Process Engineer

Job Description

Job Description

Position : Sr. Process Engineer

Location : United States, , Palm Beach County

Status : Full Time, Permanent

Category : Engineering

Overview :

Develop and establish maintenance / engineering tools / programs to ensure that the facility is kept in a good state of repairs as well as all process equipment are cGMP compliant from a facility, maintenance and engineering perspective.

Direct, evaluate and assist capital engineering and process improvement projects.

Facilitate requisitions or equipment and parts.

Serve as equipment / facility expert and interface with regulatory agencies on audits etc.

Develop efficient PM plans for all key pieces of manufacturing equipment etc. and provide troubleshooting expertise in all areas of plant operations and maintenance.

Assist in and or champion investigation of deviations that are facilities / maintenance related, Train SMEs in problem solving techniques and ensure the appropriate corrective actions are taken.

Assist in writing regulatory documents for FDA submission as required

Continuously monitor the manufacturing operation to look for process optimization, debottlenecking opportunities and make technical engineering recommendations and / or changes as necessary.

Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.

Qualifications :

Bachelor’s degree in Mechanical, Biochemical, or Chemical Engineering.

Minimum 5 years of process engineering / project engineering experience in a cGMP, Pharmaceuticals, Biological manufacturing environment.

Must have the ability to apply engineering theory, practices and principles to determine root cause of equipment failures and to perform equipment performance evaluations.

Please apply with your updated resume.