OTHER REQUIREMENTS

Essential:

• Bachelor’s degree or higher in Chemical, Mechanical, or Industrial Engineering.
• 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
• Meets all deadlines associated with projects as directed, including all reports and documentation as directed.
• Keep the North American Plant 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
• 5 years experience

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 (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.
  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 one’s own department’s 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