Engineering Maintenance & CMMS Lead

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced professionals to help us reach our ambitious goals.

Location: Onsite
 

Major Accountabilities:

• Develop maintenance procedures and ensure effective implementation. Schedule and coordinate corrective, preventative maintenance and calibration of all equipment. Ensure all maintenance is performed in a safe, effective, and efficient manner.
• Collaborate with operations to optimize output, uptime, and equipment reliability.
• Provide assistance in oversight and performance management oversight of operating budgets. Monitor department expenses and control budget.
• Review, negotiate, and recommend maintenance and service contracts with appropriate contractors/vendors.
• Interact with internal/external groups to ensure regulatory and compliance systems and processes are implemented. Develop strong working relationships with contractors and service providers
• Responsible for developing a high performing team of Technicians. Oversee and administer all aspects of the major building and engineering systems (e.g. mechanical, electrical, plumbing, specialized piping, pneumatics, HVAC, etc.) in accordance with FDA, OSHA and local and state regulations to ensure appropriate, safe, cost-effective facilities are in place.
• Act as principal assistant/consultant in matters pertaining to building systems/engineering. Participate in Root Cause Investigations as they arise
• Serve as Subject Matter Expert (SME) regarding asset management, reliability, building infrastructure, energy management, and environmental sustainability systems, and manufacturing equipment.
• Oversee and administer all aspects of the major production/manufacturing equipment in accordance with FDA, OSHA, and local and state regulations.
• Responsible for overall project management, coordination, and execution of all facility shutdown activities.
• Support with new equipment startup, validation, and training of personnel
• All other duties as necessary to accomplish the responsibilities.

The pay range for this position at commencement of employment is expected to be between $118, 400 and $177,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Minimum Requirements:

• Bachelor’s degree or 4 additional years of experience in lieu of a degree
• 8+ years of relevant experience is required
• GMP experience is required
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones is preferred
• Practical experience in facility changes and validation as well as successfully managing inspections from major Health Authorities including USA, EMEA, Canada, Japan, Brazil is highly preferred
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity is required