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GL Staffing Services, Inc.

Manufacture process engineer

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Job Description

A growing pharmaceutical/biotechnology company is seeking a motivated Associate Scientist / Manufacturing Engineer to support formulation and manufacturing process development for sterile liquid and inhalation drug products. This role will focus on process development, manufacturing support, equipment troubleshooting, scale-up, fill-finish operations, and GMP documentation . The successful candidate will work closely with Manufacturing, Quality, QC, Formulations, Analytical Sciences, and other cross-functional teams to develop and maintain robust, scalable, and compliant manufacturing processes. The ideal candidate has hands-on experience in pharmaceutical manufacturing or process engineering , with experience troubleshooting manufacturing equipment and familiarity with sterile/aseptic processing and GMP documentation.
Employment Type:
Contract Location:
Coral Spring, Florida Department:
Research & Development Compensation:
$32-$37/hour
Schedule:
1st
Shift:
7:00 AM-5:00 PM or 2nd
Shift:
4:00 PM-2:00 AM Key Responsibilities Support development, optimization, and scale-up of pharmaceutical manufacturing processes. Provide technical support for formulation, sterile filtration, filling, aseptic processing, inspection, and finishing/packaging operations . Troubleshoot manufacturing equipment and process issues and identify appropriate corrective actions. Support process improvements, process characterization, and manufacturing scale-up activities. Create, revise, and maintain SOPs, batch records, manufacturing instructions, protocols, reports, and other GMP documentation . Support engineering batches, clinical manufacturing, process validation, PPQ activities, and continued process verification. Analyze manufacturing and process data to identify trends and support process improvements. Support technology transfer from development into manufacturing. Participate in investigations, deviations, CAPAs, change controls, and root-cause analysis. Support sterile liquid and inhalation drug product development. Work with manufacturing equipment used for formulation, filtration, filling, inspection, and packaging. Collaborate with cross-functional teams and external partners to support manufacturing and commercialization activities. Maintain compliance with cGMP requirements, safety procedures, and company policies . Minimum Qualifications Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry , or a related scientific or engineering discipline. 2-5 years of experience in pharmaceutical manufacturing, process engineering, manufacturing engineering, process development, or a related technical role. Experience working in a GMP/cGMP manufacturing environment . Experience supporting manufacturing processes and/or pharmaceutical production operations. Experience with process and equipment troubleshooting . Experience creating, reviewing, or revising SOPs, batch records, manufacturing instructions, or other GMP documentation . Strong analytical, troubleshooting, and problem-solving skills. Experience analyzing technical/manufacturing data and preparing technical reports. Preferred Qualifications Experience with sterile or aseptic pharmaceutical manufacturing . Hands-on experience with fill-finish or filling operations . Experience with sterile filtration and aseptic processing. Experience with pharmaceutical manufacturing equipment. Experience with process validation, PPQ, engineering batches, or technology transfer. Experience supporting deviations, CAPAs, investigations, and change controls. Experience with inhalation, respiratory, or drug-device combination products. Familiarity with process characterization, DOE, and statistical analysis. Working Conditions Full-time, onsite position in a laboratory, pilot plant, and cGMP manufacturing environment. Routine work in classified cleanroom environments requiring appropriate gowning and adherence to aseptic processing and contamination-control procedures. Hands-on interaction with laboratory, pilot-scale, and manufacturing equipment. Regular support of manufacturing campaigns, development studies, technology transfer, and validation activities. Ability to stand, walk, bend, reach, and lift up to 50 pounds as required. May require extended periods in controlled manufacturing areas and schedule flexibility to support manufacturing operations.