Expert Engineering (Metrology)

Novartis • East Hanover, NJ

1d • Onsite

About The Position

This is a hands-on lead role responsible for the execution of maintenance, calibration and commissioning activities for equipment and instrumentation projects at site level. Performs a wide range of maintenance, calibration, repair, and requalification activities on cell processing/production systems, equipment, and laboratory instrumentation. Ensures efficient, timely GMP, HSE and regulatory compliant maintenance and calibration of systems and equipment to include troubleshooting instrument failures with the ability to diagnose and perform effective repair. Ensures good workmanship with minimum delay to support the safe, effective and compliant operation of the CGT East Hanover laboratory facility equipment.

Requirements

• Execution of equipment and instrument calibrations, preventive maintenance and repairs in pharmaceutical or like regulatory industry.
• Operations management of technicians and maintenance personnel in GxP regulated environment.
• University degree (BSc) or equivalent.
• 5+ years GMP equipment and instrument maintenance and calibration experience in a regulatory pharmaceutical facility, Cell and Gene Production facility & Laboratory systems facility experience preferred.
• English language proficiency.

Nice To Haves

• Cell and Gene Production facility & Laboratory systems facility experience preferred.

Responsibilities

• Leads and performs metrology and maintenance shop-floor activities such as equipment and facility calibration, preventive maintenance, and repairs
• Execute work orders for maintenance & calibration as per method statement/ procedure and completes equipment work orders thoroughly and accurately document them in the Computerized Maintenance Management System.
• Executes and leads maintenance / calibration work on laboratory systems and equipment and performs documented troubleshooting studies on equipment to outline opportunities for improvements.
• Executes Biological safety cabinet and facility HEPA filter certification activities, as well as calibration and testing of production facility systems to include differential pressure controls and facility safety monitoring devices such as O2 & CO2 alarms.
• Support and/or perform investigations / deviations from an engineering / maintenance perspective and help with data for timely closure of deviations and CAPAs.
• Manages tools, spare parts etc. for maintenance I calibration, as required to include the goods receipt, incoming inspection, inventory control, and storage of spare parts to ensure adequate stock for quick repairs and improvements.
• Adhere to all applicable procedures, cGMP, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Plans and schedules third-party vendors for routine and non-routine maintenance and qualification and provides 3rd party service provider oversight as local process Subject Matter Expert (SME).
• Continuously develops personal and professional skills.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree