Process Engineer 1

Process Engineer 1 SHL Medical Assembly&Servc LLC Deerfield Beach, FL Job Details 1 day ago Benefits Career development plan Qualifications Laboratory procedures Spreadsheets Word embeddings Good documentation practices (GDP) Biomedical regulatory compliance Risk assessment Productivity software Design of mechanical systems Cross-functional communication FDA regulations Customer complaint resolution Full Job Description SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States. Job Overview Process Engineers are responsible for supporting the implementation of new process systems into manufacturing production while ensuring that all activities are completed and documented by SHL Pharma Quality System requirements. Serving as the voice of operations between the development site and manufacturing site, the Process Engineer will be responsible for supporting the design, development, testing, and evaluation of assembly, labeling, packaging, and serialization operations. Execute Manufacturing Sciences (MS) Project activities under the guidance of MS Senior Process Engineers/MS Principal Process Engineers and MS Manager. Main Responsibilities Support design transfer, specifically the final assembly, labeling, packaging, and serialization of products as they hand-off from development to commercial launch. Support the design, qualification, and implementation of new production equipment. Draft and update Engineering Protocols (ENP) and Reports (ENR), Batch Records (BR), Bill of Materials (BOM), Technical Specifications (TS), Product Specifications (PS), Quality Work Instructions (QWI), Quality Operating Procedures (QOP), Quality Forms (QF), Templates (TEM), equipment design and qualification documentation (e.g., URS), pFMEAs, Change Controls, etc. Draft documentation for computerized system validation (CSV) including Functional/Design Specifications, Design Qualification (DQ), Functional Risk Assessment (FRA), Requirements Traceability Matrix (RTM), etc. Draft and execute Validation Project Plans (VPP), Validation Final Reports (VFR), and periodic reviews, as well as protocols and reports for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, Installation Operational Qualification (IOQ), Performance Qualification (PQ), and Process Validation (PV). Document MS activities to support the MS Key Performance Indicators (KPI) tracking. Perform troubleshooting and root cause analysis with a cross-functional team to conduct investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc. Serve as the second line of support after Manufacturing Engineering (ME) to Manufacturing (MFG). Provide training on production equipment to ME and MFG personnel. Identify opportunities for continuous improvement in MS and support the execution and implementation of LEAN projects. Support and conduct customer complaint investigations. Support or lead machine shop activities. Comply with all quality, safety, and industry regulations. Skills and Qualification B.S. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred. 0-2 years of experience within the medical device industry is preferred. Familiarity with industry practices and guidelines including those outlined by the FDA and ISO is required. Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required. Must have practical experience and a solid understanding of mechanical design principles, testing, and manufacturing processes. Proficiency in Microsoft Excel and Microsoft Word is required. Effective communication (written and verbal) and collaboration within cross-functional teams are required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle or feel objects, tools, or controls; reach with hands and arms; stoop, kneel, or crouch. Specific vision abilities required by this job include close vision, and the ability to adjust focus. We Offer Competitive compensation package Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast-growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization