Specialist Manufacturing – Cleaning Validation

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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.

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.

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 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 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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.

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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.

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Salary Range

107,545.40USD -145,502.60 USD