Technical Project Leader I – Packaging Engineering

at  Thermo Fisher Scientific

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. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

• 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 packaging equipment projects.
• Own the 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 objectives.
• Perform alternating or rotating shift work as required.