The Process Engineer is responsible for providing engineering, maintenance and project management support for our pharmaceutical, biopharmaceutical, and medical device manufacturing clients. Responsibilities include optimization of the equipment, systems and utilities, oversee/support the installation start-up and qualification activities associated with cGMP Manufacturing and Laboratories.
- Support the installation, start-up, commissioning, maintenance, and qualification of Facilities equipment, systems and utilities to ensure the installation and operation of equipment to design and manufacturer’s specifications.
- Provide technical and engineering e support including review and comment on specifications and protocols for process equipment and utilities.
- Demonstrate a strong understanding of HVAC, mechanical and electrical systems, and troubleshoot as necessary.
- Collaborate with Maintenance and Metrology groups to develop programs for equipment maintenance and calibrations.
- Provide support with Corrective Action/Preventative Action (CAPA), change control, deviations etc.
- Monitor and respond to alarms generated from the BMS/QEMS.
- Develop standard operating procedures.
- Ensure safe working conditions.
- Other duties as required.
- BS or MS in Engineering field is required, or equivalent experience.
- 5 years of related process & manufacturing in Pharmaceutical industry experience required.
- Experience of aseptic process is preferred.
- Experience in equipment design, installation, and qualification
- Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
- Experience interfacing with other design disciplines including automation, facility design and mechanical design groups is required.
- Experience interfacing with CQV and operations teams is required.
- Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
- Experience using Building Management Systems and Environmental Monitoring Systems is preferred.
- Demonstrable experience on cGMP capital, maintenance and operating projects.
- Excellent oral and written communication skills required.