Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities

Amgen SA; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming lives through innovative biotechnological solutions. As a Principal Validation Engineer, you will play a pivotal role in ensuring the highest standards of quality and compliance in critical utilities and HVAC systems. Your expertise will not only enhance operational efficiency but also contribute significantly to the health and well-being of patients worldwide. With a collaborative culture and a commitment to professional growth, this role offers the opportunity to make a lasting impact while advancing your career in the dynamic biotech industry.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Qualifications

• Expert in CQV for HVAC and Critical Utilities.
• Strong background in regulatory compliance and validation strategies.
• Proven experience in managing complex engineering projects.

Responsibilities

• Lead CQV planning and execution for critical systems.
• Collaborate with cross-functional teams for project delivery.
• Ensure compliance with global regulatory requirements.

Skills

Commissioning

Qualification

Validation

Project Management

Analytical Skills

Leadership Skills

Communication Skills

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Tools

GMP Standards

ISO-14644

ASTM-2500E

Job description

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.

Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Principal Validation Engineer professional we seek is a collaborative individual contributor leader with these qualifications.

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 can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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