Principal Validation Engineer

At Amgen, our shared mission to serve patients living with serious illnesses guides everything we do. By combining science, innovation, and collaboration, we work to address some of the world's toughest diseases and improve the lives of millions of people worldwide.

Amgen harnesses the best of biology and technology to help make people's lives easier, fuller, and longer. Every role contributes to that mission, creating meaningful opportunities to lead, innovate, and make a lasting impact.

If you're motivated by complex challenges, strategic thinking, and the opportunity to influence outcomes, we encourage you to explore a career with Amgen.

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations.   You will make key contributions to fulfill Amgen’s mission of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.    

The Principal Validation Engineer will oversee validation strategies and documents related primarily to Synthetic Drug Substance (DS / API) and Biologic Aseptically Filled Drug Product (DP).  Experience with Finished Drug Product (FDP) product would be considered a valuable additional skill but is not required. The principal validation engineer will serve on the core tech transfer team and will be responsible for ensuring compliant Process Validation and Cleaning Validation strategies at the synthetic DS and biologic DP contract manufacturing organizations (CMOs) site.  For FDP sites, if applicable, the validation engineer will ensure a robust qualification strategy (eg., OQ, PQ, and/or PPQ) is implemented at the CMO.  The CMO sites will be located primarily in the JAPAC region (China, India and Japan), but some occasional support in EU or North America, may be required. 

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  Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc.  Project teams will include tech transfers, new product introductions, and ongoing validation maintenance activities.

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  Translate Amgen requirements into the language of the CMO.

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  Identify and assess validation/quality risks to enable risk-based decisions.

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  Validation document author/approver.

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  Oversight of synthetic API manufacturing process validation and cleaning validation.

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  Oversight of aseptic DP filling process validation and cleaning validation, as well as aseptic processing and sterilization validation oversight (media fill, autoclave validation, EM)

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  Oversight of packaging process qualification, device and combination product qualifications.

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  Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes.

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  Implement statistical methods to create risk-based sampling plans and acceptance criteria. 

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  Prepare materials/documents (playbooks) for topics to be presented during audits/inspections.

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  Perform validation change control assessments.

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  Review/approve validation deviations.

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  Review/approve Master Batch Records.

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  Escalate issues to Validation/Quality management, as needed.

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  Author Validation sections of Marketing Applications.

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  Write/review responses to regulatory questions (RTQs).

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  Drive Operational Excellence and Champion Change.

• Determine outcome of validation activities

• Decision to approve or reject validation documentation

• Provide input on Validation position on related topics and strategy for the site

• Decision to approve Master batch Records

This role may require working in shifts or extended hours within the same shift to support global timezones.

• Doctorate degree with 2 years of directly related experience; or

• Master's degree with 6 years of directly related experience; or

• Bachelor's degree with 8 years of directly related experience.

• Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. 

• Relevant experience in validation of synthetic drug substance manufacturing.

• Relevant experience in validation of aseptically filled drug product manufacturing processes.

• Relevant experience in qualification of finished drug product and packaging processes. 

• Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

• Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them 

• Working foundation in cleaning validation and aseptic process simulation.

• Experience in resolving complex deviations associated with validation studies.

• Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

• Proven experience in designing and/or improving processes at conceptual level 

• Understanding of industry requirements/expectations that comprise a robust Validation package. 

• Excellent analytical and troubleshooting skills.

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• High degree of initiative and self-motivation.

• Ability to manage multiple priorities successfully.

• Team-oriented, with a focus on achieving team goals

• Strong presentation and public speaking skills.

At Amgen, you'll work alongside talented colleagues in an environment that values innovation, collaboration, and growth. We are committed to helping you develop your career while contributing to work that matters for patients.

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 as we 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.