Receive alerts when this company posts new jobs.
Engineering Coordinator I
at TOLMAR Inc.
Purpose and Scope
The Engineering Coordinator I is responsible for the coordination, control, and tracking of artwork and components. Responsibilities also include creating, managing, revising, and tracking company documents and product configurations. This position also provides support for maintaining existing procedures, forms, and engineering reports as well as the creation of technical documents for future products, equipment and procedures.
Essential Duties & Responsibilities
- Utilizes the EDMS (electronic document management system) to create/revise inspection specifications for device and packaging components and artwork.
- Coordinates proposed document changes with the appropriate department using a Request Management System.
- Creates and revises documentation required for materials management and manufacturing, i.e., pick lists, batch records, and work instructions using the electronic document system.
- Creates and modifies in-house labels using a label design software.
- Creates and modifies Linear and 2D Data Matrix Bar Codes, according to HDA Guidelines, for use in artwork by marketing partners or Tolmar.
- Manages communication and technical verification of die lines and artwork through all stages of product life.
- Develops and reviews processes, work instructions, and standard operating procedures and implements improvements within guidelines.
- Supports the writing of engineering quality investigations, and assist with CAPA plan creation for investigations.
- Investigates non-conformance events and determines root cause, corrective and preventive actions.
- Assists with Supplier Change Notifications, Protocols, and Reports.
- Effectively communicates with a broad range of internal and external customers in written and verbal formats.
- Completes training on company procedures as required to ensure compliance with requirements.
- Performs other duties as assigned.
Knowledge, Skills & Abilities
- Previous experience with electronic document management systems preferred.
- Working knowledge of cGMP, GDP, and QA/QC principles.
- Experience with artwork specifications used for printed packaging materials.
- Experience using Microsoft Office Suite and Adobe Creative Suite.
- Proficient in Microsoft Word.
- Ability to manage and prioritize multiple projects and tasks demonstrating strong organization and time management skills.
- Strong oral and written communication skills.
- Ability to work well independently and collaboratively with others.
- The Engineering Coordinator I is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
- High school diploma or GED required.
- Bachelor’s Degree strongly preferred.
- At least two years of previous experience in a regulated industry (pharmaceutical, biotechnology or medical device) preferred.
- Working conditions are in an office, laboratory and manufacturing environment.
- Occasional weekend and/or evening work may be required.