Operations Engineer

Summary of Position

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve:
An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The Operations Engineer will work in a dynamic organization in the Operations team for North America. This role has the responsibility for supporting the on-time execution and delivery of sterile drug products. This role will report to the Director of Operations.

The Operations Engineer is the primary Operations contact to ensure reliability and quality compliance for manufactured products. This drives reliability improvements and takes a lead role investigating or reviewing deviations / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence.

Work Schedule: 8am - 4:30pm Monday - Friday

• Maintain and manage to closure a list of reliability related improvement efforts for operations and engineering.
• Manages projects or initiatives specifically related to reliability improvements.
• Author and review Change Control / Quality Documents involving product or process changes.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Review validations (equipment, cleaning and/or process) for assigned area.
• Prepares and participates in regulatory agency (i.e. FDA, HC, TGA, etc.) audits as well as internal audits.
• QA contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis).
• Investigate customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required time frames and documented in the sites EQMS (Electronic Quality Management System).
• Assemble, analyze and report batch data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Develop, review and/or revise SOP (Standard Operating Procedures),  ’s (Batch Records), OJT/OJQs, FMEA’s with appropriate change management.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to quickly investigate and close deviation records ahead of product release.
• Ability to communicate with and positively influence broad and diverse cross‑functional teams within and outside the organization.

• Bachelor’s degree in Life Sciences or Engineering required.
• 2 or more years of relevant experience required. Pharmaceutical experience preferred.
• Significant experience investigating deviations and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, Tap Root, Kepner-Tregoe, Comparative Analysis).
• Must be thoroughly familiar with applicable US and international regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment is strongly preferred.
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must have experience with statistical tools Certification in Lean or Six Sigma preferred.
• Strong project…