Senior Engineer, Biologics Operations & Process Excellence

Replimune; Framingham (MA); On-site; USD 146,000 - 189,000; Full time

Job summary

Replimune is seeking a Technical Operations Senior Engineer to provide drug substance, drug product, and packaging technical support for oncolytic virus manufacturing at the Framingham site. The role emphasizes lifecycle management, CAPA/Change Control, and process optimization within a 5-day on-site expectation.

Ideal candidates have 4+ years in biologics process development/manufacturing, strong technical writing, and experience with PPQ/CPV and single-use technologies.

Qualifications

• Minimum of 4 years working in biologics drug substance and/or drug product process development / manufacturing support.
• Experience with setting up, supporting, and troubleshooting multiple pieces of drug substance, drug product and/or packaging equipment (e.g. production bioreactors, TFF skids, chromatography skids, fill machine).
• Experience with single-use manufacturing technologies.
• Experience with process validation lifecycle activities, including Process Validation (PPQ), Continued Process Verification (CPV), and commercialization.
• Experience conducting process risk assessments using tools such as FMEA, risk analysis, and change impact assessments.
• Strong technical writing skills with experience authoring and reviewing validation protocols, reports, risk assessments, and technical documentation.
• Proficiency with data analysis and statistical tools (e.g., JMP, Excel) for process performance evaluation and decision-making.
• Experience supporting commercial manufacturing processes in a regulated environment.
• Demonstrated ability to work in cross-functional teams across the business.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills and strong team member

Responsibilities

• Lead cross-functional oversight of the oncolytic virus manufacturing process at the site.
• Manage tech transfer and post-transfer manufacturing support; troubleshoot processing technologies.
• Provide life cycle management through CAPA/Change Control and deviation resolution.
• Drive process improvements through technological innovation and data trends.
• Monitor process performance; evaluate data and identify opportunities for improvement.
• Lead process risk assessments (FMEA, etc.) and mitigation strategies.
• Author protocols, reports, SOPs and regulatory documentation.
• Support PPQ, process validation, and commercialization activities.

Skills

Biologics

Process validation

CAPA & Change Control

FMEA

Data analysis

Cross-functional

Education

Master's degree in chemical or biomedical engineering

Bachelor's degree in chemical or biomedical engineering

Tools

JMP

Excel

Job description

Replimune is seeking a Technical Operations Senior Engineer to provide drug substance, drug product, and packaging technical support for oncolytic virus manufacturing at the Framingham site. The role emphasizes lifecycle management, CAPA/Change Control, and process optimization within a 5-day on-site expectation.

Ideal candidates have 4+ years in biologics process development/manufacturing, strong technical writing, and experience with PPQ/CPV and single-use technologies.