Process Engineer

  • Indianapolis, IN
  • Posted 5 days ago | Updated 6 hours ago

Overview

On Site
USD 63,600.00 - 118,200.00 per year
Full Time

Skills

Innovation
Continuous Improvement
Startups
IDS
Electrical Wiring
Regulatory Compliance
Project Costing
Estimating
Change Control
Risk Assessment
PQ
Auditing
Electrical Engineering
Mechanical Engineering
Pharmaceutics
Biotechnology
Project Management
Conflict Resolution
Problem Solving
Negotiations
EMEA
Computer Literacy
Microsoft Office
Management
Maintenance Management
CMMS
Radio
Recruiting
Training
Promotions
Accessibility
Computer Networking
Collaboration
EHS
HSE
Heat Transfer
HVAC
Adobe AIR
GDP
GMP
Manufacturing
Optimization
Microsoft Word
Outside Sales
Physics
Software Troubleshooting
Teamwork
Test Equipment
Total Productive Maintenance

Job Details

Job Description Summary
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 Manufacturing professionals to help us reach our ambitious goals.

The Process Engineer is responsible for identifying, designing and implementing continuous improvement initiatives using advanced engineering principles in a GMP environment to ensure the delivery of high-quality radioligand therapy (RLT) products. Responsible for reliable, efficient and sustained operation of the facility and all production equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to Engineering.

Job Description

Major accountabilities:

  • Provide technical troubleshooting throughout equipment lifecycle (startup, qualification, commercial production)
  • Perform investigations / deviations from an engineering perspective to allow for timely closure of deviations and CAPAs
  • Lead or contribute to process equipment and utility improvement projects
  • Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed
  • Write/revise engineering documents for operation of various production systems
  • Ensure compliance with industrial standards and GMP guidelines
  • Develop project cost estimation and value improvement review
  • Perform GMP risk assessments
  • Manage technical / engineering changes through site change control process
  • Participate in preparation of calibration/maintenance risk assessments for new equipment
  • Create/execute Design Qualification (DQ), Installation and Operational Qualification (IOQ), and Performance Qualification (PQ) protocols
  • Support internal and external audits

The salary for this position is expected to range between $63,600 and $118,200 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.

Minimum Requirements:

  • B.S. degree in Chemical, Electrical, Mechanical or Nuclear Engineering, or related technical field, with a 1+ years experience providing automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
  • Proven skills in project management and problem solving
  • Exceptional time management, planning, organizational, negotiating and influencing skills
  • Highly self-motivated with a willingness to assume responsibilities and take ownership for work
  • Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, FDA, EMEA, HS&E, etc.)
  • Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) and similar GMP systems
  • Ability to climb ladders and lift up to up to 50 lbs.
  • Aseptic Filling line, packaging operation experience is preferred
  • Training/experience in radiochemistry or radio safety is desirable

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$63,600.00 - $118,200.00

Skills Desired
Architectural Engineering, Business Networking, Cooperation, Efficiency, Employee Welfare, General Hse Knowledge , Heat Transfer, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Job Description, Knowledge Of Gmp, Manufacturing Production, Mathematical Optimization, Microsoft Word, Outside Sales, Physics, Qualification, Software Troubleshooting, Team Work, Test Equipment, Total Productive Maintenance
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.