Manufacturing Documentation & Systems Specialist

Cook Inc - Bloomington; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Inc - Bloomington is seeking a Manufacturing Engineering Specialist, Documentation to provide direct technical support for documentation, equipment procurement, testing, operational excellence, and training. You will collaborate with multiple company functions to ensure equipment and production systems operate safely and with quality.

The role requires maintaining training, following GMP/quality standards, and ensuring compliance with FDA 21 CFR 820 and ISO 13485.

Qualifications

• AS or BS degree in a relevant field or equivalent experience.
• Ability to work independently with minimal supervision.
• Proficiency with Microsoft Office and AgilePLM software.

Responsibilities

• Produce, organize, and maintain documentation critical to the engineering team's function.
• Support short- and long-term projects and complete key tasks for Cook, Inc projects.
• Install and qualify equipment in production areas.
• Develop or revise drawings, work instructions, and standard operating procedures.
• Prepare prototype work orders and manufacturing documentation; perform related testing.
• Lead change orders within AgilePLM as needed.
• Manage multiple projects and support documentation efforts.
• Troubleshoot documentation issues as needed.
• Maintain knowledge of team focus and company systems (e.g., jBase, AgilePLM, Opcenter).
• Mentor and train team members within area of expertise.

Skills

Independent work

Documentation

Attention to detail

Education

AS or BS degree

Tools

AgilePLM

Opcenter

Excel

Job description

Cook Inc - Bloomington is seeking a Manufacturing Engineering Specialist, Documentation to provide direct technical support for documentation, equipment procurement, testing, operational excellence, and training. You will collaborate with multiple company functions to ensure equipment and production systems operate safely and with quality.

The role requires maintaining training, following GMP/quality standards, and ensuring compliance with FDA 21 CFR 820 and ISO 13485.