Mechanical/Electrical Engineer

About the role

Reporting to the Lead Mechanical/Electrical Engineer, this position serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation with primary focus on machinery used in the packaging production process. Projects include but are not limited to: manufacturing systems, non-sterile filing systems, packaging systems, process pumps and piping, utility systems, new facility construction and upgrades, Serialization and other packaging control systems and applications.

ESSENTIAL DUTIES / RESPONSIBILITIES

• Engage in technical discussions with potential suppliers
• Organize and write specifications based on the needs and requirements (URS)
• Launch calls for tenders (Request for Proposal, Request for Service)
• Ensure the solution designed respects the established specifications(s)
• Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.
• Execute Projects and Tasks to the approved completion deadlines and within the defined budget
• Work in partnership with external companies
• Propose and apply solutions to mitigate and compensate for possible work delays
• Proactively alert site management to potential problems
• Ensure the successful commissioning of the project
• Monitor the installations and commissioning of equipment
• Coordinate the various suppliers and vendors and ensure their compliance to health and safety instructions
• Possess adequate technical expertise allowing problem resolution
• Respect the data in the specifications
• Communicate with Production to coordinate activities with respect to production constraints
• Absorb and carry out commissioning activities and in putting the equipment into production
• Carry out an assessment after each commissioning
• Writing feasibility and line trials, qualification protocols, execution of the tests, writing and approval of any resulting reports.
• Participate in operator training (training)
• Work with internal customers to define the training requirement and provide technical content
• Organize training in collaboration with suppliers
• As an equipment/process SME, create training documents and deliver training
• Study the technical needs associated with new site investments
• Participate in different project groups
• Collect and analyze needs from internal stakeholders
• Define technical solutions and implementations
• Respect the technical, regulatory and quality requirements issued by Management and Quality Assurance.
• Take into account the necessary parameters (water production, energy, etc.)
• Respect flows, workshop ergonomics and safety constraints
• Ensure the documentation of completed projects is updated
• Create technical drawings of the factory and update according to approved documentation practices

REQUIRED EDUCATION

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience. Master’s Degree considered a plus. Associate’s degree with highly relevant experience will be considered.

QUALIFICATIONS/EXPERIENCE

SPECIFIC SKILLS: This position requires the ability to think in high level terms to develop engineering solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes. Demonstrated ability to perform technical troubleshooting, problem solving. Background related to cGMP manufacturing, filling or packaging systems and equipment a plus. Detailed knowledge of equipment operation and validation requirements. Experience with robotics and vision systems a plus. Ability to work in a matrix organization with cross-functional teams. Ability to specify, procure, oversee installation, and commission systems and processing equipment. Strong project management skills. Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.