Global Technical Operations Engineer Job Job in Wilson, North Carolina US

Global Technical Operations Engineer Job

Global Technical Operations Engineer-PAC000115 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Responsible for providing technical support for Packaging Operations at MSD-Wilson. Determining best methods for providing optimum performance in manning, equipment, systems, documentation, and asset utilization. Daily activities include implementing packaging equipment changes, optimizations, and improvements; executing associated change requests and qualification documentation; investigating and identifying root causes for atypical events in packaging and implementing robust solutions utilizing Lean Six Sigma methodologies; managing projects related to new product introductions, product transfers and equipment/technology improvements. Provide leadership/coaching for contractors and junior Engineers. Responsible for identifying and applying creative technical solutions aimed at cost reduction, efficiency improvments, waste reduction and quality enhancements of products to meet all regulatory requirements. Lead or provide engineering support for the effective packaging transfer of new products/technologies; all aspects of packaging process change control (evaluation, approval, communication, planning scheduling, validation and project documentation, auditing, training, implementation); all aspects of project management (analysis, design, planning, scheduling, securing funds, coordinating equipment procurement, cost control, supervising, contracted resources, status reporting, communication, ensuring team involvement); benchmarking other industries to achieve world class performance; designing/conducting scientific experiments to support process change proposals and package development for new and in-line products; develop capital estimates and manage approved capital funds. Consults with Operational Coaches to support real time processing decisions and with all Merck operations and staff areas in determining technical and strategic directions and initiatives for the plant. Writes and executes qualification/validation documents using the System Life Cycle Methodology approach to support and comply with Merck Corporate and FDA requirements. Leading or provide engineering support to identify root causes of packaging atypical events and implement robust preventive and corrective actions utilizing Lean Six Sigma methods. Qualifications Required Skills: * 5+ years of FDA regulated packaging industry experience. * 5+ years of experience managing/leading a technical team. * Demonstrated leadership ability. * Experience with high speed automated packaging equipment and equipment control systems (i.e. PLC's), validation, and pharmaceutical blister, bottle, FFS packaging processes. * Experience with and knowledge of Good Manufacturing Practices (GMP), GMP documentation, change control, equipment qualification (i.e. IQ/OQ/PQ) and FDA regulations. * Demonstrated skills in technical writing, reading Engineering drawings (schematics, I/O drawings), application of Lean Six Sigma tools, writing and executing packaging equipment qualification documentation. * Proven ability to evaluate impact of packaging related atypical events to pharmaceutical product stability, efficacy and safety and to provide high quality written technical evaluations related to same. Preferred Skills: * In depth knowledge of Lean Six Sigma methodology, flow, OEE and constraint management. * Expert level knowledge of pharmaceutical packaging materials and packaging related equipment. * Experience with FDA/Regulatory inspections * Experience with Packaging Cleaning Validation regulations and procedures. * Experience with vaccine vial packaging * CBER experience Degree/Experience Requirements: Minimum of B.S. in related Engineering or Science field with 5+ years packaging experience or Graduate degree, or 10+ years of related experience; expert level knowledge of process controls systems (vision systems, PLCs), new product development processes, Pharmaceutical bottle/blister/FFS packaging and other packaging processes. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. merck.com/careers to create a profile and your resume for requisition PAC000115. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location: US-NC-Wilson Employee Status: Regular Number of Openings: 1 *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Merck prefers that you apply to this job directly on their site