Sr. Process Engineer

POSITION OVERVIEW

Syner-G is seeking a Senior Process Engineer with 8+ years of experience in oral solid dose (OSD) pharmaceutical manufacturing to lead process optimization and commercial manufacturing support activities. The role focuses on improving and sustaining robust OSD processes across granulation, compression, coating, and packaging operations. The Senior Process Engineer will support technology transfer from development to commercial manufacturing, troubleshoot complex process and yield issues, and provide technical leadership during PPQ and continued process verification activities. Acting as a key technical partner to MSAT, Manufacturing, QA, and Engineering, the engineer will drive process robustness, efficiency, and compliance across client programs.

WORK LOCATION

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

KEY RESPONSIBILITIES

Lead process optimization for oral solid dose manufacturing processes, including granulation, compression, coating, and packaging. Support technology transfer activities from development and pilot operations into commercial manufacturing, ensuring process scalability, robustness, and reproducibility. Troubleshoot process deviations, yield losses, equipment challenges, and cycle time constraints in commercial OSD manufacturing environments. Provide technical support for process validation activities, including PPQ execution and continued process verification. Collaborate closely with MSAT, Manufacturing, Quality, and Engineering teams to resolve technical issues and implement sustainable process improvements. Develop and maintain process documentation such as process descriptions, equipment specifications, risk assessments, and technical reports. Conduct data analysis and performance trending to identify root causes, variability drivers, and improvement opportunities. Support commissioning, qualification, and start‑up activities for OSD manufacturing equipment. Drive continuous improvement initiatives focused on throughput, yield, cost reduction, and GMP compliance. Mentor and support junior engineers by providing technical guidance and process expertise.

QUALIFICATIONS AND REQUIREMENTS

Education BS or MS in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical field. Experience 8+ years of experience in oral solid dose pharmaceutical manufacturing. Hands‑on experience with tablet presses, granulators, fluid bed systems, and coating equipment. Demonstrated experience supporting tech transfer and commercial manufacturing operations. Direct involvement in PPQ, continued process verification, and commercial process support. Proven ability to collaborate in cross‑functional GMP environments. Technical Skills Strong knowledge of GMP requirements and pharmaceutical manufacturing regulations. Solid understanding of OSD unit operations, process controls, and equipment capabilities. Experience investigating deviations, leading root cause analyses, and implementing corrective and preventive actions. Strong communication skills and the ability to serve as a technical lead across functions. Ability to manage multiple priorities in a fast‑paced manufacturing environment.

ESSENTIAL FUNCTIONS

Physical Demands The employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as lift and carry objects weighing up to 25 pounds. Occasionally required to stand, stoop, or kneel. Vision abilities required: close vision and the ability to adjust focus. Work Environment Moderate noise level, indoor temperate environment, bright light levels conducive to minimal eye strain—typical for an office or manufacturing environment.

TOTAL REWARDS PROGRAM

Market‑competitive base salary and annual incentive plan, robust benefit offerings, flexible paid time off, company‑paid holidays, flexible working hours, and full‑remote work options for most positions. Physical location options include Greater Boston, San Diego, CA, Boulder, CO, and India.

LEGAL STATEMENT

Syner-G is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy, personal appearance, family responsibilities, sexual orientation, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, veteran status, disability, or any other basis prohibited by law. Syner-G is an E‑Verify employer. #J-18808-Ljbffr Syner-G BioPharma Group