Senior Process Engineer

Responsibilities

• Lead the design, installation, commissioning, qualification, and startup of pharmaceutical lyophilization systems
• Serve as technical lead for lyophilizer integration within aseptic filling and finishing facilities
• Provide technical leadership during facility design, equipment specification, and procurement
• Review engineering deliverables including PFDs, P&IDs, and functional specifications
• Lead Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs)
• Coordinate integration between lyophilizers, aseptic filling lines, SCADA systems, and PLCs
• Manage interface management between filling line OEMs and lyophilizer vendors
• Support GMP documentation including change controls, deviations, and CAPAs
• Mentor and support junior engineers through technical leadership and coaching

Requirements

• 10+ years of experience in process engineering or CQV within pharmaceutical or biotech environments
• Extensive experience with pharmaceutical lyophilization (freeze-drying) systems
• Proven track record integrating lyophilizers with aseptic filling and finishing operations
• Strong knowledge of sterile manufacturing, aseptic processing, and Annex 1 compliance
• Experience with SCADA, PLC, DCS, and manufacturing automation platforms
• Ability to develop and interpret PFDs, P&IDs, and functional specifications
• Strong project management and stakeholder management skills

Preferred Qualifications

• BS/MS in Chemical Engineering, Mechanical Engineering, or Bioprocess Engineering
• Experience with Tofflon lyophilization systems
• Experience with filling line vendors such as OPTIMA, Syntegon, or IMA

About the Company

Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and the delivery of life-enhancing therapies to patients. Recognized as one of BioSpace's "Best Places to Work," Syner-G fosters a culture of growth, innovation, and meaningful real-world outcomes.