Sr Validation Engineer

About Amgen

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Validation Engineer

What you will do

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.

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 to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions.

The candidate should have prior experience with qualification of the following modalities, primarily: synthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP.

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.

Roles & Responsibilities:

• Translate Amgen requirements into the language of the CMO
• Identify and assess validation/quality risks to enable risk-based decisions
• Validation document author/approver
• Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes.
• 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 time zones.

What we expect of you

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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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 to 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.