Senior Engineer, Technical Operations

Replimune•Framingham, MA

1d•$146,000 - $189,000•Onsite

About The Position

The Technical Operations Senior Engineer will be responsible for providing drug substance, drug product, and/or secondary packaging technical support for oncolytic virus manufacturing. This includes life cycle management of commercial processes, including ownership and support of change controls, CAPAs and deviations. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

Minimum of 4 years working in biologics drug substance and/or drug product process development / manufacturing support role.
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 characterization, Process Performance Qualification (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

Cross functional leadership and technical oversite of an oncolytic virus manufacturing process at the site’s manufacturing facility.
Manage technology transfer and post transfer manufacturing support. Provide technical leadership in troubleshooting issues with product processing technologies and equipment.
Provide effective life cycle management through CAPA/Change Control execution and deviation resolution.
Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of experimental findings
Monitor commercial process performance, perform evaluation of continuous process verification data and trends, investigate possible variability and identify opportunities for process improvement.
Conduct process optimization modeling and lead implementation of process improvements.
Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions
Collaborate cross functionally with other departments to ensure efficient execution of commercial manufacturing process and transfer of new assets and process enhancements.
Author protocols, reports, SOPs, and other technical documentation
Lead and facilitate process risk assessments (e.g., FMEA, risk analyses, and impact assessments) to identify potential risks, implement mitigation strategies, and support robust process performance, product quality, and regulatory compliance.
Assist with authoring sections of applicable regulatory filings to support change requests to the commercial process
Support the review, assessment, and implementation of supplier change notifications to ensure compliance, product quality, and continuity of supply.
Support Process Performance Qualification (PPQ) and commercialization activities, including technology transfer, process validation, manufacturing readiness, and cross-functional execution to ensure successful product launch and sustained commercial performance.
Practices and promotes safe work habits and adheres to safety procedures and guidelines
Provide technical representation during internal and external audits
Keeps up to date with current technologies and trends in biologics manufacturing operations and support