Engineer / SR Engineer, Process

Description

Duties & Responsibilities

Process Engineer

• Assist Principal and Senior Process Engineers in facilitating changes to existing production processes. Assist validation of new equipment and changes to existing equipment including document generation.


• Support change control process for changes to production processes and equipment. Responsible for completing various change control action items and documentation as assigned by Principle or Senior level engineers. Documentation includes P'ID drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required.


• Support manufacturing in troubleshooting product and equipment issues. Respond to requests for support from production. Identify improvements to manufacturing process. Improvements may include mechanical, automation, or workflow. Work with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project. Responsible for User Requirement Specification development.


• Assist Principle Process Engineers in the execution of small scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects).


• On larger capital projects, the engineer will work with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design. The engineer will develop specifications (user, functional, and detailed design) for equipment and automation of the equipment.


• Develop and maintain overall knowledge of facility processes and products.


• This position has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new equipment, facilities, and/or utilities.

Sr. Process Engineer

• Facilitates changes to existing production processes.


• Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment.


• Assists with validation of new equipment and changes to existing equipment including document generation.


• Acts as change control owner for equipment and process improvement projects. Coordinate change control meetings.


• Assigns action items for change control.


• Supports manufacturing in troubleshooting product and equipment issues.


• Responds to requests for support from production.


• Identifies improvements to manufacturing process. Improvements may include mechanical, automation, or workflow.


• Works with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project.


• Responsible for User Requirement Specification development.


• Assists Principal Process Engineers in the execution of small-scale capital projects up to around $500,000, process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects).


• On larger capital projects, the engineer will work with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design. The engineer will develop specifications (user, functional, and detailed design) for equipment and automation of the equipment.


• Acts as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance.

Requirements

Process Engineer

• Bachelor of Science Degree in Engineering or related science from accredited institution required.


• Ability to communicate verbally and in writing effectively with all levels of corporate and local management and employees.


• Ability to plan, schedule, organize, prioritize, and coordinate assigned tasks.


• Ability to understand and work within a regulated environment.


• Experience with GAMP Automation practices and documents preferred.


• Ability to function in a leadership role as well as in a team environment.


• Ability to manage multiple projects at one time.

Sr. Process Engineer

• Bachelor of Science Degree in Engineering from an accredited school with one to three (1-3) years applicable experience in a GMP environment or Bachelor´s degree with three to five (3-5) of engineering or scientific experience outside of a GMP environment.


• In lieu of years of experience, Master´s Degree in relevant field from an accredited school with one (1) year experience in a GMP environment or at least one (1) year of engineering or two (2) years of scientific experience outside of a GMP environment.


• At least one (1) year of experience leading projects preferable.

Competencies:

• Effective verbal and written communication with all levels of corporate and local management and employees.


• Ability to plan, schedule, organize, prioritize, and coordinate project activities.


• Ability to understand and work within a regulated environment.


• Experience with GAMP Automation practices and documents preferred.


• Ability to function in a leadership role as well as in a team environment.


• Ability to manage multiple projects at one time.

Skills:

• Analytical Thinking


• Communication


• Customer Focus


• Decision Making


• Planning and Organizing


• Teamwork


• Conceptual / Analytical Thinking Scope


• Delivering Results


• Leadership

Desired Skills, Experience and Abilities