Site Maintenance Lead

Band

Level 4

Job Description Summary

The Site Maintenance Lead is responsible for oversight and leadership of all maintenance and calibration activities support for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. They will lead a team of site-based technicians to establish maintain and improve site maintenance and calibration programs and activities. Responsible for reliable efficient and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory corporate and site requirements related to their functional area.

Location: Onsite

Job Description

Major accountabilities:

Lead development and implementation of site maintenance/calibration program

Ensures equipment operates to required HSE Quality Environmental and Reliability standards

Lead or contribute to equipment utility facility improvement projects (e.g. energy efficiency productivity environmental compliance

Support internal and external audits

Manage maintenance improvement projects and initiatives (local or corporate)

Establish maintenance & calibration plan content

Enter master data into CMMS (e.g. confirmation and technician time allocations)

Establish vendor contracts project engineering & control and identify technical solutions

Coordinate maintenance / calibration activities and Plan resources for maintenance / calibration

Perform a wide range of maintenance repair activities on production equipment central utilities systems lab equipment and building management systems.

Assist in troubleshooting and repair of utility systems which may include HVAC Cold/Warm Rooms control systems compressed gases plant steam/condensate filling line under little to no supervision.

Interpret P&IDs equipment/system layouts wiring diagrams and specifications in planning and performing maintenance and repairs.

Write/revise training documents and maintenance procedures for various production and utility systems.

Provide radiation safety program support responsible for calibration and functionality of all radiation detection equipment

Completes Equipment Work Order Thoroughly and Accurately and Documents them in the System

Supply information and technical data for securing spare parts.

Provide responsive customer support with emphasis on customer satisfaction.

Perform startup and commissioning activities as required.

Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs

Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment.

Complete and provide accurate documentation as required in cGMP operations.

Oversee work and provide training of less experienced maintenance technicians and/or new technicians.

Other related duties as assigned.

Use of CMMS system for documentation of relevant work.

The salary for this position is expected to range between $114100 and $211900 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.

Minimum Requirements:

Bachelor of Science Degree in engineering or related field or equivalent experience and 7 years relevant experience (GMP biotech/biopharma industry preferred)

Self-motivated with a strong sense of ownership in areas of responsibility.

Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.

Demonstrated ability to work and collaborate on cross functional teams (QE QA validation operations) in a fast paced dynamic team setting.

Strong interpersonal and excellent verbal and written communication skills are essential.

Planning problem analysis and decision-making skills.

Proficient computer skill utilizing MS Office suite applications Building Management Systems and Computerized Maintenance Management Systems (CMMS).

Must be able to adhere to all applicable procedures cGMPs company policies and any other quality or regulatory requirements. (For example: OSHA DEA FDA EMEA ANVISA HS&E etc.)

Experience in operating and maintaining mechanical systems in a cGMP or other regulated environment.

Ability to climb ladders and lift up to 50 lbs.

Must be flexible to work nights weekends and holidays as required.

Desirable requirements:

1 years of previous supervisory experience.

5 years experience in pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy (preferred)

Training in radiochemistry or radio pharmacy is an advantage (preferred)

Radiation safety education (preferred)

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$114100.00 - $211900.00

Skills Desired

Api (Application Programming Interface) Api (Application Programming Interface) Automation Technology Back-End Development Business Continuity Change Controls Chemistry Design Development Electronic Components General Hse Knowledge Including Gdp Java Knowledge Of Capa Knowledge Of Gmp Kubernetes Managing Performance Improvement Manufacturing Production Mathematical Optimization Project Commissioning Project Engineering Project Implementations Risk Management Root Cause Analysis (RCA) Scrum (Programming Methodology) 2 more