About the role:
Reporting to the North American Projects Manager, and as part of the Global Engineering & Operational Excellence Group, the Project Engineer position is accountable for execution and support of high value, complex & strategic capital projects primarily in the Bimeda Sterile Manufacturing Site in Cambridge, Ontario and will also provide similar support in Bimeda’s two US manufacturing plants located in Le Sueur, Minnesota and Irwindale, California as directed by the North American Projects Manager.
The Project Engineer will perform basic process engineering design to select appropriate equipment technology for a given process. Prepare detailed capital project request reports and execution project plans for various Engineering projects. Evaluate and control the execution process of the projects, conduct monitoring, acquire data, generate reports and communicate with all stakeholders and other support requirements for the manufacturing equipment and systems implementation.
Demonstrates an expert level of operational knowledge of sterile & non-sterile product manufacturing and/or other related and complimentary manufacturing processes to add value to investigations, evaluations and recommendations.
Demonstrates a thorough understanding of good manufacturing practices (GMP), good documentation practices (GDP), regulatory guidance requirements, safety and environmental controls. Accurately incorporates regulatory requirements governing proposed changes into written documents. Briefs stakeholders and senior management on the implications of regulatory requirements on projects and their timelines.
What you'll do:
- Perform basic process engineering design to select appropriate equipment and technology for a given process.
- Prepare and execute competitive tender process – vendor assessment, tender execution, evaluation, reporting.
- Prepare detailed capital project request reports for various engineering projects.
- Project implementation, ensuring throughout that the design criteria, safety standards, budgets, timelines, and all other project matters are met.
- Develop with Vendor and Bimeda validation team IQ/OQ/PQ protocol development and summary reports for equipment, facilities, computerized systems, cleaning and manufacturing processes.
- Prepare, revise and update schedules for project execution and validation activities.
- Research and develop project requirements through the engagement of key stakeholders, propose and justify approach and successfully project manage solutions while strictly adhering to cost, quality, compliance, safety and delivery targets.
- Reviews and proposes changes to SOPs based on expert knowledge of equipment capabilities and operation.
- Utilizes advanced statistical tools for analyzing process data from investigational trials, commercial manufacturing batches and Design of Experiments.
- Understands and interprets standard and non-standard laboratory test results. Proposes appropriate non-standard testing in order to advance investigations and evaluations.
- Works with various departments in the development of Standard Operation Procedures (SOPs), Preventive Maintenance (PM’s), and calibration programs at equipment/instrument/ facility/process start-up.
- Performs equipment, support systems and facility modification, repair and maintenance assessments for impact study, determine revalidation requirements, downtime reductions, and overall equipment availability and efficiency improvements.
- Implement and improve “cradle to grave”- Equipment Life Cycle plans for Bimeda’s assets which support Asset Management’s long-term strategies and objectives.
- Assess the effectiveness of Bimeda’s existing asset, equipment and systems - maintenance strategies and provide recommendations for improvement where necessary.
- Identify and analyze factors that contribute to asset failure risk and identify mitigation options and control measures.
- Capture and analyze asset performance trends and provide recommendations for improvement where necessary.
- Implement and evolve lifecycle models and methodologies which provide reasoning and justification for asset life extension, replacement, and upgrade programs.
- Effectively communicates and builds relationships with all levels within the company. Presents solutions and solicits feedback from Senior Management and stakeholder groups.
- Responsible for writing, reviewing and approving protocols and reports in support of projects.
- Works in compliance with all established Safe Work Practices (SWP) and the company SOPs and operational SOPs. Understands the requirements and responsibilities for Environmental, Health & Safety and ensures that these applied.
- Works collaboratively with others in the same department and with all stakeholders to achieve agreed objectives. Assists with resolving issues escalated from more junior staff. Escalates issues further, rapidly and as necessary.
- Ensures adherence with all compliance programs and company policies and procedures.
- Coordinates and manages all site Insurance renewal surveys for Bimeda. Risk assess, action and direct the closure of all insurance related deficiencies together with advising Executive and Senior management regarding options to mitigate current and potential risks.
- Provides support to North American Projects Manager with large scale projects.
What you bring to the role:
Education & Experience:
- Bachelor’s degree or higher in Chemical, Mechanical, or Industrial Engineering.
- P. Eng. Or P.Eng. candidate.
- Familiar with GMP, FDA, HPB, and ISO requirements.
- Preferably five years’ experience working in the pharmaceutical industry or Food Industry
- Available to travel to sister Bimeda sites to support projects as directed by North American Projects Manager
- Meets all deadlines associated with projects as directed, including all reports and documentation as directed.
- Keep the North American Projects Manager up to date on project schedules.
- Ensures continuous professional development by regular literature review.
- Conforms to all the principles of cGMP and to conform with all relevant departmental and other company standard operating procedures.
- Should be flexible to work over-time and Weekends.
- PLANNING – is the process of thinking about and organizing the activities required to achieve a desired goal.
- FLEXIBILITY -The ability to be open to different and new ways of doing things; willingness to modify one’s preferred way of doing things. Is able to see the merits of perspectives of others than his/her own.
- PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
- LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.
- CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage.
What We Offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Insurance
- Pension plan
- Employee Assistance Program
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.