B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
We are seeking a Manufacturing Execution Systems (MES) Engineer to support the implementation, from end to end, of our new MES system at the Daytona Beach solutions manufacturing facility, which is an FDA regulated facility. The MES engineer preferably has experience in one or more of the following areas:
IV solutions manufacturing;
Fill finish process, filling lines, and packaging;
Clean utility systems;
Plant-wide scale automation and information systems;
The MES Engineer will Define functional requirements for MES solutions through documentation analysis and by partnering with cross-functional teams (i.e. Quality, Production, Labs...Etc...), and will be able to address business problems that software solves in the MES layer of the automation pyramid (OEE, ERP integration, Quality, LIMS... etc.)
The MES Engineer will lead/participate in recipe authoring, integration to automation, testing as well as development of the associated documentation (i.e. FS, DS…etc.).
Responsibilities: Essential Duties
• Applies standard engineering techniques to design, analyze, test, maintain, repair or improve products, components or assemblies.
• Analyzes, develops and evaluates systems. Improves and maintains current systems or creates brand new projects.
• Designs and drafts blueprints with designer, visits systems in the field and manages projects.
• Must be SME in field at higher levels of job.
• Applies engineering techniques and analyses within the scope of the assignment.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Expertise: Knowledge & Skills
Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues
Judgement is required in resolving complex problems based on experience.
Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
Preferred Technical Skills and Abilities
Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Rockwell ProPack Data, Werum PAS-X, POMS) is a must.
Knowledge of SAP Material Master (MM), Production Planning (PP), Production Planning for the Process Industry (PP/PI) and Quality Management (QM) modules is highly preferred.
Experience with FactoryTalk Production Centre, PharmaSuite, LabWare LIMS, and PI-Historian is highly desirable. Automation Software experience with RSLogix 5000, FactoryTalk® Batch PlantPAx are helpful. Also, Experience with .NET technologies preferred
Knowledge of FDA, EU, and global GMP's including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11. Relevant Quality education or training within ISO 9001 and cGMP is highly preferred.
Validation experience in the Life Science / Pharmaceutical industry required. Ensure that the system remains in a validated state and that proper change control practices are followed (CCRs, documents updates….etc.). The MES Engineer will also act as the primary contact for Regulatory Compliance internal and external audits.
Experience integrating ANSI/ISA-88 and ANSI/ISA-95 standards where the MES is integrated into the Batch Execution System (BES)
Scope, cost and schedule management skills for automation controls projects is required. Ability to utilize project management standard methods and techniques
Experience managing and assisting in the coordination of outside resources and vendors as well communicating with upper management is highly preferred.
Ability to use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, SAP 3rd Party applications, SQLetc.).
Ability to take initiative and make decisions demonstrating leadership in job performance, while promoting teamwork by participating as a team player that is able to effectively communicate with the team and management.
Occasional business travel required, Valid driver's license and passport, Ability to work non-standard schedule as needed, On-call hours as needed
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.