JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

BASIC QUALIFICATIONS:

Doctorate degree in Engineering and 2 years of validation experience.
OR
Master’s degree in Engineering and 4 years of validation experience
OR
Bachelor’s degree in Engineering and 6 years of validation experience

PREFERRED QUALIFICATIONS:

• Expertise in Commissioning, Qualification and Validation: Extensive knowledge of the Validation Program Lifecycle Including presenting and defending qualification studies to regulatory / compliance auditors.
• Strong experience with GMP critical utilities, HVAC, temperature control storage and/or facilities.
• Industry Experience: Proven CQV background in the pharmaceutical industry
• Regulatory Knowledge: Comprehensive understanding of regulatory requirements and industry standards (ASTM-2500E, GMP Annex 1, FDA Guidelines).
• A plus if a member of a relevant professional association (e.g., ISPE, PDA, ASHRAE, etc.)
• Project Management: Experience managing complex projects and leading cross-functional teams. Ability to delegate, motivate, and communicate the vision for the validation program.
• Analytical Skills: Strong problem-solving abilities with the capacity to apply scientific and engineering principles creatively.
• Leadership Skills: Demonstrated leadership, decision-making, and team-building capabilities. Experience managing contractors and vendors.
• Communication Skills: Excellent verbal and written communication skills in English

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will be a key expert leading the Commissioning, Qualification, and Validation (CQV) of Site Facilities, HVAC and Critical Utilities of the AML LLC - PR operations. Your work will ensure the highest standards in our manufacturing site, making a tangible impact on global health.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Oversee the CQV planning, execution and documentation for Facilities, HVAC and Critical Utilities: Manage complex projects involving the planning, design, construction, maintenance, and modification of critical systems. Decide the extent of validation required applying risk / science-based strategies documented through master plans, protocols technical assessments, as well as addressing exceptional conditions. Provide prompt and sound technical support for GMP operations within the Site.
• Innovate CQV for GMP Facilities, Critical Utilities and HVAC: Apply industry-wide validation knowledge to develop sound commissioning qualifications and validation approaches for our GMP facilities.
• Team Leadership: Oversee and coordinate a team of engineers and technicians, potentially supervising staff or project resources directly, fostering a culture of excellence and continuous improvement.
• Cross-Functional Collaboration: Partner with engineering, manufacturing, process development, and quality assurance teams to develop requirements for complex processes and facility modifications to ensure smooth project delivery.
• Regulatory Compliance: Ensure validation strategies and system qualification packages compliance with global regulatory requirements including but not limited to ASTM-2500E, ISO-14644, EMA GMP Annex 1, and FDA Guidelines. Participates in internal/external audits and inspections.