POSITION OVERVIEW:

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. This individual 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.

The Senior Process Engineer will provide leadership in process engineering, system integration, equipment startup, troubleshooting, and operational readiness activities while supporting continuous improvement and technology transfer initiatives across client programs.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• 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, 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.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.