Diploma in Engineering, and 8 years of experience in pharmaceutical company or GMP environment Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and