Our client’s bio-pharmaceutical manufacturing plant is in need of a Plant Engineer to provide engineering technical support to meet FDA guidelines in GMP environment. As Plant Engineer will implement procedures and guidelines that ensure consistent and compliant operation of equipment with repeatable and reproducible results.
ESSENTIAL AREAS OF RESPONSIBILITY
Execution of commissioning, installation and operational qualification, and protocols for equipment, mechanical, computer control, and utility systems.
Follow Qualification Master Plans, process flow diagrams, test cases, and SOP’s
Execution of Test Protocols, including identification and resolution of non-conformances/deviations.
Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
Preparing specific User Requirements Specifications (URS).
Provide active inputs/participation in FATs, SATs.
Bachelor’s in Engineering required (Chemical or Mechanical preferred)
3+ Years’ experience - at least 3 years working experience in commissioning, qualification and/or validation activities in Pharmaceutical or related manufacturing environment.
This is a 3 month contract position with possibility for extension or direct hire