GMP Equipment Validation Specialist — Elevate Compliance

ICON

Lenexa (KS)

On-site

USD 70,000 - 90,000

Full time

14 days+

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Job summary

ICON in Lenexa, KS is seeking a GMP Equipment Validation Specialist to lead qualification activities for equipment and controlled environments supporting GMP pharmacies and a QC Laboratory. The role involves IQ/OQ/PQ execution, temperature mapping, and collaboration with Quality, Facilities, Pharmacy, and Lab teams.

The ideal candidate has a life sciences or engineering background with at least 1 year of GMP validation experience and strong attention to detail.

Qualifications

Bachelor’s degree in life sciences, engineering or related technical field.
At least 1 year GMP equipment validation/qualification experience.
Experience with IQ/OQ/PQ protocols and qualification documentation.
Experience with temperature mapping, cleanrooms or controlled environments preferred.

Responsibilities

Conduct validation and qualification activities for equipment and controlled environments in GMP pharmacy and lab operations.
Collaborate with cross-functional teams to define validation strategies and documentation standards.
Oversee execution of IQ/OQ/PQ protocols and affect proper validation documentation.
Support temperature-mapping activities for cleanrooms, refrigerators, and temperature-controlled equipment.
Provide guidance on validation methods to enhance operational efficiency.
Assist in issue identification and remediation related to equipment qualification and regulatory compliance.