Engineer III, Commercial Packaging

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Join Thermo Fisher Scientific to support the Packaging Engineering of Commercial Drug Products. This role includes design, development, qualification, documentation, and implementation of secondary packaging including labels, inserts, instructions for use, cartons, and more. You will support manual, semi-automatic, and fully automatic packaging of ambient and cold chain commercial drug products including auto injectors. Additionally, you will lead serialization activities including Master Data Management, Print & Apply Label Design, Client Connectivity Set Up and Testing, and Data Transfer Problem Solving.

A day in the Life:

Engineering Responsibilities:

• Perform component and packaging design for Tech Transfer project results with regular interaction between Client and Vendor.

• Guide and coordinate multiple project tasks from inception to completion with reliable project management approaches.

• Focus on long-term continuous improvement activities through interaction with Engineering and Operations Staff.

• Recommend and lead methods for improving efficiency and reducing waste through PPI initiatives.

• Complete deviation investigations, change controls, and corrective/preventative actions.

• Author/edit Standard Operating Procedures and Work Instructions as necessary.

• Develop and perform packaging test protocols and reports as needed to support line trials, distribution studies, and other package testing.

• Support problem-solving of operations-related issues.

• Stay updated on industry trends, materials, and technologies to continuously improve packaging strategies.

Serialization-Specific Responsibilities:

• Assist in tech transfer onboarding and connectivity activities for new and existing partners, including client master data coordination.

• Develop Optel recipes for production, including integration of client master data and label layouts.

• Design serialization labels aligned with client requirements using Codesoft labeling software.

• Lead testing for serialization equipment and system connectivity.

• Maintain and update SOPs related to serialization to align with global and local compliance frameworks.

• Be responsible for the setup and ongoing production of serialization equipment and collaborate with Tracelink or other EPCIS providers.

Keys to Success:

Education

• BS Packaging Science or similar technical field or equivalent experience.

Experience

• Minimum 3 years packaging engineering experience.

• Existing knowledge and proven competence in packaging engineering.

• Strong understanding of artwork development (no artwork creation).

• Experience with packaging development and material evaluation.

• Technical ability and firsthand experience in packaging design and testing.

• Packaging equipment familiarity.

Preferred Qualifications:

• Prior experience with Serialization.

• Prior experience in pharmaceutical setting.

• Experience with child-resistant packaging.

• Experience with thermoforming.

• Experience with product contact packaging systems.

• Experience with DSCSA (Drug Supply Chain Security Act), HDA (Healthcare Distribution Alliance) compliance (GS1 and FDA guideline support), and other serialized market regulations.

• Experience with Tracelink or equivalent EPCIS providers.

• Experience with serialization equipment/system setup and equipment validation.

• Experience with label design