Staff Engineer, Process Development [Devices] - (Job Number: 0810129)

Staff Engineer, Process Development [Devices] - (Job Number: 0810129) Description Centocor, Inc., a member of Johnson && Johnson's Family of Companies, is recruiting for a Staff Engineer Process Development, located in Horsham, Pa. Centocor, Inc., is a fully integrated biopharmaceutical and biotechnology company. As a world leader in the field of biomedicines, Centocor strives to seek innovative ways to treat cancer and immune-mediated immunology disorders. At the forefront of monoclonal antibody technology and manufacturing, Centocor, Inc. manufactures products including REMICADE® (infliximab) for the treatment of rheumatoid arthritis, Crohn's disease, ankylosing spondylitis and psoriatic arthritis, and ReoPro® (abciximab) for use in percutaneous coronary intervention. Next-generation products are on the horizon and look to continue the company's success in improving the lives of patients around the world. A Staff Engineer, Process Development [Devices] at Centocor is responsible for identifying, planning, designing, developing, qualifying, and validating manufacturing processes related to medical devices. The Staff Engineer, Process Development will have experience in a number of medical device manufacturing process technologies including molding, extrusion, bonding/welding [plastics], post-processing, finishing, assembly, etc. The position will oversee the specification, development, and acceptance of associated manufacturing equipment fabricated at vendors. The Staff Engineer will help develop outside vendors capable of manufacturing product to Centocor standards. In addition, this position will need to work with the design development engineers to assure each design is capable of high-quality, high-yield, low-cost manufacturing. A working knowledge of design transfer activities as it relates to devices is required. At the Staff Engineer level, this position will be expected to work independently across the entire scope of manufacturing activities associated with the introduction of new medical devices. This position will need to work closely with internal and external groups to develop robust plans to meet project objectives. Assessing and making recommendations regarding product design changes needed to support robust product manufacture. Assessing and making recommendations that will establish specifications for manufacturing equipment and processes, that will help vendors troubleshoot issues related to manufacturing processes, and that will assure robust qualification and validation of manufacturing equipment/processes, including the associated inspection processes. Works on most assignments with instructions about the general results expected. May receive technical guidance on the most unusual or complex problems, but independently determines and develops approaches to solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Erroneous decisions or recommendations or failure to get results would normally result in serious program/project delay and considerable expenditure or resources. The candidate has technical responsibility for interpreting, organizing, executing, and coordinating assignments. In addition the candidate will plan and develop engineering projects, which have an effect on assigned organizational programs. This involves exploration of subject area, definition of scope and selection of problems for investigation and development of novel concepts and approaches. Supervision received is administrative in nature and assignments are given in terms of objectives and limits. The candidate will evaluate progress and results obtained, and recommends major changes to achieve overall objectives. The candidate may coordinate the work of other internal resources and may oversee the work of outside vendors on particular projects.Candidates will be responsible for design and recommendation of equipment that meets health, safety and environmental standards set by the company. Candidates will also be responsible for performing design reviews and re-validation assessments to ensure the safe and environmentally sound start-up of new processes. In addition candidates will be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. This position requires a minimum of a BS degree in relevant discipline (Mechanical Eng. Preferred) and 7 years of related engineering experience, or a MS with 5 years of engineering. Candidates who possess a PE license are desirable. Experience working with medical device or pharmaceutical industry is required. It is desired that candidates understand current medical device regulatory requirements, including Quality System Regulation and Device Design Control. It is also desired that candidates understand device process design, development, verification and validation requirements. Candidates are requires an understanding of component manufacturing processes and tooling methodologies. In addition candidates are requires to possess knowledge of general engineering principles, materials, design for manufacturability, and reliability to achieve product design requirements. It is desired that candidates apply risk management methodologies and Failure Mode Effects Analysis (FMEA). Candidates are required to demonstrate working knowledge of equipment and manufacturing line process validation requirements. It is required for candidates to demonstrate communication skills on both technical and business issues with all levels of management, internal customers, and external vendors, as well as demonstrating problem-solving, analytical skills, and project management. This position is located in Horsham, Pa. This position will require 25% international and domestic travel. Centocor is committed to working with any applicant or employee to make reasonable accommodations in job structure in consideration of any known physical challenges or disabilities. If you want to explore the many small-company environments behind the big-company Apply Now