Description

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 and 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 Handing/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.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $92,800 - $116,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.