Ethicon, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Sterilization Site Lead to be located in San Lorenzo, PR.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Sterilization Site Lead, you will:
• Be responsible for the Dry Heat, EO and Gamma sterilization execution maintenance activities, and the first point of contact for technical inquiries from Ethicon Manufacturing and External Manufactures.
• Plan, conduct, and direct engineering projects or studies including complete projects requiring advanced knowledge of sterilization.
• Oversee the daily sterilization operations; including review of deviations and corrections, and trend assessments. Provide technical support to sterilization process.
• Execute periodic qualifications and performance metrics for sterilization process. Conduct validation of new processes and products (PQ); establishment of criteria for success.
• Assess impact of product/process change control for sterilization. Establish qualification criteria for external sterilization contractors and micro labs.
• Conduct EO and Dry heat cycle re-qualifications.
• Perform periodic product EO residual analysis.
• Monitor bio burden program.
• Work on project teams providing sterilization expertise to help build internal knowledge and aid in business decision-making.
• Provide technical support for any non-conformance, product disposition and CAPA.
• Perform other duties, as required by Supervisor.
• A minimum of a Bachelor’s degree in Science, Engineering, Bio Medical or related field is required.
• A minimum of 6 years of overall experience within the manufacturing regulated industry is required. Must have experience within the medical device industry.
• Broad understanding of environmental control, packaging, and manufacturing process impact on sterility assurance is required.
• Thorough experience in sterilization processes; Ethylene Oxide, radiation and/or dry heat process knowledge is required.
• Proven experience in change control process within a regulated industry, including development, implementation and test method validation is highly preferred.
• Knowledgeable in ISO, FDA and other regulated standards is required.
• Must be current on government regulations and international regulations regarding the sterilization of medical devices.
• Bilingual (Spanish & English), written and oral.
• Advanced computer skills (Microsoft Office) and use of software application(s) are required. Experience with LIMS or JDE is preferred.
• Working knowledge of CAPA and non-conformance systems is required.
• Proficient in the preparation of technical reports and presentations.
• Strong communication and interpersonal skills. Prudent risk taken.
• Proficient with leadership in project management and technical expertise.
• Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• The position requires up to 10% of travel time.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Puerto Rico-San Lorenzo-
Ethicon Endo Surgery, LLC (7597)