The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Scientist II, aligned to Advanced Sterilization Products (ASP), located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at www.aspjj.com/us for more information.
The Sr. Process Engineer will:
• Be responsible for providing engineering LCM support to ASP consumable products related but not limited to Biocides, Chemical Indicator Pouches/Rolls, Chemical Indicator/Strips, Detergents, manufactured worldwide.
• Work closely with External manufacture quality and supply chain team to manage ASP consumable products manufactured worldwide.
• Lead or participate in LCM design/manufacturing changes for existing products and/or new product/technology transfer projects through pilot production to commercial production.
• Be responsible for preparation and execution of process / product qualification & validation (IQ, OQ, PQ).
• Use Six Sigma methodology to perform process variability/capability studies, risk analysis, test method validation, OOS root cause analysis and process improvement for the products responsible to manage.
• Lead or participate in CAPA and NCR activities for sustaining products.
• Provide routine technical support to internal or external manufacturing sites responsible to manage.
• A Bachelor’s degree in Chemical Engineering, Chemistry, or related scientific discipline with 6 year experience within the Medical Device, Pharmaceutical, OTC, Packaging and/or chemical industry or a Master’s degree in Chemical Engineering, Chemistry, or related scientific discipline with 4 years experience within the Medical Device, Pharmaceutical, OTC, Packaging and/or chemical industry is required.
• Experience in leading/managing new product development and/or technology transfer projects domestically and/or worldwide is preferred.
• Experience participating in or leading new product transfer from pilot production to commercialization and/or manufacturing process transfer activities preferred.
• Experience in manufacturing process validation and proficient in writing validation protocols (IQ/OQ/PQ) and reports are required.
• Experience in project management and new technology transfer in a multiple cross-functional team environment is preferred.
• Experience in Liquid/Solid formulation manufacturing is preferred. Manufacturing Experience in Medical Devices (HLD/Sterilants), Pharmaceuticals/OTC, Detergents, or liquid/lotion/cream is preferred.
• Experience in packaging and/or molding manufacturing validation is preferred.
• Familiar in identifying critical to quality attributes, analyzing process capabilities and performing FMEA, FTA and hazard/risk analysis is preferred.
• Minimum understanding of general test procedures in manufacturing, e.g. HPLC, GC, FTIR, UV, and general wet chemistry is preferred;
• Proficiency with FDA, EPA , GLP (Good Lab Practices), GMP, ISO 14385 and/or ISO 9000 are preferred.
• Proficient in understanding of regulatory requirements for medical device is preferred.
• Trained under Process Excellence with Black Belt/Green Belt Certificate is preferred.
• Travel up to 20% domestic/international is required.
Ethicon Inc. (6045)
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.