What are the responsibilities and job description for the Senior Validation Engineer position at NorthStar Medical Radioisotopes?
Position
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. Establish Commissioning and Qualification (C&Q) policies/strategies, lead specific C&Q projects for radioactive pharmaceutical manufacturing equipment and processes and ensuring compliance with quality standards/requirements and industry standards (FDA, EMA, ISO, ICH, etc.). Drive C&Q project completion and compliance in a challenging and fast-moving environment in a timely and efficient manner. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. Effectively communicate safety and quality issues raised by customers or staff in a timely manner. Assist in the change management of facilities, utilities, systems, equipment (FUSE) and processes. Develop and manage the C&Q Programs/Processes including generating and maintaining site and project C&Q plans, overseeing C&Q schedules/activities, and coordinating various C&Q activities with cross functional teams. Develop and maintain C&Q Training Module. Work with cross-functional teams in design reviews, impact assessments, generation of requirements, risk assessments and other identified C&Q deliverables. Manage, lead, and generate protocols/reports and execute commissioning and qualification activities for the following: a. GMP Manufacturing Facilities b. Temperature controlled environments (Warehouse, Incubators, Freezers, Refrigerators, etc.) c. Hot Cells, dissolution tanks, radioactive dispensing systems and liquid distribution systems d. Utilities (WFI, Purified (USP), DI, Clean Steam, Natural Gases, Compressed Air, etc.) e. Laboratory equipment (HPLC, TOC, Laminar Flow Hoods, BSC, etc.) f. Sterilization equipment including but not limited to Autoclaves g. Cleaning equipment (Clean in Place (CIP) h. Computer Systems including but not limited to Electronic Document Management Systems (EDMS). Manage and provide guidance and technical expertise in cycle development initiatives and activities, as well as cleaning and process development/commercial activities. Participate in audits and follow up on corrective actions. Contribute to the training and mentorship of level I & II engineers and various contractors on C&Q principles and activities. Contribute to the development of departmental budget and monitoring of expenditures. Exhibit behaviors and core values that supports Quality System and Health & Safety Program by following policies and procedures.
Position requires domestic travel for 15% of time.
Position allows for partial remote work. Must live within reasonable commuting distance. Reports to company office in Beloit, WI.
Qualifications
Bachelor’s degree in Engineering (including Mechanical, Biotechnology, Pharmaceuticals, Biomedical), or a related field and 4 years of related experience, which must include some experience in each of the following skills: Minitab for statistical analysis and data visualization to map drifts in process data; Applying Lean and Six Sigma methodologies to validation and process engineering, ensuring efficiency, quality, and compliance within the validation process; Quality Management System principles and industry best practices pertaining to FDA, ISO, EU, ICH, and ASTM standards; Validating test methods, including designing, and executing validation protocols, analyzing validation data, and ensuring compliance with FDA, ISO, or other relevant standard regulatory requirements; Current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment; Equipment validations including installation qualification, operational qualification, and performance qualifications.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
