Specialist Manufacturing – Cleaning Validation

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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 Amgens 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 sites 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.

Lets do this! Lets 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
• Masters degree and 2 years of Validation Engineering GMP Manufacturing or Process Development experience OR
• Bachelors degree and 4 years of Validation Engineering GMP Manufacturing or Process Development experience OR
• Associates 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 well 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.

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.

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.

Salary Range