Technical Project Leader I - Packaging Engineering

at  Thermo Fisher Scientific

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.

EDUCATION:

College/Technical School diploma in relevant technical field.

EXPERIENCE:

Minimum 3 years of previous related experience and general knowledge of a drug packaging, validation or packaging production.
Experience in packaging technical/scientific discussions with clients.
Previous Project Management experience an asset.

KNOWLEDGE, SKILLS AND ABILITIES:

General understanding of drug packaging processes and sterilization. Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrates organizational skills relevant to drug packaging. Strong technical writing and oral presentation skills. General knowledge of experimental design. General understanding of drug product validation and communication. Ability to recommend improvements relating to pharmaceutical packaging, equipment, processes and systems. Actively acquires new skills/knowledge relevant to the drug packaging process. Draws on experience and demonstrates innovative approach. Works autonomously under general direction to meet project and team objectives. Established quality, regulatory, and production mentality including an appreciation for client service and the contract manufacturing industry. Proven computer proficiency with Microsoft Office programs. Proficiency with the English language.

• Lead the Project Management for implementation of packaging equipment, new market launches and serialization requirements where applicable.
• Work with Global Serialization team and outside Vendors to coordinate changes to Serialization systems.
• Write protocols / reports for packaging engineering line trials.
• Support coordination and execution of engineering line trials that involves components, scheduling, training, documentation, serialization, etc.
• Support complex packaging equipment projects.
• Handle completion of equipment Corrective Action Preventative Actions (CAPA’s).
• Support implementation of improvements into batch records.
• Liaise with functional areas (including clients and vendors) to meet project objectives.
• Perform alternating or rotating shift work as the need arises.