Manufacturing Manager ProgramsCleaning Validation

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total rewards

Career development

Inclusive culture

Job summary

Amgen in North Carolina seeks a Senior Engineer-Validation to lead the development and execution of the site validation strategy at the ANC manufacturing facility. You will supervise a team, drive cleaning/sterilization validation, qualification programs, and ensure regulatory alignment across projects and audits while advancing continuous improvement initiatives.

This role requires collaboration with Manufacturing, Quality, and Process Development, strong technical writing, and a track record

Qualifications

• Doctorate or equivalent with leadership/managerial experience.
• Experience directly managing people and leading teams, projects, or resources.
• Experience in validation/engineering for pharmaceuticals.
• Knowledge of regulatory guidelines (FDA 21 CFR Part 210/211, ICH Q7, ASTM E2500).

Responsibilities

• Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program.
• Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities at ANC.
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment.
• Furnish technical documentation and review/approval of cleaning-related documents (e.g., characterization/inactivation reports, acceptance limits reports).

Skills

Leadership

People management

Project management

Technical writing

Validation experience

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

Manufacturing Manager Programs Cleaning Validation

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 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 Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX 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.

Live

What you will do

Lets do this. Lets change the world. In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation 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 sites 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 and maintaining the facility cleaning validation and sterilizationprogram.
• Provide technical support and domain expertise 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 validation expertise 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 technical assistance 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 we seekwill possess these qualifications.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 3 years of Validation or Engineering experienceOR
• Bachelors degree and 5 years of Validation or Engineering experience OR
• Associates degree and 10 years of Validation or Engineering experience OR
• 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 allocation or 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 skills so 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 Regulations Eudralex 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 your expertise, 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

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 provided a 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 an 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 qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.