Manufacturing Manager Programs ​ – Cleaning Validation

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION? 

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. 

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. 

Manufacturing Manager Programs ​ – CleaningValidation 

Live 

What you will do 

Let’s do this. Let’s change the world. In this vitalrole the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the developmentandimplementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.  

Responsibilities: 

• Lead a team responsible for implementing andmaintaining the facility cleaning validation andsterilizationprogram. 

• Provide technical support and domainexpertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC 

• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment 

• Supply cleaning/sterilization validationexpertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports) 

• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met 

• Furnish technicalassistance and represent validation for regulatory filings, audits, and inspections 

• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems 

• Support site/network validation driven continuous improvement initiatives 

Win 

What we expect of you 

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

Basic Qualifications 

Doctorate degreeOR  

Master’s degree and3 years ofValidation orEngineering experienceOR  

Bachelor’s degree and5 years ofValidation or Engineering experienceOR  

Associate’s degree and 10 years of Validation or Engineering experienceOR 

High school diploma/GED and 12 years of Validation or Engineering experience 

AND In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects,prograns, or directing the allocationor resources. Your managerial experience may run concurrently with the required technical experience referenced above 

Preferred Qualifications 

• Experience managing staff executing technical skills in a safe and compliant manner. 

• Proficient technical writing and presentations skillsso as tocollaborate with technical and senior management staff 

• Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility 

• Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration 

• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC) 

• Knowledge of RegulationsEudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7 

• Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans 

Thrive 

Some of the vast rewards of working here  

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.  

• Full support and career-development resources to expand your skills, enhance yourexpertise, and maximize your potential along your career journey 

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act 

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor 

Apply now 

for a career that defies imagination 

Objects in your future are closer than they appear 

careers.amgen.com 

#AmgenNorthCarolina 

Equal Opportunity Statement 

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. 

We will ensure that individuals with disabilities are provideda reasonable accommodation toparticipate 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 requestan accommodation. 

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment.In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualifyon the basis of a medical reason or asincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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