Senior MSAT Process Engineer for Cell Therapy Impact

Rose BioSolutions; Memphis (TN); On-site; USD 110,000 - 123,000; Full time

Benefits offered by this job

Impact on patient health

No-ego team

Growth opportunities

Client interaction

Competitive base salary + bonus

Health, dental, and vision

401(k) with company contribution

PTO & professional development support

Job summary

Rose BioSolutions in Memphis seeks a Sr. Process Engineer - MSAT to provide process support and technical expertise for clinical and commercial cell therapy manufacturing.

You will drive real-time in-process review of parameters such as cell counts, viability, and flow, and lead aseptic simulation design and reports. The role emphasizes collaboration with clinical and operations teams, PPQ execution, and QMS documentation, with a focus on safety and regulatory compliance in a cGMP environment.

Qualifications

• BS/MS in engineering or life sciences.
• Minimum 10 years or equivalent applicable experience.
• Knowledge on equipment and processing knowledge of cell culture and/or cGMP processing.
• Must be detail oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills.

Responsibilities

• Work as part of a cross-functional team to ensure maximum and high quality output of deliverables for clients.
• Completes tasks to facilitate routine manufacturing operations and/or complex internal projects independently.
• SME on process validation reports/reviews.
• SME on APS design and final reports.
• Supports the evaluation of impact assessments for QMS documentation.
• SME on key product quality attributes and how they can be impacted by process and equipment functionality.
• Leads assessing client manufacturing requirements against internal capabilities to identify any equipment or facility gaps.
• SME on PPQ protocols and execution.
• Performs complex/critical investigations to support QMS documents and/or continuous improvement.
• Builds and fosters client relationships. Acts as POC for client programs.
• Owns, monitors and reports on departmental KPIs.
• Leads cross functional continuous improvement initiatives at the site level.
• SME on the annual process validation reviews.
• SME on process documentation and MS&T deliverables (reports, protocols, etc.)
• SME on APS design and final reports.
• Will provide support for process and equipment related investigations and support to the operations team to address any adverse events.
• Monitor and analyze transferred process performance (Manufacturing) and troubleshoot technical difficulties as requested by management.
• Ensures tasks are performed in a manner consistent with safety standards and within cGMP guidelines.

Skills

Cross-functional collaboration

Attention to detail

Process optimization

Technical writing

Education

BS/MS in engineering or life sciences

10+ years of relevant experience

Tools

AutoCAD

BlueBeam

SolidWorks

MATLAB

JMP

Job description

Rose BioSolutions in Memphis seeks a Sr. Process Engineer - MSAT to provide process support and technical expertise for clinical and commercial cell therapy manufacturing.

You will drive real-time in-process review of parameters such as cell counts, viability, and flow, and lead aseptic simulation design and reports. The role emphasizes collaboration with clinical and operations teams, PPQ execution, and QMS documentation, with a focus on safety and regulatory compliance in a cGMP environment.