Senior Process Engineer

BridgewaterFull Timesenior

EngineeringProcess Engineer

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Technical Tools

EngineeringProcess Engineer

Position Summary

We are seeking an innovative and highly motivated Senior Process Engineer on our MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform.

This position is responsible for supporting the activities involved in development, process transfers, compliance, and scalability for Cellares’ manufacturing operations. This individual will focus on technology transfers from Process Development into GMP manufacturing facilities, as well as driving and developing process automation and scalability solutions to improve process reliability, safety, cost-effectiveness, scalability, and compliance.

This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be a resident expert in the areas of technology transfer and manufacturing science and technology. It is expected that this individual will work closely with other corporate functional areas and partners to ensure deliverables are met. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies

Work as the MSAT representative on client projects

Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers

Lead Master Validation Plan creation in order to support PPQ campaigns

Lead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholders

Support development of manufacturing operations including GMP system implementation and tasks related to GMP readiness

Support process development and process comparability activities on Cellares technology as required

Support development and review of relevant SOPs for manufacturing operations and systems. Author and review global program policies Perform manufacturability assessments for new process introductions

Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies

Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS

Work with our software team to provide feedback on internal software solutions

Provide technical support to Manufacturing and other departments associated with GMP operations

Support or author product quality impact assessment for major deviations. Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations

Maintain and report process run summaries, and continued process verification reports

Prepare and present data associated with manufacturing processes to internal and external partners

Support for process qualification and validation preparation, execution, and reporting

Work with clients on process mapping of the manufacturing processes

Other duties as assigned

Bachelor’s Degree in a scientific or related field is required

A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy

Experience in the Pharma/Biotech industry in technology transfer

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site

Adherence to cGMPs is required all times during the manufacture of Cell Therapy products. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions

Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus

Must have experience writing, reviewing and approving GMP documentation

Self-motivated and passionate about advancing the field of cell therapy

Self-awareness, integrity, authenticity, and a growth mindset

Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level

Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines.