||Prince Edward Island
||Process engineer will focuses on the design, operation, control, and optimization of Engineering upstream & downstream processes for the manufacture of vaccines.
Functions, Duties, Task:
Provide stewardship for process and equipment including
Implementation and optimization of Process systems
- Review the basis for the qualification of equipment and ensure that the equipment/system is appropriate for intended purpose
- Ensure significant changes, maintenance and other interventions do not impact the qualified state of the equipment & provide maintenance oversight for process equipment.
- Conduct or oversee periodic reviews of direct impact facilities, utilities equipment and systems to verify that they remain in state that is fit for their intended use
- Create & revise qualification packages for direct impact systems & work with TSMS to ensure the accuracy of process flow documents
- Provide oversight to less experienced engineers
Execute local engineering projects
- Serve as local subject matter expert for process engineering systems
- Ensure process operations comply with all Health, Safety, and Environmental policies and procedures.
- Ensure process operations are in alignment with current site interpretations of GMPs & Elanco quality standards
- Perform/ oversee Haz-ops and other process safety reviews.
- Know and understand throughput and capacity, and implement improvements and problem solving to optimize the system performance.
- Network with system users to ensure their needs are always met.
- Provide Process Engineering support to project team
- Participate as required in teams, committees or other groups to achieve goals
- Work with project requester to determining the scope of the project.
- Write user requirements document.
- Complete Environmental Assessments
- Write and execute commissioning documents to verify project success
- Revise drawings and P&ID’s as needed and organize drafting updates
- Confirm CADD revisions and sign drawings.
- Assist in development of training plans & execute training as required
- Review, revise & create Process Engineering documentation, validation requirements & user requirements as required
Write change management, incident reports, and complete corresponding action items
- Act as investigation lead for Deviations related to Process systems and apply Root Cause Analysis to the investigation.
- Complete documentation review for items generated or completed by the other process engineers and technicians. Provide technical assistance and backup support as necessary to these individuals.
- Monitor all training requirements as defined in the ITP for this position, and ensure that training is completed by the required completion date.
- Ensure that all necessary items are entered in the quality plan and that items are completed by the required date
- BS Degree level in Chemical or Mechanical Engineering
- 2-5 years experience with process engineering principles
- Experience in a pharmaceutical, Biotech or related environment preferred
- Proven analytical thinking and trouble-shooting skills
- Strong oral, written, and interpersonal communication skills
- Demonstrated ability to work independently and be a self-starter
- Proven ability to multi-task
- Strong attention to detail
- Experience in validation activities associated with aseptic process, technology transfer and process validation
- Experience in FMEA ,QRM, P&ID development, PFD development
- Exposure to Lean-Six sigma principles
- Experience in fermentation and cell technology