Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Division/Site Specific Information

Thermo Fisher Scientific offers industry-leading pharma services through our Patheon™ brand, providing an integrated global network of scientific, technical, regulatory, and quality experts committed to helping deliver medicines to patients faster. The Mississauga site supports all phases of drug product development — from early-phase formulation development to clinical trial material to commercial supply — within the same facility using scalable equipment. The site supports non-GMP and GMP work for highly potent and low-potent compounds, complex formulations, pediatric dosage forms, patent-extension strategies, and conventional oral solid dosage forms.

Discover Impactful Work:

Supports/Leads processing, packaging, and client equipment projects from initial design to operations usage.

Day in the Life:

• Identifies new equipment, develops user requirement specifications, arranges capital funding and implements into Good Manufacturing Practice commercial production.
• Schedules and hosts regular project meeting with internal teams, vendors and clients.
• Creates and manages project plans using Project Management tools/applications, to ensure timely delivery of project milestones.
• Leads all project planning activities and cross-functional project assessments, including assessments by IT groups.
• Monitors capital expenditures for equipment projects.
• Leads the Project Management for implementation of complex processing, packaging, PDS, and/or client equipment.
• Provide leadership to Junior Project Managers by supporting problem solving and solution generation on projects, training/mentoring, and supporting project progression.
• Supports improvements, training, troubleshooting and complaint investigation of equipment.
• Creates or provides technical input into protocols / reports for equipment commissioning and qualification.
• Executes/Provides Technical Support to equipment assessments, validation execution, and/or engineering trials, as required.
• Supports equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), as required.
• Liaises with functional areas (including clients and vendors) to meet project objectives.
• Ensure a safe working environment and potential hazards are identified, assessed and escalated during project execution.
• Maintain a continuous improvement mindset and actively participate in and initiate practical process improvement initiatives.
• Monitors and benchmark new developments in pharmaceutical industry related to their area of expertise and/or project to look for opportunities to put Patheon in the forefront of pharmaceutical technology.
• Ability to travel (as required)
• Performs alternating or rotating shift work (as required)

Keys to Success

Education:

College/Technical School diploma in relevant technical field.

University degree in relevant technical field, Engineering Degree is an asset.

Experience:

Minimum 3 years of previous related experience and general knowledge of drug processing, packaging validation and production.

Minimum 2 years Project Management experience.

Experience in technical writing and oral presentation.

Experience organizing complex work.

Experience in technical/scientific discussions with clients.

Equivalency:

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

Knowledge, Skills and Abilities:

General knowledge and understanding of drug processes as well as drug product validation and commercialization processes. Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrable organizational skills relevant to drug processing. Excellent technical writing and oral communication skills. Strong computer skills with advanced experience in MS Word/Excel and Project Management applications. General knowledge and experience with experimental design, related to development equipment. Ability to recommend improvements relating to pharmaceutical processing, equipment, processes and systems. Actively acquires new skills/knowledge relevant to the drug processing process. Draws on experience and demonstrates innovative approach. Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry. Works independently with minimal need for supervision. 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 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.

Compensation

The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.