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 creative 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 :

The role will be part of the Manufacturing Site Technology Sustainment team that provides follow the sun support to the technology capabilities deployed at the Manufacturing sites that positively impacts business outcomes. This individual will be responsible for developing and leading a highly talented team that is built for delivering best in class operational support.

Roles & Responsibilities :

- Serve as System Owner for Manufacturing Execution System (MES) and PIHistorian, ensuring reliability, data integrity, and continuous GMP compliance.
- Execute configuration and system changes under formal change control to optimize performance while maintaining validated state.
- Ensure system documentation, configuration records, and validation deliverables remain inspection-ready at all times.
- Ancillary support to internal and external audits, inspections, and data integrity assessments.
- Maintain alignment with global computer systems validation (CSV) and Annex 11 / 21 CFR Part 11 requirements.
- Provide complex functional support to RunOps team.
- Facilitate escalation and resolution of complex system issues with global product owner and/or application vendor as needed.
- In collaboration with business performance, OE/CI Analyst, site PM, scrum master, to effectively schedule,



communicate and implement changes to sites.
- Provide SME inputs to support root cause analysis and implement corrective/preventive actions (CAPA) to ensure system reliability.
- Monitor manufacturing system performance and proactively identify opportunities to improve system efficiency and user experience.

Basic Qualifications :

- Any degree with 8 - 13 years of experience in Business, Engineering, IT or related field.

Tech Stack & Skills :

- Must-Have : Experience managing technology initiatives, System ownership of MES/PIHistorian, People management, Scaled Agile (SAFe), ITIL, GMP regulated environment.
- Good-to-Have : Software development lifecycle, Analytical/critical-thinking, IS governance practices.

Shift Information :

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

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.

Location : Hyderabad, Telangana.

Job Type : Full time.

Note : For your candidature to be considered on this job, you need to apply necessarily on the company's redirected page of this job. Please make sure you apply on the redirected page as well.

📌 Amgen - Manager - MES & PI Systems (India)
🏢 AMGEN
📍 India