About the Role
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.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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