Calibration Technician - Pharmaceutical Manufacturing bei SOKOL GxP Services

Description

SOKOL GxP Services is seeking a hands-on Calibration Technician to support laboratory and manufacturing equipment within a GMP-regulated pharmaceutical and clinical manufacturing environment in Warren, NJ.

This position focuses on calibration, preventive maintenance, requalification of temperature-controlled equipment, and ensuring compliance with FDA regulations, cGMP standards, and ALCOA+ data integrity principles.

Key Responsibilities

• Perform equipment calibration, preventive maintenance (PM), troubleshooting, and performance verification using CMMS systems (e.g., Maximo or Blue Mountain)
• Execute requalification of Controlled Temperature Units (refrigerators, freezers including -20°C / -80°C, incubators, cryotanks, cryopods, storage rooms)
• Review and approve vendor calibration and maintenance documentation
• Enter and maintain records in CMMS systems
• Escort and supervise vendors performing calibration and repair services
• Support deviations, investigations, and CAPA activities related to calibration
• Author and revise calibration and maintenance SOPs
• Maintain compliance with cGMP, Good Documentation Practices, and ALCOA+ principles
• Support audit readiness activities
• Perform equipment inventory and assist with planning/scheduling

Requirements

• Minimum 3 years of experience in an FDA-regulated pharmaceutical or biotech environment
• Hands-on experience calibrating laboratory or manufacturing equipment
• Experience working with CMMS systems (Maximo, Blue Mountain, or similar)
• Strong understanding of cGMP and documentation standards
• Ability to troubleshoot and work independently
• Proficiency in Microsoft Office

High School Diploma, Associate’s, or Bachelor’s degree accepted.

Preferred Experience

• Temperature mapping / controlled temperature unit requalification
• Experience in clinical manufacturing environments
• Experience supporting deviations and investigations

Work Environment

• Laboratory and manufacturing settings (PPE required)
• May support multiple local sites
• Occasional lifting up to 25 lbs
• On-call support as required

Benefits

• $22.42 - $28.48 an hour
• Health, dental, and vision insurance
• 401(k) plan with company match
• Paid company holidays
• Interest free relocation assistance loan
• Continuous professional development and training opportunities through SOKOL GxP Academy