Process Engineer

We are seeking an experienced Process Engineer to lead the integration and transfer of manufacturing processes into an existing production environment. This role will be responsible for driving projects from early-stage process development through qualification, validation, and implementation within a highly regulated manufacturing setting. The ideal candidate will have experience in medical device and/or pharmaceutical manufacturing , strong validation expertise, and the ability to manage projects while working closely with cross-functional teams. This position requires approximately 50% office-based work and 50% manufacturing floor support . Key Responsibilities Lead the integration and transfer of manufacturing processes into an existing production environment. Develop, qualify, validate, and implement manufacturing processes in accordance with regulatory and quality requirements. Manage project timelines and provide routine progress updates to stakeholders. Perform mechanical and electrical testing, including Gauge Repeatability & Reproducibility (GR&R) studies. Analyze process data using statistical methods, including Process Capability Analysis and Design of Experiments (DOE). Troubleshoot manufacturing processes, equipment, and quality systems while implementing corrective and preventive actions (CAPA). Lead root cause investigations and drive sustainable solutions using structured problem-solving methodologies. Author and maintain change requests, validation protocols, reports, and technical documentation. Collaborate with global manufacturing sites to support process transfer activities and product validation efforts. Ensure compliance with Quality Management System (QMS), GMP, and regulatory requirements. Required Qualifications Bachelor's Degree in Engineering or a related technical discipline with a minimum of 2 years of engineering experience , OR Minimum 7 years of engineering experience in a manufacturing environment in lieu of a degree. 2 to 10 years of experience in Process Engineering, Process Development, Validation, or Manufacturing Engineering. Experience managing projects from concept through validation and implementation. Experience in a highly regulated environment , preferably Medical Device or Pharmaceutical manufacturing. Hands-on knowledge of process validation, equipment qualification, and manufacturing process optimization. Required Skills Strong understanding of: Quality Management Systems (QMS) Process Qualification & Validation Change Control Processes GMP Compliance Proficiency in statistical analysis and problem-solving techniques. Experience with DOE, Process Capability Studies, and GR&R analysis. Strong written and verbal communication skills. Ability to work independently and within cross-functional teams. Excellent analytical, decision-making, and organizational skills. Proficiency with Microsoft Office Suite and statistical analysis tools. Knowledge of manufacturing safety standards and ergonomic practices. Strong project management and coordination capabilities. Preferred Qualifications Experience within Medical Device, Pharmaceutical, Biotechnology, or other regulated manufacturing industries. Prior involvement in manufacturing transfers, process development, or validation projects. Experience supporting international or multi-site manufacturing operations. Training Requirements On-the-job training. Standard Operating Procedures (SOP) training. Good Manufacturing Practices (GMP) training. Physical Requirements Regular computer-based work and documentation activities. Ability to stand, sit, bend, stoop, reach, and move throughout manufacturing areas. Ability to lift and carry items up to 30 lbs occasionally. Work Authorization Candidates must be authorized to work in the United States without current or future sponsorship requirements. #J-18808-Ljbffr Soho Square Solutions