Job Description

Summary

This position will be a part of the Regional Process Engineering group with the responsibility of supporting the Solution and Device Facilities in the US & CANADA. It will require a solid understanding of theories and practices utilized by other disciplines outside the primary area of expertise. The use of standard engineering principles and technical leadership will be required to resolve complex problems as well as support, develop, and improve manufacturing processes. This role will involve serving on cross-functional teams to investigate operational deficiencies and to develop/implement improvements to ensure more efficient/effective systems. The ability to interact with all affected functional areas is required to drive the Baxter principles of Safety, Quality, Delivery & Cost and to ensure alignment on our continuous improvement journey.

Essential Duties and Responsibilities:

Must be self-motivated, work independently and be able to prioritize and complete multiple tasks.

Able to work flexible hours as needed to support improvement opportunities.

Devise new approaches to complex problems through adaptations and modifications of standard technical principles.

Helps to establish baseline and target metrics for key processes to drive cost-effective improvements.

Must be able to provide solutions that reflect the understanding of business objectives and cost implications.

Provide guidance, support, and leadership through positive interactions with all personnel during daily operations.

Analyze site processes to understand opportunities where engineering improvements could be implemented to drive VIP’s (Value Improvement Project’s).

Investigate and analyze customer needs to develop innovation that will drive Safety, Quality, Delivery, and Cost in a positive manner.

Perform and document process modifications and system functional specification updates while adhering to documentation and change control requirements.

Optimization and or upgrade of Control (PLC’s, HMI’s, Servo Drives, etc.), Mechanical Systems as well as Robotic operating mechanisms that will support the overall business goals of the site.

Sustain a clean and safe work area using 6S principles.

Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP).

Knowledge, Skill, and Abilities:

In-depth knowledge and experience of equipment and processes in a manufacturing environment

Ability to multitask and work with cross-functional teams.

Strong leadership, facilitation, negotiation, and influencing skills. The ability to drive change.

Strong analytical/statistical problem-solving skills; ability to analyze and interpret statistical data.

Communication and interpersonal skills to work with all levels of the organization, including direct and indirect labor.

Excellent professional writing skills and ability to prepare technical reports. Ability to clearly articulate information during regulatory/client inspections.

Ability to understand regulatory guidelines.

Must be recognized as a technical expert by peers and other personnel within the business unit.

Must have a working knowledge of LEAN tools and methodology to ensure all waste is understood and taken into consideration for improvement opportunities. Lean Thinker.

Knowledge and use of Microsoft Office including Microsoft Project.

Experience in a regulated and Pharmaceutical Good Manufacturing Practice (cGMP) environment is preferred.

Experience in computer-aided design such as AutoCAD (2D and 3D), Solid Works, and Pro-E solid modeling systems.

Must be able to work alone and drive accountability

Required Education and Experience:

Bachelor of Science in Engineering (Automation/Mechatronics Background preferred).

5 -10 years of related experience in a manufacturing environment

Experience with programming and troubleshooting robotics, PLC’s, vision inspection, mechanical and pneumatic systems.

In-depth understanding of Pharmaceutical Solution and Device Manufacturing at the process level

Experience in a pharmaceutical environment writing and reviewing validation and change control documentation

Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

Must have basic English written and oral communication skills (for OUS positions) and Spanish and/or Portuguese preferable (for US roles)

Travel requirements: 50% in Home Facility, 50% travel within the US/Canada region as well as assigned site support.