Senior Validation Engineer

Senior Validation Engineer

In this role, you will serve patients through collaboration with Amgen's global Quality, Manufacturing, Process Development, Analytical Sciences, and Supply Chain organizations, while providing quality oversight of Contract Manufacturing Organizations (CMOs) supporting Amgen's global supply network.

The primary focus of this position is providing Quality oversight and technical leadership for analytical method lifecycle activities at external manufacturing partners, including analytical method validation, method transfer, verification, and ongoing performance monitoring. The role will be responsible for reviewing and approving analytical validation and transfer protocols and reports, assessing scientific rationale and statistical approaches, evaluating data integrity, and conducting source data verification to ensure compliance with regulatory requirements and Amgen expectations.

In addition, the role will provide oversight and guidance for cleaning and process validation programs supporting synthetic API and peptide manufacturing operations, including: evaluation of cleaning strategies, acceptance criteria, sampling approaches, analytical methods, validation strategies and corresponding protocols, reports, and periodic review activities.

A successful candidate will possess strong technical expertise in analytical method validation and transfer, a thorough understanding of GMP and data integrity requirements, and direct experience supporting manufacturing activities. Experience with synthetic API and peptide manufacturing operations is highly desirable. The candidate should be comfortable working across multiple global time zones and may be required to travel periodically to CMO sites within the JAPAC region and globally as needed. Prior experience with, or willingness to learn, other modalities, including biologic drug substance, aseptic drug product, and final product packaging is also desired.

Roles & Responsibilities

Provide Quality oversight of analytical method validation, verification, qualification, and transfer activities at CMOs and approval of supporting documentation.

Evaluate method validation designs, statistical approaches, acceptance criteria, and scientific justification to ensure compliance with regulatory expectations.

Perform detailed assessments of analytical data packages, including source data verification, audit trail review, and data integrity evaluations.

Assess analytical investigations, deviations, OOS/OOT events, and CAPAs related to method validation and transfer activities.

Provide technical oversight and guidance for cleaning validation programs supporting synthetic API and peptide manufacturing operations. Assess cleaning validation strategies using risk-based and science-based approaches.

Review and assess cleaning validation protocols, reports, sampling plans, analytical test methods, acceptance limits, and periodic review reports.

Support process validation and PPQ activities for synthetic API and peptide manufacturing processes. Review process validation protocols, reports, continued process verification data, and associated risk assessments.

Translate Amgen quality and validation requirements into practical expectations for CMOs.

Identify, assess, and communicate validation and quality risks to support informed decision-making.

Review and provide technical and compliance expertise for validation deviations, change controls, and investigations.

Perform Person-in-Plant activities as required.

Escalate significant quality, compliance, validation, or data integrity concerns to management.

Drive continuous improvement initiatives and promote operational excellence across the external manufacturing network.

Authority

Determine acceptability of analytical validation, method transfer, cleaning validation, and process validation activities. Approve or reject validation and qualification documentation.

Provide Quality recommendations regarding validation strategies and compliance decisions.

Assess adequacy of investigations, CAPAs, and change controls related to validation activities.

Recommend escalation and remediation actions for significant compliance or quality risks.

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 drug substance or API materials in a manufacturing environment.

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:

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.