Engineer, Validations

Your Role

The Validation Engineer I is responsible for supporting commissioning, qualification, and validation activities for GMP equipment, utilities, facilities, and computerized systems. This role assists in the development and execution of validation protocols, technical reports, and related documentation to ensure compliance with company procedures, regulatory requirements, and industry standards. The Validation Engineer will work cross-functionally with Quality Assurance, Manufacturing, Facilities and Engineering, Supply Chain and external vendors to support validation initiatives and maintain the validated state of GMP systems.

Key Responsibilities

• Support qualification and validation activities for GMP equipment, utilities, and facilities.
• Review User Requirement Specification (URS) and/or Requirement Specification documents for equipment/systems and processes.
• Generate and execute CQV (Commissioning, Qualification, and Validation) protocols and final reports that comply with corporate and regulatory requirements for GMP equipment/system and utilities, including: Palletanks, Temperature Control Units, Controlled Temperature Chambers (Cold Rooms, Freezer, Refrigerators, Incubators), Compressed Gases, Air Handling/Roof Top Units, WFI System, Analytical Instruments.
• Review equipment documentation, including P&IDs, user manuals, calibration records, and engineering drawings.
• Perform gap analysis of vendor provided protocols.
• Perform temperature mapping requalification activities of GMP equipment (autoclave, depyrogenation oven, and controlled temperature chambers).
• Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
• Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
• Ensure any discrepancies to protocols and/or to acceptance criteria are adequately addressed.
• Participate and support SAT activities.
• Ensure validation documentation complies with cGMP requirements, FDA regulations, EU GMP guidelines, GAMP 5 principles, and company procedures.
• Maintain accurate and organized validation records in electronic and paper-based systems.

Minimum Qualifications

• BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
• 2-4 years of experience in validation or related pharmaceutical/biotechnology industry experience.
• Experience supporting equipment qualification and utility validation activities is preferred.
• Familiarity with IQ/OQ/PQ execution and GMP documentation practices.
• Experience working within FDA-regulated or other regulated manufacturing environments is preferred.
• Experience with using temperature mapping systems (e.g., Ellab ValSuite, Lives, or similar systems).

Position Type/Expected Hours of Work

This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Who you are

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence. You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.