Senior Validation Engineer

Amgen Inc. (IR); Hyderabad; On-site; INR 1,800,000 - 2,500,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Senior Validation Engineer to provide quality oversight of analytical method validation, transfer and cleaning-validation activities across CMOs supporting Amgen's global supply network.

You will review validation protocols, assess data integrity and regulatory compliance, and ensure robust technical justification. The role requires strong GMP knowledge, hands‑on experience with API/drug substance validation, and the ability to collaborate across global teams and

Qualifications

• Doctorate or Master’s with 4–6 years of experience in process validation or a related field.
• Bachelor’s with 6–8 years of experience in process validation or a related field.
• Diploma with 10–12 years of experience in process validation or a related field.

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.

Skills

Validation lead

NPI transfer

cGMP

Data integrity

Analytical methods

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Diploma

Job description

Career Category Quality Job Description Job Description

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

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
• Bachelor’s degree with 6 to 8 years of experience in process validation or a related field
• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen