Sr. Process Engineer

About Syner-G

Syner-G is a strategic biopharma product development and delivery partner that supports organizations through the critical phases of drug discovery, approval, and commercialization. We focus on antimicrobial, viral, and other drug development, with a culture that emphasizes learning, growth, and recognition of our people.

Syner-G is seeking a Senior Process Engineer with 10+ years of experience supporting the design, installation, commissioning, qualification, startup, and operational readiness of pharmaceutical manufacturing systems within GMP-regulated environments. This role will serve as a technical lead for lyophilization (freeze‑drying) systems supporting sterile injectable and aseptic vial manufacturing operations.

The ideal candidate will possess extensive experience integrating lyophilizers with aseptic filling lines, automation platforms, and manufacturing systems while providing technical oversight throughout the project lifecycle, including facility design, equipment specification, procurement, installation, commissioning, qualification, startup, performance verification, and commercial operation. The candidate will collaborate closely with engineering, automation, validation, manufacturing, quality, and equipment vendors to ensure successful project delivery while maintaining compliance with GMP requirements and regulatory expectations.

• Travel to client sites may be required up to 100% based on project demands and client expectations.

• Lead the design, installation, commissioning, qualification, startup, and operational readiness of pharmaceutical lyophilization systems supporting sterile vial manufacturing operations.
• Serve as the technical lead for lyophilizer integration within aseptic filling and finishing facilities, ensuring alignment between upstream and downstream manufacturing processes.
• Provide technical leadership during facility design, equipment specification development, user requirements specification (URS) creation, design reviews, and equipment procurement activities.
• Review and support development of engineering deliverables including process flow diagrams (PFDs), P&IDs, process descriptions, functional specifications, equipment specifications, and engineering studies.
• Lead and support factory acceptance tests (FATs), site acceptance tests (SATs), commissioning activities, and qualification execution for lyophilization systems and related equipment.
• Support process engineering activities related to lyophilization cycle development, process optimization, equipment performance evaluation, and manufacturing readiness.
• Coordinate integration activities between lyophilizers, aseptic filling lines, SCADA systems, PLCs, automation platforms, and supporting manufacturing systems.
• Lead interface management efforts between filling line OEMs, lyophilizer vendors, automation suppliers, and project stakeholders to ensure proper system functionality and communication.
• Develop and review interface lists, control philosophies, equipment tags, alarm strategies, per missives, interlocks, and automation requirements for integrated manufacturing systems.
• Support coordination and technical oversight between filling line OEMs (including OPTIMA and similar vendors) and lyophilizer suppliers to ensure successful equipment integration and startup.
• Collaborate with automation teams to develop, review, and optimize automation strategies, control narratives, and system integration requirements.
• Lead commissioning, qualification, and startup activities for process equipment, automation systems, and integrated manufacturing platforms.
• Provide technical oversight during IQ, OQ, and PQ execution activities while ensuring compliance with project requirements and regulatory expectations.
• Support equipment performance verification, operational readiness assessments, and manufacturing startup activities.
• Troubleshoot complex startup challenges, equipment issues, process deviations, automation failures, and integration concerns.
• Identify technical risks and develop mitigation strategies to support successful project execution and operational reliability.
• Partner with engineering, automation, validation, manufacturing, quality, and operations teams to drive project execution and system performance.
• Conduct process analysis, performance trending, and root‑cause investigations to identify opportunities for process optimization and improvement.
• Lead technology transfer and scale‑up activities while ensuring process consistency and manufacturing readiness.
• Manage vendor relationships and coordinate equipment modifications, upgrades, and performance improvement initiatives.
• Support GMP documentation development, review, and approval activities including change controls, deviations, CAPAs, investigations, and qualification documentation.
• Ensure compliance with GMP regulations, aseptic processing requirements, contamination control strategies, and Annex 1 expectations.
• Drive…