Title: GMP Equipment Validation Specialist

Location Lenexa, KS

What you will do As a GMP Equipment Validation Specialist at ICON you will be responsible for the ongoing qualification of equipment and controlled environments supporting 2 GMP pharmacies and a QC Laboratory. This includes cleanrooms, refrigerators, temperature mapping, IQ/OQ/PQ activities, change controls, audit support, and onboarding new equipment and controlled spaces. The specialist will be based in Lenexa, work closely with the on-site teams, and provide remote support to the GMP pharmacy in San Antonio. The role requires someone who can manage validation activities independently while partnering with Quality, Facilities, Pharmacy, and laboratory stakeholders.

Key responsibilities include:

• Conducting validation and qualification activities for equipment, controlled environments, and related processes used in GMP pharmacy and laboratory operations to ensure compliance with regulatory requirements.
• Collaborating with cross-functional teams to define validation strategies and documentation standards.
• Overseeing the execution of validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Supporting temperature-mapping activities for cleanrooms, refrigerators, and other temperature-controlled equipment.
• Providing technical guidance on equipment validation and qualification methodologies and best practices to enhance operational efficiency.
• Assisting in the identification and remediation of issues related to equipment qualification, controlled environments, and regulatory compliance.
• Supporting change-control activities and responding to audits related to validated equipment and facilities.

Your Profile: You will bring relevant scientific operations experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor’s degree in a relevant field such as life sciences, engineering, or a related technical discipline.
• At least one year of GMP equipment validation or qualification experience within the pharmaceutical, laboratory, or clinical research industry, with a solid understanding of applicable regulatory requirements.
• Experience with IQ/OQ/PQ protocols and validation documentation.
• Experience with temperature mapping, cleanrooms, controlled environments, or temperature-controlled equipment is preferred.
• Strong analytical and problem-solving skills with keen attention to detail.
• Ability to independently manage validation activities and multiple projects while collaborating with cross-functional teams.
• Excellent communication skills, with the ability to clearly convey technical information to non-technical stakeholders.