GMP Equipment Validation Specialist

About the Role

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.

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.