Sr. Fill Finish Process Engineer (Future Opportunities)

Position Overview:

Support the capital project buildout of a new commercial fill–finish suite within a commercial manufacturing facility. Apply expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, equipment technologies, GMP operations, and regulatory expectations.

Work Location:

Travel to client sites may be required up to 100% based on project phase and client needs.

Key Responsibilities:

• Support design, construction, installation, and qualification of a commercial fill–finish suite.
• Contribute to user requirements, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities.
• Troubleshoot technical issues and support continuous improvement.
• Maintain validated aseptic manufacturing processes and GMP documentation.
• Ensure alignment with FDA, EMA, ICH, and Annex 1 requirements.
• Coordinate engineering, operations, facilities, quality, and validation activities.

Qualifications and Requirements:

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering, or a related technical field.
• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Sterile, aseptic, biologics, or vaccine fill–finish experience is preferred.
• Experience with commercial manufacturing, commissioning, qualification, and engineering documentation.
• Strong understanding of aseptic operations, cleanrooms, and fill–finish equipment.
• Strong documentation, communication, analytical, technical writing, and problem-solving skills.

Essential Functions:

The role requires computer use, walking, sitting, reaching, talking, listening, and occasionally standing, stooping, kneeling, lifting, and carrying objects up to 25 pounds. The work environment is indoors with moderate noise and office-like conditions.

Total Rewards Program:

The company offers competitive compensation, benefits, flexible paid time off, paid holidays, flexible working hours, remote work options for most positions, and career development opportunities. Syner-G is unable to sponsor or take over sponsorship of an employment visa at this time.

Legal Statement:

Syner-G is an equal employment opportunity and affirmative action employer. Employment decisions are made without regard to legally protected characteristics.