Process Engineer

Scorpion Therapeutics; United States; Remote; USD 85,000 - 159,000; Full time

Job summary

An innovative firm is seeking a Process Engineer to enhance operations in a GMP environment. This role involves troubleshooting equipment, managing projects, and ensuring compliance with regulatory standards. The ideal candidate will possess a strong engineering background and proven problem-solving skills. Join a team dedicated to delivering cutting-edge radioligand therapy to cancer patients, where your contributions will directly impact patient care. If you're passionate about engineering and looking to make a difference in the pharmaceutical industry, this opportunity is for you!

Qualifications

• 3+ years in automation or engineering in pharma/biotech.
• Experience with aseptic filling lines is preferred.
• Training in radiochemistry or radio safety is desirable.

Responsibilities

• Identify and implement continuous improvement initiatives.
• Ensure compliance with GMP guidelines and industrial standards.
• Lead process equipment and utility improvement projects.

Skills

Project Management

Problem-Solving

Time Management

Organizational Skills

Regulatory Compliance

Education

B.S. in Chemical Engineering

B.S. in Electrical Engineering

B.S. in Mechanical Engineering

B.S. in Nuclear Engineering

Tools

MS Office

Building Management Systems

CMMS

GMP Systems

Job description

Summary

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering targeted radioligand therapy to cancer patients. We seek experienced Manufacturing professionals to help us achieve our goals.

The Process Engineer is responsible for identifying, designing, and implementing continuous improvement initiatives using advanced engineering principles in a GMP environment to ensure high-quality radioligand therapy (RLT) products. They will oversee the reliable and efficient operation of the facility and production equipment, support current projects, and ensure compliance with regulatory, corporate, and site requirements related to Engineering.

About The Role

Major accountabilities:

• Provide technical troubleshooting throughout equipment lifecycle (startup, qualification, commercial production).
• Investigate deviations from an engineering perspective 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, updating as needed.
• Write or revise engineering documents for operation of production systems.
• Ensure compliance with industrial standards and GMP guidelines.
• Develop project cost estimates and review for value improvements.
• Perform GMP risk assessments.
• Manage technical/engineering changes through site change control processes.
• Participate in calibration/maintenance risk assessments for new equipment.
• Create and execute DQ, IQ, OQ, and PQ protocols.
• Support internal and external audits.

The salary range at the start of employment is expected to be between $85,400 and $158,600 per year. Salary adjustments may occur during the year based on market conditions. Final salary depends on factors such as location, experience, and skills. The total compensation may include bonuses, stock units, and other benefits, including medical, financial, and paid time off benefits. Details will be provided upon job offer. Employment is at-will, and the company reserves the right to modify compensation and benefits.

Minimum Requirements

• B.S. in Chemical, Electrical, Mechanical, Nuclear Engineering, or related field, with 3+ years supporting automation, engineering, or similar in pharma or biotech industries.
• Proven project management and problem-solving skills.
• Strong time management, planning, organizational, negotiation, and influencing skills.
• Self-motivated, responsible, and proactive.
• Ability to adhere to procedures, cGMPs, and regulatory standards (OSHA, FDA, EMEA, HS&E, etc.).
• Proficient in MS Office, Building Management Systems, CMMS, and GMP systems.
• Ability to climb ladders and lift up to 50 lbs.
• Experience with aseptic filling lines and packaging is preferred.
• Training or experience in radiochemistry or radio safety is desirable.

Benefits and rewards:

Learn about our offerings at https://www.novartis.com/careers/benefits-rewards.

Why Novartis:

Join us to help change lives through innovation. Collaborate and support each other to achieve breakthroughs. Create a brighter future together: https://www.novartis.com/about/strategy/people-and-culture.

Join our Novartis Network:

Not the right role? Sign up at https://talentnetwork.novartis.com/network to stay connected for future opportunities.

EEO Statement

We are Equal Opportunity Employers. We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, or other protected statuses.

Accessibility & Reasonable Accommodations

We provide accommodations for individuals with disabilities. Contact us at [e-mail] or [phone] with your request and contact info, including the job requisition number.