Senior Validation Engineer

ABOUT AMGEN

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.

ABOUT THE ROLE

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
• 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. 

Functional Skills:

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.