Sr. Process Engineer

Key Responsibilities

• 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.
• Cook up 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, permissives, 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 continuous improvement initiatives focused on equipment reliability, process robustness, product quality, and operational efficiency.
• Mentor and support junior engineers, providing technical leadership, coaching, and engineering guidance.

Qualifications and Requirements

• Education: BS/MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, Pharmaceutical Engineering, or a related technical field preferred.
• Knowledge, Skills, Experience:
  • 10+ years of experience in process engineering, manufacturing engineering, CQV, or related engineering disciplines within pharmaceutical, biotech, or sterile injectable manufacturing environments.
  • Extensive experience supporting the design, installation, commissioning, qualification, and startup of pharmaceutical lyophilization (freeze-drying) systems for sterile vial manufacturing.
  • Demonstrated experience integrating lyophilizers with aseptic filling and finishing operations, ensuring seamless coordination between upstream and downstream manufacturing processes.
  • Experience supporting facility design, equipment specification, URS development, design reviews, FATs, SATs, commissioning, qualification, and startup activities.
  • Strong experience with sterile injectable manufacturing, aseptic processing, contamination control strategies, and Annex 1 compliance.
  • Demonstrated experience coordinating activities between equipment vendors, OEMs, engineering teams, automation groups, validation organizations, and manufacturing operations.
  • Experience leading interface management activities between lyophilizers, filling lines, SCADA systems, PLCs, and supporting manufacturing systems.
  • Experience developing and reviewing interface lists, control philosophies, equipment tags, alarms, permissives, and interlocks for integrated manufacturing systems.
  • Experience coordinating system integration between filling line OEMs such as OPTIMA and lyophilizer vendors to ensure reliable equipment communication and operational functionality.
  • Demonstrated experience supporting IQ, OQ, PQ, performance qualification, startup, and operational readiness activities for pharmaceutical manufacturing systems.
  • Strong experience with SCADA, PLC, DCS, and manufacturing automation platforms.
  • Experience supporting system integration activities involving process equipment, automation systems, and manufacturing execution architectures.
  • Experience with Tofflon lyophilization systems is highly desirable, including OEM coordination, SCADA integration, and equipment qualification.
  • Experience with equivalent pharmaceutical lyophilizer platforms and OEMs is also acceptable.
  • Experience supporting filling line integrations with vendors such as OPTIMA, Syntegon, IMA, or equivalent suppliers is preferred.
• Technical Skills:
  • Deep understanding of lyophilization process engineering principles, freeze-drying technologies, cycle development support, equipment operation, performance optimization, and process engineering fundamentals.
  • Strong knowledge of sterile manufacturing operations, aseptic filling processes, contamination control strategies, GMP requirements, and regulatory expectations.
  • Expertise in commissioning, qualification, startup, performance verification, and operational readiness methodologies.
  • Strong understanding of automation systems including SCADA, PLCs, HMI platforms, alarm management, interlocks, permissives, control philosophies, and system integration strategies.
  • Ability to develop and interpret PFDs, P&IDs, functional specifications, automation documentation, interface lists, and engineering drawings.
  • Experience performing technical risk assessments, troubleshooting equipment performance issues, identifying startup challenges, and implementing effective mitigation strategies.
  • Strong project management, communication, and stakeholder management skills.
  • Excellent analytical and problem-solving capabilities with the ability to manage complex technical challenges.
  • Demonstrated ability to lead cross-functional teams and collaborate effectively with engineering, automation, validation, manufacturing, quality, and vendor organizations.
  • Ability to manage multiple priorities while maintaining technical excellence, compliance, and project execution objectives.