Senior MSAT Process Engineer

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent! The Sr. Process Engineer will provide process support and technical expertise to clinical and commercial client manufacturing processes for advanced cell therapies. This role will usher processes and programs through their lifetimes within the Memphis Cell Therapy manufacturing facility. This role will be instrumental in gathering and performing real-time in-process review of process parameters (i.e., cell counts, viability, flow, etc.). There will be a large emphasis on aseptic process simulation design and reports as well as facilitating process impact assessments.

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.
• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
• Opportunities to grow your technical expertise and take ownership of your work.
• Close interaction with leadership and clients, enabling real influence on project outcomes.

Responsibilities

• Work as part of a cross-functional team to ensure maximum and high-quality output of deliverables for clients.
• Complete tasks to facilitate routine manufacturing operations and/or complex internal projects independently.
• Serve as Subject Matter Expert (SME) on process validation reports/reviews, APS design and final reports, and PPQ protocols and execution.
• Support the evaluation of impact assessments for QMS documentation.
• Serve as SME on key product quality attributes and how they can be impacted by process and equipment functionality.
• Lead assessments of client manufacturing requirements against internal capabilities to identify any equipment or facility gaps.
• Perform complex/critical investigations to support QMS documents and/or continuous improvement.
• Build and foster client relationships; act as POC for client programs.
• Own, monitor, and report on departmental KPIs.
• Lead cross-functional continuous improvement initiatives at the site level.
• Serve as SME on annual process validation reviews, process documentation, and MS&T deliverables (reports, protocols, etc.).
• Provide support for process and equipment-related investigations and support the operations team to address any adverse events.
• Monitor and analyze transferred process performance (Manufacturing) and troubleshoot technical difficulties as requested by management.
• Ensure tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
• Travel may be required for training or process transfer activities.
• Perform all other related duties as assigned.

Requirements

• BS/MS in engineering or life sciences.
• Minimum 10 years or equivalent applicable experience.
• Knowledge of equipment and processing in cell culture and/or cGMP processing.
• Detail-oriented with excellent organizational skills.
• Effective written and oral communication skills.
• High degree of professionalism and confidentiality.
• Initiative to remain apprised of relevant industry and regulatory trends.

Preferred qualifications:

• Experience with design software (AutoCAD, BlueBeam, or SolidWorks).
• Experience with statistical software (MATLAB or JMP).
• Experience in equipment commissioning, FAT, SAT, and qualification.

Pay

The pay range for this position is $110,200 - $123,200 per year.

Physical Demands

• Must be able to sit/walk for long periods of time.
• Must be able to lift, push, pull up to 10 lbs. routinely; 20 lbs. occasionally.
• Must be able to work standing, bending, and reaching overhead occasionally.
• Must be able to move sufficiently between multiple office and facility locations.
• Must have visual acuity to use a keyboard, computer monitor, and operate equipment.

Benefits

• Competitive base salary with performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company contribution.
• Generous PTO and professional development support.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.
• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.