Project Engineer

Job Description

Job Description

Salary : Role Summary

Reporting to the Plant Manager, 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

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. 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.

Key Role Specific Requirements

• Perform 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.
• Works with various departments in the development of Standard Operation Procedures (SOPs), Preventive Maintenance (PMs), 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 Bimedas assets which support Asset Managements long-term strategies and objectives.

Please note that this job description is not exhaustive and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and / or priorities and requirements evolve.

Competencies Required for the Role

FOSTERING COLLABORATION / TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

PROCESS IMPROVEMENT involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.

RESULTS ORIENTED The ability to focus on the desired result of ones own departments work, setting challenging goals, focusing on the goals, and meeting or exceeding them.

ANALYTICAL THINKING / PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

Other Requirements

Essential :

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a centurys experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the worlds animals.

Bimedas global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimedas ten manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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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.