Manager, MES & PI Systems

The ideal candidate will have a proven track record of leadership in technology-driven environments for the Manufacturing Technology area and has a passion for fostering continuous improvement and service excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in end to end technology operations support in a highly regulated environment and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role plays a critical role in maintaining manufacturing uptime, product quality, and regulatory compliance while driving operational excellence and continuous improvement.

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 and Experience:

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

Functional Skills:

Must-Have Skills (Not more than 3 to 4):

• Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation
• Demonstrated hands on experience managing and being a system owner of MES systems and/or PIHistorian system
• Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent.
• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships.
• Experience in applying technology best practice methodologies: Scaled Agile (SAFe), ITIL, etc.
• Demonstrate deep understanding of biopharmaceutical industry, GMP regulated environment

Good-to-Have Skills:

• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in the software development lifecycle.
• Experience using and adoption of Scaled Agile Framework (SAFe)
• Strong analytic/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business stakeholders
• Broad working knowledge of key IS domains and layers

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• ITIL (preferred)
• Scaled Agile Framework (SAFe) for Teams

Soft Skills:

• Excellent leadership and team management skills.
• Strong transformation and change management experience.
• Exceptional collaboration and communication skills.
• 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.
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams

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.

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