Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Summary:
Support/Lead client packaging development projects from initial design to ongoing commercial production.
Essential Functions:
Lead the Project Management for implementation of project specific packaging equipment, new market launches and serialization requirements where applicable.
Work with Global Serialization team and outside Vendors to coordinate changes to Serialization
systems.
Contribute to the development of Risk Assessments, Packaging Engineering Line Trial protocols / reports and Packaging Master Batch Records.
Participate in the development of client packaging serialization requirements.
Support qualification of ERP systems related to serialization.
Support coordination and execution of engineering line trials that involves components, scheduling, training, documentation, serialization, etc.
Manage 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.
Participate in continuous improvement activities as needed.
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work as required.
REQUIRED QUALIFICATIONS
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.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
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.
Knowledge, Skills and Abilities:
Extensive knowledge and understanding of drug packaging processes as well as drug product validation and commercialization processes. Demonstrates organizational skills relevant to drug packaging. Strong written and oral communication skills. Extensive knowledge and experience with experimental design. Detail oriented and organized, with a high degree of accuracy and thoroughness.