Syner-G
Sr. Process Engineer
Bedford, Massachusetts, United States · Senior
Sponsorship not specifiedDetected 20 days ago
Process ImprovementProcurementPLCMechanical DesignGMPLeadershipCommunicationMentoringSCADA
About the role
- Travel to client sites may be required up to 100%, based on project demands and client expectations.
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.
- 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.
Requirements
- 10+ years of experience in process engineering, manufacturing engineering, CQV, or related engineering disciplines within pharmaceutical, biotech, or sterile injectable manufacturing environments.
- 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 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.
Nice to have
- BS/MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, Pharmaceutical Engineering, or a related technical field preferred.
- Experience supporting filling line integrations with vendors such as OPTIMA, Syntegon, IMA, or equivalent suppliers is preferred.
Skills
- Expertise in commissioning, qualification, startup, performance verification, and operational readiness methodologies.
- A career here is life-enhancing.
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