Syner-G · 5 hours ago
Sr. Process Engineer
Waltham, MA
Full-time
Onsite
Senior Level
7+ years expSyner-G is a company dedicated to enhancing lives through the development of life-enhancing therapies. They are seeking a Sr. Process Engineer with expertise in aseptic pharmaceutical or biologics manufacturing to support the buildout of a new fill-finish suite within a commercial manufacturing facility, ensuring compliance and performance improvement in manufacturing operations.
HealthcareManufacturingPharmaceuticalHealth Care
No H1B
Responsibilities
Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure
Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews
Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines
Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P&IDs, and GMP requirements
Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection
Partner with Operations and MS&T to troubleshoot and resolve technical issues
Collaborate with Maintenance and Reliability teams to address equipment performance gaps
Support continuous improvement and process optimization initiatives
Partner with QA, Validation, and MS&T to maintain validated state of aseptic manufacturing processes
Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1
Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring
Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports
Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages
Develop and execute commissioning and qualification protocols
Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus
Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution
Participate in project planning, scheduling, risk assessments, and milestone tracking
Provide effective communication to stakeholders at all levels
Qualification
Required
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
Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience
Experience supporting commercial manufacturing operations in a regulated environment
Experience with commissioning, qualification, and engineering documentation
Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment
Strong documentation and technical writing skills
Ability to manage multiple priorities in a fast-paced environment
Strong communication, analytical, and problem-solving skills
Ability to work independently and collaboratively
Preferred
Experience with digital validation platforms such as KNEAT
Benefits
Market competitive base salary and annual incentive plan
Robust benefit offerings
Generous flexible paid time off program
Company-paid holidays
Flexible working hours
Fully remote work options for most positions
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Board Member
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