Lab Validation

Equipment Validation Engineer / Specialist

We are looking for an experienced Equipment Validation Engineer / Specialist to support the qualification and validation of environmental monitoring equipment within a regulated pharmaceutical/biopharmaceutical environment.

Key Responsibilities

• Perform qualification and validation of environmental monitoring equipment, with a particular focus on air samplers and particle counters.

• Develop, review, and execute equipment qualification protocols, including IQ, OQ and PQ, as applicable.

• Ensure equipment qualification activities are performed in accordance with GMP/cGMP requirements, internal procedures, and applicable regulatory standards.

• Prepare and maintain validation documentation, including protocols, reports, test scripts, deviations, and supporting records.

• Investigate and resolve qualification or validation issues identified during protocol execution.

• Collaborate with Quality, Engineering, Manufacturing, and other relevant stakeholders to ensure timely completion of validation activities.

• Support equipment commissioning, calibration, maintenance, and change-control activities where required.

Requirements

• Hands-on experience in equipment validation and/or qualification within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.

• Demonstrated experience qualifying environmental monitoring equipment, particularly:

  • Air samplers / microbial air samplers

  • Particle counters / airborne particle counters

• Good understanding of IQ/OQ/PQ and equipment validation lifecycle principles.

• Familiarity with GMP/cGMP requirements and validation documentation.

• Strong technical documentation, problem-solving, and stakeholder-management skills.

• Degree or diploma in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline is preferred.