PharmEng Technology is currently seeking a Sr. Process Engineer for a project in Atlantic Canada. The position is available immediately conditional of a successful interview
Provide stewardship for process and equipment including
· 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
Implementation and optimization of Process systems
· 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.
Execute local engineering projects
· 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
· 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 technologyBS Degree level in Chemical or Mechanical Engineering
· 2-5 years experience with process engineering principles in a pharmaceutical, Biotech or related environment
· 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
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.