Engineer - Formulation

Location: Middletown, DE, United States; on-site

Company

hirify.global provides pharmaceutical and biotechnology development and manufacturing services.

What you will do

• Serve as the primary equipment subject matter expert for sterile formulation systems, including weighing and dispensing, solution preparation, mixing, sterile filtration, bulk holding, transfer, and CIP/SIP systems.
• Provide engineering support across the equipment lifecycle, including design reviews, vendor coordination, FAT/SAT, installation, commissioning, qualification, start-up, and routine operation.
• Lead equipment troubleshooting and root cause analysis, implement corrective actions, and drive reliability, preventive maintenance, performance optimization, and continuous improvement.
• Support technology transfer, scale-up, equipment readiness, process implementation, and new product introduction activities.
• Partner with Manufacturing, Technical Services, Validation, Quality, Maintenance, and external vendors on technical and compliance-related activities.
• Support operator and technical training, regulatory inspections, customer audits, and maintenance of equipment in a qualified and controlled state.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 5 years of experience in the pharmaceutical or biotechnology industry.
• Hands-on experience with pharmaceutical formulation systems, including powder handling, weighing and dispensing, solution preparation, mixing, sterile filtration, bulk solution transfer, or bulk holding.
• Experience with CIP/SIP systems and pharmaceutical cleaning and sterilization principles; experience with autoclaves or parts washers is preferred.
• Strong knowledge of cGMP, risk-based approaches, FDA, EMA, ICH, and global regulatory expectations.
• Experience supporting facility start-up or expansion, equipment qualification, deviations, CAPA, change control, and validated-state maintenance.

Culture & Benefits

• Individual contributor position with no direct reports.
• Collaboration across global engineering and cross-functional manufacturing teams.
• Technical interaction with internal stakeholders and external equipment vendors.