Process Engineering Specialist

The Process Engineer is responsible for ensuring the reliability, compliance, and performance of manufacturing processes, equipment, utilities, and computerized systems within a pharmaceutical or biotechnological environment.

Requirements

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field)
• Demonstrated experience in oral solids manufacturing processes, specifically tablets
• Previous experience in handling problem solving and research associated with tablet manufacturing equipment and processes (mixing, compression, coating, compaction in Roller Compactor)
• Extensive experience in process engineering, validation, metrology, and quality assurance within pharmaceutical or biotech manufacturing
• Strong knowledge of 21 CFR Part 11, GAMP, and validation of automated systems (SCADA, PLCs, HVAC, water systems, utilities)
• Demonstrated ability to perform technical troubleshooting on equipment and computerized systems
• Experience with investigations, deviations, and CAPA management
• Experience in project management, facility start‐ups, equipment commissioning, and system upgrades
• Proficiency in developing protocols, SOPs, risk assessments, and validation documentation
• Strong communication, teamwork, and leadership skills

Benefits

• Confidentiality of information according to EEO guidelines