The Engineer is overall responsible as an Equipment System Owner for several Biotechnology process equipment and single use systems as well as provide technical support to day-to-day manufacturing activities.
The role will be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues. Experience in design, qualification, operation, maintenance and improvement of Biotechnology process equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall Biotech processes knowledge will be required to perform complex troubleshooting activities.
- Responsible for operation and reliability of Biotechnology process equipment and single use systems assigned.
- Apply process equipment knowledge to perform troubleshooting of equipment failures/malfunctions and the development of technical assessments.
- Develop, implement and optimize maintenance and reliability activities such as preventive maintenance, jobplan and datasheet development.
- Apply knowledge of Operational Excellence practices such as lean maintenance to drive continuous improvement.
- Responsible for investigation of deviations, development of corrective and preventive actions and implementation of change controls in a timely manner.
- Responsible for completion of process equipment periodic review, data integrtity assessment and security assessment in a timely manner
- Complete complex or novel assignments requiring development of new and/or improved engineering technologies, techniques and procedures.
- Serve as a peer-recognized engineering technology specialist.
- Collect, organize, analyze and present results for operational issues or engineering projects of various scale and complexity.
- Work independently and/or with project mangers to complete engineering projects of various scales within schedule, budget and quality constraints
- Responsible for commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment
- Participate in the system walkdown, ensure the closure of punch items and support the takeover of the system from the project team
Basic Education & Experience
- Master’s degree OR
- Bachelor’s degree & 2 years of directly related experience OR
- Diploma & 8 years of directly related experience
EA License No : 19C9587