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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
