The Pharmaceutical Engineering Manager is responsible for leading a team in the development and implementation of production equipment and processes in order to provide a safe and efficient working environment, essential to the performance of the business. This position reports to the Director of Facilities.
Duties and Responsibilities
- Develop and implement processes for the preventative maintenance program for manufacturing equipment per standards in the industry and equipment manufactures’ recommendations.
- Assist in developing schedule for and performing major engineering projects and facility modifications. Coordinates maintenance shutdowns with the Director of Facilities to ensure the availability of resources for timely completion to maximize compounding capability.
- Implements changes for improving manufacturing line efficiencies and maintenance performance.
- Responsible for calibration program.
- Responsible for equipment qualification and validation (FAT/SAT/IQ/OQ/PQ protocol creation and/or execution).
- Interacts with and manages contractors for validation as required. Coordinates with material/equipment vendors as well.
- Performs quality investigations in a timely manner regarding deviations, out of tolerance conditions, unexpected results on facility issues by conducting failure analysis, root cause determination, and corrective action determination
- Drive continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness.
- Leads change control processes related to equipment and facilities
- Works with manufacturing team for equipment operations training and implementation program.
- Write SOP’s, OSW’s, etc. to document processes.
- Assist with safety assessments for modifications to equipment.
- Develop and deliver ongoing training to staff regarding utilities equipment and hazards.
- Utilize facility engineering principles to solve straight forward problems. Work with production on a daily basis to coordinate appropriate course of action to maximize uptime and quality performance of respective area.
- Interface with Director of Facilities to complete requested engineering projects in a timely manner.