The PositionSupport development and install of new equipment and process for Aseptic and Finished production to meet future business and regulatory requirements thru the following activities: Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus and Standards "Gatekeeper".
This position will be supporting Aseptic Production - Wash & Sterilization. The ideal candidate will have a strong backround in cleaning and sterilization processes, including hands-on experience with autoclaves, automated washers, clean-in-place (CIP), and steam-in-place (SIP) systems. Experience supporting, troubleshooting, and optimizing these systems in a pharmaceutical manufacturing environment is preferred.
RelationshipsReports to Manager, AP Equipment.
Essential Functions- Development of new equipment and processes for our Aseptic and Finished Production areas
- Coaching & mentoring Engineering & Maintenance Technicians
- Support technical development of process and standards of the process
- Employ advanced cLEAN® tools within the main areas of problem solving, project & change management
- Work closely with global team and vendors in technical design and development of equipment
- Responsible for install and qualification of new equipment and processes as part of the engineering team
- Work closely with global team in development of the new equipment and/or pilot processes
- Maintain & establish standards for procedures & maintenance plans
- Acts as Diabetes Finished Products (DFP) Technology Network team member for their process
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.
Qualifications- Bachelor's Degree in engineering/related field or equivalent (experience + education) required
- Minimum 5 years engineering experience in Maintenance, Design, Process Improvement, cLean® 2 Star or Six Sigma Green Belt certification preferred
- Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM) preferred
- Proven expertise in planning/organization/execution of maintenance activities, following up on results preferred
- Revising the work plan for complex problems being resolved by cross functional teams preferred
