Job Description Summary
Location: East Hanover, United States

Novartis will not sponsor visas for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

This role is required to be in our East Hanover, NJ office 5x/week

Role Purpose:
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.

Job Description

Major accountabilities:

• 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.

Key performance indicators:

• Highest safety standard implemented during projects and operations
• No critical findings in HSE or regulatory/internal audits
• Completes PM's and Calibrations on time as scheduled
• GMP/HSE compliance
• Adherence to Site KPls

Minimum 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.

Education: University degree (BSc) or equivalent.

Experience: 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.

Language: English

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $93,800 and $174,200 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days,

holidays and other leaves.

Salary Range
$93,800.00 - $174,200.00

Skills Desired