Jul 21, 2023

Job Description

The Process Engineer II is responsible for support in execution of engineering processes/activities within an aseptic environment (design, implementation, maintenance, etc.) by providing a technical area of expertise while using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives in accordance with the law, internal regulations. 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.
• 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.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Create/Execute DQ, IQ and OQ protocols and reports.
• Perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems.
• Support internal and external audits.
• Provide technical trouble shooting during Startup, PQ and validation activities
• Develop periodic requalification plan
• Execute periodic requalification plan
• Utilize 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.
• Write/revise accurate engineering documents for various production 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
• Complete and provide accurate documentation, as required in cGMP operations.
• 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 $92,800 and $139,200 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.

Diversity & Inclusion / EEO

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.

Minimum Requirements

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 3+ 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 5+ years’ work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry.
• Previous GMP experience.
• Proven skills in project management and problem solving
• 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.
• 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.
• Radiation safety education is preferred.

Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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 [email protected] 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.

Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Indianapolis, IN
Technical Operations
Full Time
careers default image

Process Engineer II

Apply to Job Access Job Account