Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, 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
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position will report to the Mississauga, Canada site, and support the Drug Product Division (DPD).
Thermo Fisher Scientific Inc. is seeking a highly motivated and skilled Project Manager - Equipment Engineering to join our exceptional team. To support and leads processing, packaging, and client equipment projects from initial design to operations usage.
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 leads project plans using Project Management tools/applications, to ensure timely delivery of project landmarks.
Coordinates all project planning activities and multi-functional project assessments, including assessments by IT groups.
Supervises capital expenditures for equipment projects.
Owns the Project Management for implementation of sophisticated 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, solving and complaint investigation of equipment.
Creates or provides technical recommendations into protocols / reports for equipment commissioning and qualification.
Carries out Technical Support for equipment assessments, validation execution, and/or engineering trials, as requested.
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 identify, assess, and advance any potential hazards during project execution.
Maintain a continuous improvement demeanor 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:
College/Technical School diploma in relevant technical field is required.
University degree in relevant technical field, Engineering Degree is an asset.
Minimum 3 years of previous related experience and general knowledge of a drug processing and packaging validation and production.
Minimum 2 years Project Management experience.
Experience in technical writing and oral presentation.
Experience organizing sophisticated work.
Experience in technical/scientific discussions with clients.
Equivalency:
Equivalent combinations of education, training, and meaningful work experience may be considered.
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. Proven 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 outlook including an appreciation for client service and the contract manufacturing industry.
Works independently with minimal need for supervision.
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 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 to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI's) 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 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.