Specialist Manufacturing – Cleaning Validation

Specialist Manufacturing – Cleaning Validation

Career Category: Manufacturing | Location: Thousand Oaks, California (On-site, flexible commuter)

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.

What you will do

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.

The Specialist Manufacturing - Cleaning Validation will serve as a technical lead and subject matter expert for equipment cleanability and cleaning/sterilization validation. 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.

Responsibilities

• Own equipment cleanability assessments and cleaning/sterilization validation requirements for 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 and support site and network improvements.
• 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.

Basic Qualifications

• 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

Preferred Qualifications

• 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.
• Strong mathematical skills and strong Microsoft Excel skills for calculations, data analysis, and trending validation results.

What you can expect from us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is 107,545.40 USD – 145,502.60 USD. Actual salary will vary based on relevant skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan, based on eligibility, that may include:

• 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
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Application deadline: Amgen does not have an application deadline for this position; applications will be accepted until a sufficient number is received or a candidate is selected.

Sponsorship: Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Individuals with disabilities will be provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.