Principal Validation Engineer

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 synthetic API manufacturing process validation and cleaning validation.

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

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.

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.

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.

What we expect of you

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.