Position Summary

JOB DESCRIPTION

Provide subject matter expertise for energized fabrication systems at the manufacturing site. Interact with management and site customer groups to establish and define requirements for and implementation of technical solutions to fabrication of pharmaceutical plastic flexible containers utilizing energized systems, including radio frequency power. Develop conceptual designs, provide inputs to budgets and develop execution schedules for installations. Leverage external academic and industry expertise to identify and develop state of the art medical and pharmaceutical container fabrication equipment which complies with all relevant global pharmaceutical and medical device regulatory requirements.

Essential Duties & Responsibilities

• Provide or coordinate through internal and external resources the development of complete design documentation for energized fabrication projects. Select, manage and coordinate the efforts of design consultants and firms as appropriate.
• Develop strategy and documents required to secure competitive bids for design services, construction services, major equipment and other goods/services as appropriate.
• Manage and coordinate (with site customers, employees, engineering project managers and other personnel) the efforts for successful (i.e. safe, timely, high quality, cost effective, cGMP, legal) implementation of relevant projects.
• Work with site Technical, Quality, Engineering and Operations leadership to establish long term technical pharmaceutical/medical plastic container fabrication strategy.
• Communicate effectively across disciplines and with internal and external stakeholders on technical fabrication strategic information, tactical updates (e.g. project execution details), and issue resolution
• Effectively lead Project Teams from concept through validation and communicate effectively to all stakeholders.
• Ensure that all applicable local, state and federal regulatory requirements are met on energized fabrication equipment projects. SME on energized fabrication technology and application with internal and external regulatory representatives
• Assist maintenance and plant engineering in the troubleshooting of energized fabrication equipment in the manufacturing areas
• Build site expertise in energized pharmaceutical/medical container fabrication systems through development of technical documentation, instruction, and technical training
  
  

Knowledge, Skills & Qualifications

• Strong interpersonal skills and demonstrated record of teamwork, adaptability, innovation and initiative.
• Strong oral and written communication skills.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.
• Available to work flexible schedule as workload demands.
  
  

Education And Experience

• Bachelor’s Degree is required in Electrical Engineering, Mechanical Engineering or equivalent with extensive expertise in radio frequency circuits and equipment.
• 4 or more years’ experience in troubleshooting and implementing RF power systems in a manufacturing environment.
• Work experience in a regulated environment, preferably pharmaceutical.
  
  

Minimum Qualifications

• Must be at least 18 years of age
  
  

Travel Requirements

• Typically requires travel less than 5% of the time
  
  

Physical Requirements And Work Environment

• General office area.
• May need to enter controlled and cleanroom manufacturing areas.
• May be required to work in areas in excessive of 100ºF.
• Adequate mobility to climb ladders, kneel, and squat 10% or less of the time.
• Ability to occasionally lift up to 40 lb. unassisted.
  
  

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical LLC is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.