Project Engineer

Overview

Project Engineer role at Bimeda. Reporting to the Plant Manager, the Project Engineer position is accountable for execution and support of high value, complex & strategic capital projects primarily at the Bimeda Sterile Manufacturing Site in Cambridge, Ontario. The Project Engineer will perform process engineering design to select appropriate equipment technology for a given process, prepare detailed capital project request reports and execute project plans for various Engineering projects. The role includes evaluating and controlling the project execution process, monitoring, data collection, reporting and communication with stakeholders for the manufacturing equipment and systems implementation.

Demonstrates an expert level of operational knowledge of sterile and non-sterile product manufacturing and related processes to add value to investigations, evaluations and recommendations. Maintains a thorough understanding of GMP, GDP, regulatory guidance, safety and environmental controls, and incorporates regulatory requirements into written documents. Briefs stakeholders and senior management on regulatory implications for projects and timelines.

Responsibilities

• Perform process engineering design to select appropriate equipment and technology for a given process.
• Prepare and execute competitive tender processes – vendor assessment, tender execution, evaluation and reporting.
• Prepare detailed capital project reports for various engineering projects.
• Oversee project implementation, ensuring design criteria, safety standards, budgets, timelines and all project matters are met.
• Collaborate with Vendors and Bimeda validation team to develop IQ / OQ / PQ protocols and summary reports for equipment, facilities, computerized systems, cleaning and manufacturing processes.
• Prepare, revise and update schedules for project execution and validation activities.
• Engage with stakeholders to define project requirements, justify approaches and manage solutions within cost, quality, compliance, safety and delivery targets.
• Review and propose changes to SOPs based on equipment capabilities and operation.
• Utilize advanced statistical tools to analyze process data from investigations, manufacturing batches and design of experiments.
• Work with multiple departments to develop SOPs, Preventive Maintenance programs, and calibration for equipment / instrument / facility / start-up.
• Assess equipment, support systems and facility modifications for impact, revalidation needs, downtime reduction and efficiency improvements.
• Implement and improve cradle-to-grave equipment lifecycle plans aligning with Asset Management strategies.
• Assess and improve asset maintenance strategies; identify mitigation for asset failure risk; analyze asset performance trends and propose improvements.
• Develop lifecycle models to justify asset life extension, replacement and upgrade programs.
• Communicate effectively with all levels of the company and present solutions to Senior Management and stakeholders.
• Write, review and approve protocols and reports in support of projects.
• Ensure compliance with Safe Work Practices (SWP), SOPs, and environmental, health & safety requirements.
• Collaborate across departments and escalate issues as needed; support issue resolution for junior staff.
• Adhere to all compliance programs and company policies; may require overtime or weekend work as needed.

Qualifications

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products with over half a century of experience. The company operates six R&D centers across four continents, nine manufacturing facilities across seven countries and focuses on the development, manufacture and commercialization of Bimeda-branded products as well as contract manufacturing and R&D services for the animal health industry.

How to apply

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