Packaging Development Specialist

Work Schedule

Environmental Conditions

Job Description

How will you make an impact?

Responsible for the design, modification, support, and improvement of packaging processes at the development, validation, and commercial stages for assigned clients.

What will you do:

• Provide technical leadership for the design and evaluation of packaging processes with a focus on Quality by Design and the use of technology and automation to obtain repeatable, efficient, and safe processes.
• Lead and/or participate in problem solving for packaging activities, equipment and processes.
• Prepare documentation for Risk Assessments, Engineering Line Trials, and Packaging Development Reports for assigned clients.
• Prepare Master Batch Records for Pharmaceutical Development Services and Commercial Operations for assigned clients. Drives required changes to Master Batch Records through change controls as required.
• Provide packaging expertise and project support to clients during meetings and on-site visits.
• Collaborate with Project Management, Business Management, Process Pharmacy, Technical Transfers, Validation, Planning, Materials Management, Analytical and other functional areas to meet project and team objectives.
• Perform alternating or rotating shifts as required

How will you get here:

Education:

College/Technical School diploma in relevant technical field.

Experience:

Minimum 3 years previous related experience within a manufacturing/pharmaceutical environment.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

General understanding of drug packaging processes. 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. Familiarity with current Good Manufacturing Practices. Ability to recommend improvements relating to pharmaceutical packaging, equipment, processes and systems. Actively acquires new skills/knowledge relevant to drug packaging processes. Draws on experience and demonstrates innovative approaches to problem solving. Works autonomously under general direction to meet project and team objectives. Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry. Advanced experience in MS Word/Excel and demonstrated computer proficiency with other Microsoft Office programs. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

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 extremes, 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.