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.

Why Rose BioSolutions:

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.

Essential Duties and 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
• Travel may be required for training or process transfer activities
• Some autonomy will be needed for this role
• Perform all other related duties as assigned

Qualifications:

• BS/MS in engineering or life sciences
• Minimum 10 years or equivalent applicable experience
• Candidate has 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
• Must display a high degree of professionalism and confidentiality
• Must demonstrate initiative to remain apprised of relevant industry and regulatory trends
• Experience with design software (AutoCAD, BlueBeam, or SolidWorks), a plus.
• Experience with statistical software (MATLAB or JMP), a plus.
• Experience in equipment commissioning, FAT, SAT, and qualification, a plus.

COMPENSATION DATA:

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 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, operate equipment.

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.

Perks & 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.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.