Process Development Engineer

A growing pharmaceutical/biotechnology company is seeking a motivated Manufacturing process 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.