With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.
U.S. Facilities and Operations:
Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.
Under Engineering & Technology direction the Automation & Controls Engineer position will lead the automation, controls, and instrumentation support function for implementing any new automated system as part of the Daytona Beach solutions manufacturing facility, any change to any existing automated system, acting as system administrator for all automated systems, and ensure the integrity of the data generated by automated systems. Provide day to day automation/controls engineering and Project Management support for Daytona Beach, FL facility.
Responsibilities: Essential Duties
Partner with ETM Director of Automation to oversee and coordinate activities regarding the design, construction, factory acceptance testing, installation and commissioning of all automated manufacturing, lab, and facility equipment. Provide technical support for the qualification of the pertinent equipment.
Manage scope, cost and schedule for automation controls projects as required.
Identify, implement and lead data integrity methodologies for automated systems to ensure absolute reliability of the data that’s being generated.
Provide automation/controls engineering support for manufacturing, and act as a liaison between manufacturing and Corporate IT and other business system stakeholders for all manufacturing, QC and facilities controls/automation/data integrity projects.
Implement and manage all automation/controls/data acquisition projects for manufacturing. ensuring that objectives are clearly defined and that project objectives are achieved within budgetary and time constraints.
Ownership of automation system life cycle documents.
Lead Recipe authoring.
Operate automation/controls systems to support project activities and own transition into operational state.
Manage technology and integration vendors to ensure projects meet specifications, and are delivered on time.
Initiate and manage all systems automation/control/data acquisition continuous improvement initiatives.
Responsible for the defense of the automated systems and all executed protocols and reports during regulatory inspections and internal audits.
Expertise: Knowledge & Skills
Ability to meet deadlines
Ability to take initiative and make decisions within department/company guidelines
Ability to demonstrate leadership in job performance
Ability to establish and maintain moderately complex documentation systems,
Ability to accurately perform detail oriented work
Ability to function in a regulated environment and handle confidential information
Ability to use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, etc.).
Extensive knowledge of systems automation, and instrumentation.
Extensive knowledge of Allen Bradley PLC’s.
General knowledge of electrical engineering codes and standards.
Demonstrates a high level knowledge in process controls including detailed understanding of the process, ability to optimize the parameters and optimize the measurable outcomes while minimizing risks of hazards.
Demonstrates proficient knowledge of design documents (i.e. User Requirements, P&IDs, system architecture, drawings, specifications, etc.) and instrumentation/control equipment in an industrial environment.
Demonstrates, optimizes and instructs an expert knowledge of the control methods, analog and discrete and the critical components to developing sustainable control algorithms.
Proficient experience in implementing control methodology in PLC and HMI platforms with a high level of understanding of various programming languages.
Able to easily adapt to a new platform with development support.
Ability to optimize design and implement knowledge of control system architecture including hardware, software, instrumentation and networking equipment.
Proficient understanding of analog advanced control and batch control and ability to lead implementation.
Demonstrates leadership in loop checking, startup, troubleshooting and commissioning support in an industrial environment.
Proficient ability to understand control philosophy and write functional requirement specifications Requirements Knowledge, Skills, and Abilities.
Willingly accepts coaching and mentoring from more experienced resources and provides the same when working with entry level resources.
Promotes teamwork by participating as a team player while also demonstrating effective communication skills with the team and management.
Proactively works to build good relationships with peers, leaders and management while also demonstrating the ability to meet expectations.
Seeks out new responsibilities and stretch opportunities while demonstrating creativity in identifying better means of accomplishing a job.
Displays leadership abilities including honesty, integrity and professionalism across all aspects of the business.
Demonstrates a willing, can-do attitude by actively participating in teams.
Exhibits proficiency and personal accountability for project performance and meeting expectations
Demonstrates a business acumen that allows for effective utilization of tools and standards to ensure project deliverables are met.
Expertise: Qualifications - Experience/Training/Education/Etc
Bachelor of Science Degree in Mechanical or Electrical/Electronic Engineering or other related field required.
5-10 + years of experience designing, programming and testing automation systems in a pharma/biotech manufacturing, laboratory, R&D or pilot plant environment
Automation software experience with Rockwell RSLogix 5000, FactoryTalk® Batch, FactoryTalk® View Site Edition, FactoryTalk® View Machine Edition and PlantPAx is required.
Knowledge of FDA, EU, and global GMP’s including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11
Knowledge of Data Integrity Requirements for FDA, EU, and global regulatory authorities.
Experience with other systems, such as PI-Historian, FactoryTalk Production Centre, and FactoryTalk PharmaSuite
cGMP and Validation experience Life Science / Pharmaceutical industry experience
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.
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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Responsibilities: Other Duties:
Domestic travel with the possibility of International travel.
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.