Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities

Amgen; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen is seeking a Principal Validation Engineer to lead the Commissioning, Qualification, and Validation of Site Facilities, HVAC, and Critical Utilities. This role ensures compliance with regulatory standards and involves collaboration across multiple teams. The ideal candidate will have a strong engineering background and validation experience in the pharma industry. Join Amgen to make a difference in patients' lives while advancing your career.

Benefits

Health plans

Retirement plans

Bonuses

Stock incentives

Flexible work arrangements

Qualifications

• 2 years validation experience with Doctorate, 4 years with Master's, or 6 years with Bachelor's.
• Extensive knowledge of Validation Lifecycle and regulatory standards.

Responsibilities

• Manage CQV planning, execution, and documentation for Facilities, HVAC, and Critical Utilities.
• Collaborate with engineering, manufacturing, process development, and QA teams.

Skills

Project management

Leadership

Communication

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Job description

Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities

Join Amgen as a Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities.

About Amgen

Since 1980, Amgen has pioneered biotech innovations in Oncology, Inflammation, General Medicine, and Rare Diseases, impacting millions of patients annually. Our culture is collaborative, innovative, and science-driven. Join us to make a difference in patients' lives and advance your career.

Role Overview

This role involves leading the Commissioning, Qualification, and Validation (CQV) of Site Facilities, HVAC, and Critical Utilities at AML LLC - PR operations, ensuring compliance with high standards and regulatory requirements.

Key Responsibilities

• Manage CQV planning, execution, and documentation for Facilities, HVAC, and Critical Utilities, including project management and technical support.
• Develop and innovate validation strategies for GMP facilities and utilities.
• Lead and coordinate a team of engineers and technicians, fostering continuous improvement.
• Collaborate cross-functionally with engineering, manufacturing, process development, and QA teams.
• Ensure compliance with global regulatory standards (e.g., ASTM-2500E, ISO-14644, EMA GMP Annex 1, FDA Guidelines) and participate in audits.

Qualifications

Basic Qualifications

• Doctorate in Engineering + 2 years validation experience OR
• Master’s in Engineering + 4 years validation experience OR
• Bachelor’s in Engineering + 6 years validation experience

Preferred Qualifications

• Extensive knowledge of Validation Lifecycle and experience defending qualification studies to auditors.
• Strong background in GMP critical utilities, HVAC, and facilities.
• Proven CQV experience in pharma industry.
• Understanding of regulatory standards (ASTM-2500E, GMP Annex 1, FDA).
• Professional memberships (e.g., ISPE, PDA, ASHRAE) are a plus.
• Project management and leadership skills, with experience managing cross-functional teams and vendors.
• Excellent communication skills in English.

What We Offer

Amgen supports your professional growth with comprehensive benefits, including health plans, retirement plans, bonuses, stock incentives, time-off, and flexible work arrangements.

Join Us

Apply now at careers.amgen.com and help us improve lives worldwide.

We are committed to diversity and inclusion, providing accommodations for applicants with disabilities.