Job Information
Amgen Validation Engineer in Holly Springs, North Carolina
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 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.
Validation Engineer
Live
What you will do
Let’s do this! Let’s change the world! In this vital role the Engineer-Validation will serve as a subject matter expert (SME) and support 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 validation plans, 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:
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 support 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 plans 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 dedicated professional we seek is a strong communicator with these qualifications.
Basic Qualifications:
High school diploma/GED and 8 years of Validation or Engineering experience OR
Associate’s degree and 6 years of Validation or Engineering experience OR
Bachelor’s degree and 2 years of Validation or Engineering experience OR
Master’s degree
Preferred Qualifications:
Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff.
Experience in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility.
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.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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 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 accommodatio