Process Engineering Lead

2 weeks ago

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

We are seeking a highly skilled Technical Operations Manager to join our team at Thermo Fisher Scientific. As a key member of our Process Engineering team, you will be responsible for leading the development and implementation of manufacturing processes and technologies.

Key Responsibilities

  • Mentor and guide the Process Engineering team to increase their level of knowledge and expertise.

  • Lead the execution of projects for products transitioning into the site, ensuring speed and success of implementation aligns with site capabilities and capacity.

  • Ensure a smooth and orderly transition of projects from Development to Operations, ensuring batches completed in the Good Manufacturing Practices areas meet regulatory requirements.

  • Collaborate with Operations staff on product process issues and troubleshooting, providing scientific and technical input to support conclusions and resolutions.

  • Review batch records for containment, safety, and accuracy of process, developing proposed process trains for new products entering the commercial plant.

  • Provide technical assistance with 24-hour shift coverage for trial, feasibility, or pre-commercial batches, tracking quality performance trends and keeping CAPA actions on track.

  • Schedule and manage day-to-day activities, preparing and circulating departmental activity reports and schedules, including team metrics.

  • Lead client interactions during validation observation visits, supporting site on new business initiatives through client visits and proposal generation.

  • Promote a safe working environment, reporting potential hazards, and ensuring direct reports follow Environmental Health and Safety procedures.

  • Select, develop, and evaluate staff to ensure efficient operation of the function, working with staff on administrative policies and procedures.

Requirements

  • College/Technical School diploma in a related technical field, Bachelor's degree in engineering, Science, or related field preferred.

  • Minimum 7 years' experience in Manufacturing, Quality, Technology Transfer, or relevant contract manufacturing cGMP regulated environment.

  • Minimum 3 years' supervisory experience, previous project management and/or client experience.

  • Strong knowledge and understanding of manufacturing/operational processes, Good Manufacturing Practices, and FDA compliance.

  • Excellent interpersonal and communication skills, ability to motivate and influence, meet deadlines, and prioritize multiple project deliverables.

  • 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, 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.

  • 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 field.

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