Specialist Manufacturing – Cleaning Validation

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Stock-based incentives

Flexible work models

Retirement and savings plan

Job summary

Amgen Thousand Oaks is seeking a Specialist Manufacturing – Cleaning Validation to lead equipment cleanability assessments and validation activities for NPIs and existing products. You will collaborate across Manufacturing, Quality, Engineering, Process Development, and Supply Chain to ensure compliant, robust cleaning strategies.

The role requires advanced degrees with 2+ years of validation/GMP experience, strong technical writing, and the ability to work on‑site with flexible scheduling to

Qualifications

• Doctorate or Master’s with validation, GMP manufacturing, or process development experience.
• Bachelor’s with 4+ years in validation, engineering, GMP manufacturing, or process development.
• Associate’s with 8+ years in validation, engineering, GMP manufacturing, or process development.
• High school diploma with 10+ years in validation, engineering, GMP manufacturing, or process development.

Responsibilities

• Own cleaning validation requirements for NPIs and existing products, including MAC/MAR assessments.
• Lead cross-functional projects across Manufacturing, Quality, Engineering, Process Development and Supply Chain.
• Provide on‑floor troubleshooting, function testing, validation execution, deviation investigations and CAPA support.
• Develop and approve cleaning characterization and validation strategies, protocols, reports and sampling plans.
• Represent Cleaning Validation during regulatory audits and inspections and support site improvements.

Skills

Validation

GMP manufacturing

Process development

Cross-functional leadership

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

Microsoft Excel

Job description

Career Category Manufacturing Job Description

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.

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.

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.
• 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.

What we expect of you

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

Basic Qualifications

• Doctorate degree OR Master’s degree and 2 years of Validation, Engineering, GMP Manufacturing, or Process Development experience
• Bachelor’s degree and 4 years of Validation, Engineering, GMP Manufacturing, or Process Development experience
• Associate’s degree and 8 years of Validation, Engineering, GMP Manufacturing, or Process Development experience
• 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 in the area of expertise.
• Strong mathematical skills and strong Microsoft Excel skills for calculations, data analysis, and trending validation results.

What you can expect from us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
• In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities 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, 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. Refer to the Work Location Type in the job posting to see if this applies.

Salary Range 107,545.40USD -145,502.60 USD

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Equal Opportunity

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. We will ensure that individuals with disabilities are 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. Please contact us to request accommodation.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen