Career Category

Job Description

Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Responsibilities

• Independently provide and/or direct the technical validation lifecycle support for Amgen Singapore Manufacturing (ASM) application and computer system environments, including manufacturing, process development, laboratory, facilities, and utilities areas.
• Develop and maintain validation procedures and data integrity programs that affect multiple organizations at ASM.
• Partner with QA to actively maintains an up to date list of Validated Computerized systems
• Work with project managers to ensure appropriate development and execution of computer validation and lifecycle requirements for site projects within schedule, budget, and quality constraints.
• Partners with QA system owners to ensure systems are maintained in a validated state and all periodic compliance activities are completed as required.
• Apply knowledge of risk based computer validation and Part 11/Annex 11 principles and practices within and outside area of expertise to a broad variety of assignments.
• Lead or support in internal and regulatory audit as functional subject matter expert (SME)  
• Lead in systems risk assessment, change controls and implementation of CAPAs or mitigation activities to closure  
• Support internal and regulatory audits.
• Collaborate with global quality and compliance teams to ensure alignment.
• Investigate isolated data integrity gaps and events and potentially systemic system issues together with other stakeholders; recommend improvements to address these events and issues.
• Keep current with Part 11, Annex 11, and computer validation trends both within Amgen and external in the pharmaceutical industry and regulatory authorities, mostly through routine participation with internal validation network interactions.

Basic Qualifications

• Degree in Engineering, Information Systems, Computer Science, or Life Sciences
• Doctorate degree & 2 years of directly related experience OR
• Master’s degree & 4 years of directly related experience OR
• Bachelor’s degree & 6 years of directly related experience OR

Relevant Experience

• 8 + years’ experience in computer systems support, project management, system ownership, and/or computer validation, particularly in the pharmaceutical industry
• Experience leading or managing regulatory or IS inspection or audits
• Prior experience or certification in ITIL, Agile or SCRUM preferred

Competencies / Skills

• In-depth knowledge of Part 11/Annex 11 computer system, data integrity and validation processes, requirements, and policies
• Knowledge and experience in application of risk based approaches to computer validation
• Excellent communications skills (written, spoken, and group presentation to various levels of the organization) as well as relationship skills
• Ability to handle multiple projects or initiatives simultaneously
• Knowledge and mastery of troubleshooting and process improvement processes,
• Ability to coach and transfer knowledge and practical concepts to other groups/ individuals for whom computer validation is not a core competency

Demonstrated skills in the following areas:

• Facilitation and collaboration
• Follow-up and completion
• Negotiation and persuasion
• Conflict resolution
• Decision-making
• Ability to work in teams