Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
Role Description:
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 missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.
The Senior Validation Engineer will oversee strategies and documents related primarily to FDP (Finished Drug Product) product specific qualifications (eg., OQ, PQ, and/or PPQ) at contract manufacturing organizations (CMOs) located primarily in the JAPAC region, but occasionally in EU or North America. Direct experience with qualification/validation of primary and secondary packaging processes, including device / combination products is required. The candidate should have some experience and understanding of implementing statistical methods for determining appropriate sampling plans and acceptance criteria, based on level of risk. Experience with validation of synthetic API manufacturing processes is also highly desired. Prior experience with, or willingness to learn, other modalities, including biologic drug substance and aseptic drug product is also desired. The candidate should be able to travel within the JAPAC region, specifically Japan.
Roles & Responsibilities:
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.
Translate Amgen requirements into the language of the CMO
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Identify and assess validation/quality risks to enable risk-based decisions
Validation document author/approver
Oversight of packaging process qualification, device and combination product qualifications.
Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes.
Implement statistical methods to create risk based sampling plans and acceptance criteria.
Oversight of synthetic API manufacturing process validation and cleaning validation.
Aseptic processing system oversight (media fill, autoclave validation, EM)
Prepare materials/documents (playbooks) for topics to be presented during audits/inspections
Perform validation change control assessments
Review/approve validation deviations
Review/approve Master Batch Records
Perform Person in Plant activities as required
Escalate issues to Validation/Quality management, as needed
Author Validation sections of Marketing Applications
Write/review responses to regulatory questions (RTQs)
Drive Operational Excellence and Champion Change
Authority:
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.
Basic Qualifications and Experience:
Doctorate degree OR Master’s degree with 4 to 6 years of experience in process validation or a related field OR
Bachelor’s degree with 6 to 8 years of experience in process validation or a related field OR
Diploma with 10 to 12 years of experience in process validation or a related field.
Must-Have Skills:
Prior experience serving as Validation lead for NPI or tech transfer of 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
Good-to-Have Skills:
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
Desire to partner with internal and external stakeholders across teams
Understanding of industry requirements/expectations that comprise a robust Validation package.
Soft Skills:
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.
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 with 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.
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