Senior MSAT Engineer

NorthStar Medical Radioisotopes•Beloit, WI

17h•Onsite

About The Position

The Senior MSAT Engineer provides technical support and optimization of production processes, including the technology transfer from external clients or internal stakeholders (such as Process Development to Operations). This role collaborates with cross-functional teams, including Operations, Process Development, Quality Assurance, Maintenance, Supply Chain and Safety to drive continuous improvement, maintain safe, compliant, and efficient production. The position will also be responsible for both internal and external technical transfer activities to support manufacturing readiness. This includes writing and updating of work instructions, batch records and other technical documents pertaining to the development and maintaining of GMP operations and assessment of process data. As well as provide technical input for deviations investigations, change controls, and CAPAs. This role will provide on-the-floor and standby (on-call) technical support to manufacturing as required. All duties and responsibilities will be done in compliance with regulatory agency standards (including cGMP/FDA regulations, OSHA, DOT, and WI DHS).

Requirements

Bachelor’s Degree in a relevant STEM field and minimum six (6) years of relevant progressive experience within a cGMP or other highly regulated environment; or equivalent combination of education and experience.
Knowledge of and experience with the operation of chemical processing or irradiation equipment and manufacturing.

Nice To Haves

Master’s Degree in a relevant STEM field and four (4) years of relevant progressive experience within a cGMP or other highly regulated environment; or equivalent combination of education and experience.
Experience in radiopharmaceutical production.
Experience working with the operation of chemical processing equipment and manufacturing.
Experience working with hot cells and cooling systems.

Responsibilities

Work cross-functionally with other departments to effectively transfer and maintain processes in the facility.
Evaluate existing manufacturing processes and maintenance strategies and identify areas for improvement in efficiency, productivity, process capability, risk, and cost reduction.
Lead or assist in developing/executing design transfer plans for new products and maintain batch production records and process documentation for new and existing programs.
Lead or assist in preparing and executing cGMP and non-cGMP procedures, protocols, reports, and plans for chemical/fluid, filling, hot cells, and packaging processes in radiological and/or clean room environments.
Play active role in developing and driving engineering strategies around processing capabilities, capacity and optimization that align with organizational priorities.
Support the creation and documentation of maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost and risk.
Lead production support for radiological hot cells, irradiation equipment, and chemical/formulation, filling, and packaging processes, including troubleshooting and maintaining, or updating/upgrading fixtures, equipment and systems.
Support assigned maintenance delivery tasks as per system maintenance strategies and procedures.
Support the investigation of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
Prepare and present risk assessments and status updates to upper management.
Assist in developing training programs and provide training on process systems and equipment.