Reporting to the Supervisor of Manufacturing Engineering, this position is responsible for support of manufacturing operations and process scale–up, process and equipment improvement activities. Oversee projects to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, and error proof manufacturing processes. Maintain and upgrade process equipment, plan, develop, and validate equipment and processes to meet the demands of new product introductions and current manufacturing operations.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Responsible for process engineering and project management to support process scale-up and current manufacturing operations. These projects are typically of increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.
Responsible for projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting. Must be able to perform/deliver specific project tasks as necessary.
Oversee projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
Initiate, develop and implement IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations.
Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings.
Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).
Provide daily analytical and technical support to meet manufacturing objectives.
Responsible for providing plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.
Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing. Evaluate and upgrade process equipment as required.
Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements (US FDA and ISO).
Provide technical input for analysis of process and equipment changes.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
BS (MS preferred) in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, or equivalent.
Type and Number Years of Experience
Minimum of 1-5 years’ experience in the medical device or pharmaceutical industry with experience in process development and/or process engineering.
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required. Experience with biomaterials, in cleanrooms, and Lyophilization a plus.
Experience with Statistical Process Control tools required (SPC, Minitab, other software).
General chemistry, processing and material expertise.
Considerable knowledge of the principles and practices of engineering as applied to various types of projects.
Ability to prepare complex technical reports, project summaries, and correspondence.
Exceptional practical problem solving skills, excellent organizational and communication skills.
Six Sigma. LEAN a plus.