Process Engineer

JOB REQUIREMENTS: SHINE Technologies is seeking a Process Engineer whowill play a critical leadership role in the development, scale-up, andoptimization of manufacturing processes for therapeuticradiopharmaceutical products used to help treat life-threatening formsof cancer. The Process Engineer ensures that all processes meet output,quality, cost, and compliance goals in a highly regulated, fast-pacedenvironment. The base salary range for this position is\$92,000-\$130,000 plus a comprehensive compensation package. Our salaryranges are determined by role, level, and location. Duties andResponsibilities of the Process Engineer: Lead the design, development,and validation of manufacturing processes compliant with FDA cGMPregulations. Translate R&D-scale procedures into robust, scalableproduction processes and equipment requirements. Develop process flowdiagrams and critical process parameters. Lead equipment selection,installation, and collaboratively develop qualifications (IQ, OQ, PQ)and start-up activities. Develop, author, and maintain SOPs, batchproduction records, process specifications, and technical documentation.Conduct troubleshooting and implement corrective actions to improvesystem reliability and process robustness. Identify, analyze, andresolve process bottlenecks to optimize productivity and productquality. Implement metrics and monitoring systems to drive continuousprocess improvements. Propose upgrades and modifications to improveoperational efficiency, cost-effectiveness, safety, and reduce waste.Partner with Quality Assurance and Regulatory Affairs to ensuremanufacturing processes meet all compliance and validation requirements.Work closely with Research & Development teams to refine processes andsupport technology transfer activities. Lead or contribute to HAZOP,FMEA, and risk assessments to support safe and compliant operations.\*\*\*\*\* OTHER EXPERIENCE AND QUALIFICATIONS: Bachelor\'s degree inChemical, Mechanical or Nuclear Engineering, Chemistry, Radiochemistry,or Physics. 5+ years of process engineering experience in aGMP-regulated manufacturing environment. Experience with nuclear processequipment, chromatography, and/or vacuum systems. Familiarity with riskassessment tools such as HAZOP, FMEA, and performing design calculations(e.g., mass balance, heat transfer). Six Sigma, Lean Manufacturing, orrelated process improvement certification. Demonstrated experience withprocess validation (IQ, OQ, PQ) and GMP documentation. Ability to readand interpret engineering drawings, P&IDs, technical schematics, followwritten procedures, and accurately record test data. Strong analyticaland problem-solving skills with attention to detail. Willingness andability to work safely in a radiological environment. Some travel may berequired Eligibility for employment is conditioned on the applicant\'sability to qualify for access to information subject to U.S. ExportControls. Additionally, applicant\'s eligibility may be conditionedbased upon meeting the Nuclear Regulatory Commission requirements foraccess to Safeguards Information, which typically requires apre-employment drug screen, fingerprinting and criminal backgroundcheck. SHINE values diversity in all its forms as a critical componentof innovation, which is fundamental to our success. Every member of theSHINE community benefits from the talents and experiences of our peers,from the mutual respect we exercise, and from the responsibility we takefor our actions. SHINE Technologies is an equal opportunity employer.All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex, sexual orientation, genderidentity, national origin, disability or veteran status. PayTransparency Policy Employee Rights Under the NLRA Equal OpportunityEmployment E-Verify \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:https://rec uiting.paylocity.com/recruiting/jobs/Apply/3233416/SHINE-Technologies-LLC/Process-Engineer