Senior Process Engineer, Multidiscipline

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:

·       Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
Set-up maintenance for new equipment (incl. spare part needs).

·       Assist with preparation of plans for maintenance / calibration / qualifications.

·       Provides hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems which support the manufacturing facility.

·       Creates, reviews, and approves critical documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.

·       Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.

·       Assist with preparation of estimates for bids and proposals.

·       Perform GMP risk assessments (incl. Sensors SRA).

·       Independently leads and/or provide SME-level support on all phases of projects, from identification to close out.

·       Ensures new equipment is appropriately designed/commissioned/qualified and existing processes run in a compliant manner throughout the equipment lifecycle.

·       Support internal and external audits.

·       Use automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities

·       Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.

·       Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.

·       Supply information and technical data for securing spare parts.

·       Provide responsive customer support with emphasis on customer satisfaction.

·       Perform startup and commissioning & qualification 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

·       Leads small teams to advance facility and equipment changes in line with 5- and 10-year strategic plans.

·       Complete and provide accurate documentation, as required in cGMP operations.

·       Actively monitors equipment performance in compliance with site reliability and maintenance strategies.

·       Collaborates with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.

·       Other related duties as assigned.

·       Use of CMMS system for documentation of relevant work.

The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 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:

·       B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 8+ years’ experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry

·       OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 10+ years’ work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry.

·       Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

·       Excels in a team environment, with excellent communication and organizational skills. Promotes information sharing, facilitates groups to ensure open discussion.

·       Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.

·       Strong project management skill set with ability to manage projects from start-to-end.

·       Applied knowledge of root cause analysis, equipment troubleshooting, automated building management systems, and industrial PLCs

·       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.)

·       Proficient computer skills. Experience using a Computerized Maintenance Management System (CMMS) like Blue Mountain Ram or SAP

·       Ability to climb ladders and lift up to 50 lbs.

·       Aseptic Filling line, packaging operation experience is preferred.

·       Training in radiochemistry or radio pharmacy is preferred.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and 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 tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.