Specialist Manufacturing – Cleaning Validation

Amgen • Thousand Oaks, CA

6d • Onsite

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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. Specialist Manufacturing – Cleaning Validation What you will do Do you enjoy solving technical challenges in a multi-product manufacturing environment? Are you motivated by leading complex cross-functional projects and using data to improve systems that protect product quality and patients? If you have a passion for cleaning validation and want to contribute to Amgen’s mission to serve patients - every patient, every time - then check out this exciting opportunity. The position is within Drug Substance Supply at Amgen Thousand Oaks (ATO), supporting the site’s multi-product drug substance manufacturing operations. ATO supports products from clinical development through commercial production. The Manufacturing Programs organization works across Manufacturing, Quality, Engineering, Supply Chain, and Process Development to support new product introductions, equipment and technology changes, continuous improvement, and reliable operations. Let’s do this! Let’s change the world! In this vital role, the Specialist Manufacturing - Cleaning Validation will serve as a technical lead and subject matter expert for equipment cleanability and cleaning/sterilization validation within the Manufacturing Programs organization in Drug Substance Supply at Amgen Thousand Oaks (ATO). The role owns cleaning validation requirements for new product introductions (NPIs) and existing products, including MAC/MAR calculations. As an individual contributor, the Specialist will lead complex cross-functional projects, provide technical support to manufacturing operations, and use data to guide compliant solutions and continuous improvement. The role also supports commissioning, qualification, audits, and routine monitoring to maintain and confirm the validated state of equipment.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Validation, Engineering, GMP Manufacturing, or Process Development experience OR Bachelor’s degree and 4 years of Validation, Engineering, GMP Manufacturing, or Process Development experience OR Associate’s degree and 8 years of Validation, Engineering, GMP Manufacturing, or Process Development experience OR High school diploma/GED and 10 years of Validation, Engineering, GMP Manufacturing, or Process Development experience

Nice To Haves

• Demonstrated ability to lead complex cross-functional projects, define milestones, manage competing priorities, and deliver results.
• Strong technical writing and presentation skills; able to analyze data and communicate recommendations to technical teams, senior leaders, and inspectors.
• Expertise in equipment cleanability, equipment qualification, cleaning and sterilization validation, and MAC/MAR in a biologics facility, including developing validation strategies and procedures.
• Experience developing, executing, reviewing, and approving characterization and validation strategies, protocols, reports, acceptance limits, and sampling plans.
• Experience providing technical support in GMP manufacturing, including on-floor troubleshooting, function testing, and quality investigations.
• Knowledge of EudraLex Annex 15, FDA Title 21 CFR Parts 210 and 211, ASTM E2500, and ICH Q7
• Experience supporting regulatory submissions and inspections, change controls, CAPAs, and deviation investigations; ability to coach and train colleagues in the area of expertise.
• Strong mathematical skills and strong Microsoft Excel skills for calculations, data analysis, and trending validation results.

Responsibilities

• Own equipment cleanability assessments and cleaning/sterilization validation requirements for new product introductions (NPIs) and existing products, including MAC/MAR assessments.
• Lead complex cross-functional projects from scope and planning through execution and implementation, coordinating with Manufacturing, Quality, Engineering, Process Development, and Supply Chain.
• Provide technical support to manufacturing operations, including on-floor troubleshooting, function testing, validation execution, major deviation investigation support, and implementation of corrective and preventive actions.
• Develop, execute, review, and approve cleaning characterization and validation strategies, protocols, reports, acceptance limits, and sampling plans.
• Assess cleanability and validation impacts for new products, equipment, process changes, and technologies; support commissioning and qualification of manufacturing equipment and cleaning/sterilization processes.
• Lead and support cleaning validation quality records, including change controls, CAPAs, deviations, and effectiveness checks, through resolution and closure.
• Maintain applicable site validation plans, cleaning validation status, and routine monitoring; analyze data, identify trends, and recommend actions that preserve the validated state.
• Represent Cleaning Validation during regulatory audits and inspections; present technical findings, support site and network improvements. and coach or Mentor and train colleagues in the area of expertise.
• Ability to work on-site (flexible commuter)
• Available to work various times of day (day, swing, graves, weekends, holidays) as instructed by the production schedule to execute function-testing, validation execution and project tasks with minimal disruption to operations.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed