Process Engineering Specialist

2 months ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Process Engineering Specialist to join our team at Thermo Fisher Scientific. As a key member of our Technical Operations department, you will be responsible for providing technical support to our Operations teams and collaborating with our Pharmaceutical Development Services team to ensure seamless process development and implementation.

Key Responsibilities
  • Provide technical support to Operations teams, including process scale-up, process optimization, and technology transfer.
  • Investigate quality issues, including system control, quality investigation reports, and quality deviation reports.
  • Investigate root causes and recommend corrective actions/preventative actions for the Technical Operations department.
  • Generate technical documents, including protocols, reports, proposals, gap/risk assessments, batch records, and user requirements specifications.
  • Generate, assess, and approve change controls.
  • Attend quality improvement meetings and collaborate with cross-functional teams to drive process improvements.
  • Support the coordination of project information between Account Management, Quality Assurance, Quality Control, and Commercial Operations.
  • Assist in the design and acquisition of equipment and perform batch analysis.
  • Attend key project team meetings, client teleconferences, and on-site visits.
  • Interact with clients daily and work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities.
  • Provide training and support to Co-Ops/Interns and monitor ongoing training.
  • Maintain a safe working environment and report potential hazards.
  • Perform alternating and rotating shift work as required.
Requirements
  • Post-secondary diploma in Chemistry, Engineering, Science, or a related field.
  • BSc in Chemistry or Engineering is an asset.
  • Minimum 6 years of combined hands-on pharmaceutical experience in Production and Development, including scale-up and technology transfer of solids and liquids.
  • Minimum 3 years of experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation.
  • Previous experience in statistical analysis and data compilation.
  • Previous experience with SAP enterprise software to source information and navigate business operations.
  • Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
  • Familiarity with pharmaceutical regulations (FDA, ICH, ISPE, and best industrial practices).
  • Thorough knowledge of processing/packaging equipment.
  • Thorough knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
  • Possess a highly developed quality, regulatory, and production mindset with an appreciation for client service and the contract manufacturing industry.
  • Strong written and oral skills.
  • Detail-oriented and organized, with a high degree of accuracy and thoroughness.
  • Excellent interpersonal skills and communication skills.
  • Ability to multi-task, meeting tight deadlines in a fast-paced environment.
  • Proven problem-solving abilities.
  • Demonstrated computer proficiency with 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, modeling 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.
  • 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 engaging 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 fields.
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.
  • May be exposed to mild physical discomfort from factors such as dust, fumes, or odors, 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.

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