Equipment Qualification Specialist. (contract)

Sanofi

Swiftwater, PA

Estimated pay: Est. $20–$30/hr (market estimate, not employer-stated)

Shift: Contract

Equipment Qualification Specialist.

**Location:** Swiftwater, PA – 100% Onsite

**Schedule:** Monday–Friday, 9:00 AM–5:00 PM ET

**Position Overview**

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Equipment Qualification Specialist. for a 8- month contract. Will support analytical laboratory instrumentation, equipment qualification, calibration, and lifecycle management within a cGMP-regulated pharmaceutical environment.

The ideal candidate will have hands-on experience with analytical instrumentation, equipment qualification (IQ/OQ/PQ), calibration, and GMP compliance. Experience with Controlled Temperature Unit (CTU) temperature mapping or Analytical Instrument Qualification (AIQ) is highly valued.

**Key Responsibilities**

• Support qualification, calibration, preventive maintenance, and troubleshooting of QC laboratory instrumentation, including HPLC, GC, spectroscopy equipment, and other analytical instruments.
• Execute or support equipment and instrument qualification activities, including IQ/OQ/PQ, protocol execution, functional testing, and documentation.
• Perform or support temperature mapping and qualification of Controlled Temperature Units (CTUs), including refrigerators, freezers, incubators, cold rooms, and stability chambers.
• Support temperature mapping studies using Ellab data loggers or comparable systems.
• Review qualification and calibration data to ensure compliance with approved specifications and acceptance criteria.
• Author and maintain GMP documentation, including qualification protocols, validation reports, SOPs, and technical assessments.
• Support equipment-related deviations, CAPAs, change controls, root cause investigations, and corrective actions.
• Collaborate with QC, Quality Assurance, Validation, Engineering, and external vendors to maintain equipment reliability and inspection readiness.

**Required Qualifications**

• Bachelor's degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• Minimum 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, validation, engineering, or QC laboratory environment.
• Hands-on experience supporting equipment or instrument qualification, including IQ/OQ/PQ.
• Experience with CTU temperature mapping/qualification and/or analytical laboratory instrument qualification (AIQ).
• Knowledge of analytical laboratory instrumentation, calibration, preventive maintenance, and GMP documentation.
• Understanding of cGMP requirements, data integrity, and quality systems.
• Experience executing qualification protocols and reviewing results against acceptance criteria.
• Strong troubleshooting, technical writing, and communication skills.

**Preferred Qualifications**

• Experience with HPLC, GC, UV-Vis, spectroscopy, or other analytical laboratory instruments.
• Hands-on CTU temperature mapping using Ellab data loggers or comparable systems.
• Experience with equipment qualification protocols, validation, and instrument lifecycle management.
• Familiarity with deviations, CAPA, change control, and electronic quality management systems (eQMS).
• Experience with laboratory computerized systems such as LIMS or chromatography data systems.