B. Braun

Sr. Engineering Specialist - Automation

Job Locations US-CA-Irvine
Requisition ID
2020-16987
Company
B. Braun Medical Inc
# of Openings
1
Category
Engineering
Position Type
Regular Full-Time
Shift
Days Mon - Fri 8:00 - 5:00pm
Site
Irvine, CA

Overview

About B. Braun 

 

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.

Responsibilities

Position Summary:

 

Provide engineering and automation support to the day to day operations and improvements for operation and facility equipment and control systems in a GMP regulated environment. Participate in a rotating after-hour on-call program. Automated Control Systems to be supported includes Allen Bradley and Siemens PLCs, RA PharmaSuite, RA Plant-PAX, Wonderware In-Touch/In-Batch, Ignition HMIs and Historians. Systems to be supported include MES, LIMS, EBR, WFI system, Track and Trace system, Steam and Building automation. Automated Equipment to be supported includes Sterilizer tanks and equipment, Weigh and Mix equipment, bulk loading and solid and liquid dispensing equipment, Conveyor system with VFDs and Servo Drives among others. Provide engineering expertise for the design, development, evaluation, implementation, startup, verification, maintenance, sustainability, and optimization of control systems in solution manufacturing and delivery processes.

 

Responsibilities: Essential Duties

  • Analyzes existing equipment, processes, facilities, infrastructure and systems to identify areas of improvement and recommend solutions to optimize performance.
  • Acts as a Subject Matter Expert for designated systems/ technologies and provide technical recommendations.
  • Anticipates potential process related problems, risks and technical conflicts and develop necessary contingency plans to improve business continuity.
  • Performs troubleshooting and modifications to the automated equipment adhering to Pharmaceutical and Medical Devices GMP change control standards and policies.
  • Creates and modifies system specifications and standard operating procedures for the systems supported.
  • Trains users and peers on systems.
  • Supports software life cycle efforts.
  • Contributes to development of continuous improvement to systems.
  • Supports documentation, testing, commissioning and validation activities following GDP.
  • Provides project implementation support.
  • Performs administrative, upgrades and maintenance tasks for equipment/control systems.
  • Implements and manages automation/controls/data acquisition projects for manufacturing ensuring that objectives are clearly defined and that project objectives are achieved within budgetary and time constraints.
  • Supervises consultants and contractors.
  • Manages technology and integration vendors to ensure projects meet specifications, and are delivered on time and within budget.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

 

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
 
General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

 

Expertise: Knowledge & Skills

  • Extensive knowledge of systems automation, and instrumentation, system requirements and functions.
  • Knowledgeable in Data Integrity Requirements for FDA, EU, and global regulatory authorities.
  • Extensive experience in complex control systems including motion control systems, vision systems, delivering and conveying systems, CIP.
  • Experience in batch production operation and control systems.
  • Proficient knowledge of design documents (i.e. User Requirements, P&IDs, system architecture, drawings, specifications, etc.) and instrumentation/control equipment in an industrial environment.
  • Knowledgeable in Industry 4.0.
  • Extensive knowledge of MES and PCS.
  • Automation software experience with Rockwell RSLogix 5000, FactoryTalk® Batch, FactoryTalk® View Site Edition, FactoryTalk® View Machine Edition and PlantPAX as well as other systems, such as PI-Historian, FactoryTalk  Production Centre, and FactoryTalk PharmaSuite.
  • Proficient experience in implementing control methodology in PLC and HMI platforms with a high level of understanding of various programming languages.
  • 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.
  • 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.
  • Proficient ability to understand control philosophy and write functional requirement specifications.
  • Works under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Ability to build good relationships with peers, leaders, and management while also demonstrating the ability to meet expectations
  • Judgement is required in resolving complex problems based on experience.
  • Proficiency and personal accountability for project performance and meeting expectations.
  • Knowledge of FDA, EU, and global GMP’s including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11.
  • Ability to manage scope, cost and schedule for medium complex automation and controls projects without assistance.
  • cGMP and Validation experience Life Science / Pharmaceutical industry experience preferred.
  • Bachelors degree in Automation, Electrical, Controls or Mechanical Engineering preferred.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required.
  • 10-12 years related experience required.
  • Regular and predictable attendance
  • Occasional business travel required, Valid driver's license and passport

 

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.

 

Other

Responsibilities: Other Duties:

 

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.

 

Physical Demands:

While performing the duties of this job, the employee is expected to:

  • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

  • Occasionally:Reaching upward and downward, Push/pull
  • Frequently:Stand, Sit
  • Constantly:N/A

Activities:

  • Occasionally:Handling, Push/pull, Reaching upward and downward
  • Frequently:Sitting , Standing, Talking - ordinary, loud/quick, Walking
  • Constantly:N/A

Environmental Conditions:

  • Occasionally:N/A
  • Frequently:Proximity to moving parts
  • Constantly:N/A

Work Environment:

 

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.

  • Noise Intensity:Moderate
  • Occasionally:N/A
  • Frequently:Office environment, Production/manufacturing environment
  • Constantly:N/A

 

Notices

Equal Opportunity Employer Veterans/Disabled

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