Manager Manufacturing, Single Use Systems & Validation

Manager Manufacturing, Single Use Systems & Validation

Join to apply for the Manager Manufacturing, Single Use Systems & Validation role at Bio Space
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Join Amgen's mission of serving patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—oncology, inflammation, general medicine, and rare disease—we reach millions of patients each year.

As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest single‑use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.

• Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
• Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation.
• Lead development and execution of the site's Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies.
• Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development.
• Coordinate troubleshooting and support during commissioning, qualification, start‑up, and process performance qualification of the facility.
• Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions.
• Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections.
• Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant.
• Collaborate cross‑functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• Maintain inspection readiness and support staff with audit or regulatory response strategy.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess the following qualifications.

• High school diploma/GED and 12 years of biotechnology operations or validation experience, OR
• Associate's degree and 10 years of biotechnology operations or validation experience, OR
• Bachelor's degree and 5 years of biotechnology operations or validation experience, OR
• Master's degree and 3 years of biotechnology operations or validation experience, OR
• Doctorate degree

• Educational background in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field.
• Experience leading/managing a team of direct reports in a GMP manufacturing environment.
• Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing.
• Experience in supporting regulatory…