Process Engineer II
Listed on 2026-07-18
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Engineering
Process Engineer, Quality Engineering, Validation Engineer
At Rose Bio Solutions, 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 Process Engineer II 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. It will be instrumental in gathering and performing real‑time in‑process review of process parameters (e.g., cell counts, viability, flow, etc.). The role includes a large emphasis on aseptic process simulation design and reports, as well as facilitating process impact assessments.
Key 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 with some support from PE's and management.
- Monitor, trend, and report on process data.
- Draft APS protocols with input from Senior Engineers.
- Investigate and close major deviations.
- Build knowledge of how key product quality attributes can be impacted by process and equipment functionality.
- Assess client manufacturing requirements against internal capabilities to identify any equipment or facility gaps.
- Generate PPQ protocols and execute them.
- Support annual process validation reviews with necessary documentation.
- Support APS design and final report documentation.
- Investigate process and equipment‑related issues and support operations with adverse events.
- Monitor and analyze transferred process performance and troubleshoot technical difficulties as requested by management.
- Ensure tasks are performed consistently with safety standards and within cGMP guidelines.
- Travel may be required for training or process transfer activities.
- Perform all other related duties as assigned.
- BS/MS in engineering or life sciences.
- Minimum 1.5 years of applicable experience.
- Knowledge of equipment and processing for cell culture and/or cGMP processing.
- Detail oriented with excellent organizational skills.
- Strong written and oral communication skills.
- Professionalism and confidentiality.
- Initiative to remain apprised of relevant industry and regulatory trends.
- Experience with design software (AutoCAD, Blue Beam, or Solid Works) – a plus.
- Experience with statistical software (MATLAB or JMP) – a plus.
- Experience in equipment commissioning, FAT, SAT, and qualification – a plus.
The pay range for this position is $70,000 – $85,000 per year.
Benefits & Perks- 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 Bio Solutions is an equal opportunity employer committed to a diverse and inclusive workforce.
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