Engineer II - Labeling

Integer Holdings Corporation

1d•Onsite

About The Position

This role is responsible for planning, scheduling, conducting, and coordinating detailed phases of the labeling process. The Engineer II - Labeling prepares, creates, and controls labels and Instructions for Use, including managing updates throughout the product life cycle. This position involves tracking and maintaining labeling documents, reviewing them for accuracy and adherence to guidelines, and initiating Change Control Requests for labeling updates. The role also includes uploading and maintaining UDI databases, investigating new labeling process technologies, preparing project documentation, and striving for continuous improvement. Communication with internal and external customers regarding labeling updates, executing new labeling for product development and production, and collaborating with cross-functional teams are key aspects of this position. Additionally, the role manages labeling translation activities, reviews product specifications for labeling requirements, supports packaging and label validation, ensures compliance with regulatory standards, and provides support for regulatory submissions and packaging equipment validation. Technical support for label printing and database management is also required.

Requirements

Bachelor’s degree in a related field or 3+ years of experience in GMP, FDA, Change Control process.
Strong written and oral communication skills.
Strong attention to detail.
Strong organizational and time management abilities.
Demonstrated ability to work in a team environment.
Strong understanding of Regulatory labeling landscape.
Strong proficiency with Microsoft Office.
Strong proficiency with Adobe InDesign.
Strong proficiency with Adobe Illustrator.
Knowledge and understanding of label creation software.
Strong understanding of Regulatory labeling landscape.

Responsibilities

Plans, schedules, conducts, and coordinates detailed phases of the labeling process.
Prepares, creates, and controls labels and Instructions for Use, including updates.
Tracks and maintains labeling documents using process tools for revision control.
Reviews labeling documents to ensure accuracy, formatting, and adherence to guidelines.
Initiates and/or implements Change Control Requests pertaining to labeling updates.
Follows through on open Change Control Requests and evaluates impact assessments.
Performs upload and maintains applicable UDI databases (e.g., FDA UDI GUDID, EUDAMED).
Investigates, contributes, and supports new labeling process technologies.
Prepares all necessary paperwork and documentation for projects.
Strives for continuous improvement and consistency in deliverables.
Communicates with internal and external customers regarding ongoing labeling updates.
Executes new labeling in support of new product development and current production.
Collaborates with cross-functional teams to ensure labeling deliverables are on-track.
Prepares and manages labeling translations activities.
Collaborates with cross-functional teams to review product specifications and evaluate requirements.
Supports the execution of Packaging and Label Validation Plans and Reports.
Ensures packaging and labeling follows regulatory, customer, and specification requirements.
Provides support with internal and external Regulatory submission packages.
Supports the validation of packaging equipment and labeling equipment (IQ, OQ, PQ).
Supports Value Stream manufacturing teams for packaging and labeling projects.
Provides technical support for label printing and database management.
Performs other duties as required.