Validation Lead

Amgen Inc. (IR); Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amgen seeks a Validation Lead in Hyderabad to oversee validation of data platforms and software solutions. You will ensure IQ/OQ validation, documentation, and SOP compliance, enabling teams to deploy validated products.

The role requires GMP-regulated validation experience, cross-functional collaboration with QA, RunOps, engineering and product teams, and the ability to drive timely validation with strong quality and traceability.

Qualifications

• 2+ years validation in GMP-regulated environments.
• 5–9 years testing with 2+ years validation mandatory.
• Experience leading software validation projects.
• Proficiency in IQ/OQ/PQ validation documents.
• Familiarity with computer system validation.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork.

Responsibilities

• Plan, coordinate, and lead validation activities for data platforms and software applications.
• Develop, review, and approve Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.
• Ensure validation strategies meet regulatory requirements and company standards.
• Write, review, and approve IQ, OQ, and Computer System Validation documents.
• Stay updated on SOP changes and align validation practices with evolving standards.
• Collaborate with QA, system owners, business owners, RunOps, engineering, and platform teams.
• Track progress and ensure validation activities align with project plan.
• Ensure proper documentation including deviations, change control, and non-conformance management.
• Identify opportunities for process improvements in validation activities.

Skills

Validation

GMP validation

Software validation

IQ/OQ/PQ docs

Problem solving

Communication

Education

Bachelor's/Master's in CS/Engineering

Job description

Career Category Information Systems Job Description Validation Lead Role Name: Validation Lead Department Name: Enterprise Engineering and Analytics (EEA) Role GCF: 4 Job Family: Software Development Engineer-Test II Hiring Manager Name: Asha Rani

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: We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant.

Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams.

Functional Skills

Must-Have Skills

• 2+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
• 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory.
• Experience leading software validation projects.
• Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.
• Familiarity with computer system validation and software validation is a plus.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork skills.

Good-to-Have Skills

• Experience with automated and computer-controlled systems validation (21 CFR Part 11)

Education and Professional Certifications

Bachelor’s/Masters degree in computer science and engineering preferred, other Engineering field is considered

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. Ability to learn quickly, be organized and detail oriented. 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.

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