What are the responsibilities and job description for the Process Engineer position at Blueroot Health®?
Description
PURPOSE STATEMENT:
The Process Engineer – Technical Services is responsible for driving process improvement, scale-up readiness, and operational stability across commercial products. This role supports the organization’s 2026 capacity expansion and COGS reduction objectives by ensuring products can be manufactured reliably, efficiently, and compliantly at scale.
The role operates within a defined decision framework. Product Development retains ownership of product intent, claims, innovation, ingredient selection, and pre-launch formula definition. Technical Services leads to scale-readiness, post-launch process optimization, and formula adjustments to ensure stability, manufacturability, and reduced rework. Quality maintains change control authority. Manufacturing is responsible for executing production activities and owning overall operational performance.
What You’ll Do (major Responsibilities)
This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.
PURPOSE STATEMENT:
The Process Engineer – Technical Services is responsible for driving process improvement, scale-up readiness, and operational stability across commercial products. This role supports the organization’s 2026 capacity expansion and COGS reduction objectives by ensuring products can be manufactured reliably, efficiently, and compliantly at scale.
The role operates within a defined decision framework. Product Development retains ownership of product intent, claims, innovation, ingredient selection, and pre-launch formula definition. Technical Services leads to scale-readiness, post-launch process optimization, and formula adjustments to ensure stability, manufacturability, and reduced rework. Quality maintains change control authority. Manufacturing is responsible for executing production activities and owning overall operational performance.
What You’ll Do (major Responsibilities)
- Process Improvement and Operational Excellence
- Drive yield improvement, scrap reduction, and OEE enhancement initiatives across commercial products.
- Optimize blending, encapsulation, tableting, and bottling processes to improve robustness and throughput stability.
- Improve cycle times, changeovers, and cost efficiency without impacting product intent or claims.
- Scale-Up and Commercial Readiness
- Lead scale-up readiness assessments for products transitioning from Product Development to Manufacturing.
- Identify manufacturability risks and implement mitigation strategies prior to commercial launch.
- Support effective tech transfer and ensure smooth transition into sustained production.
- Formula Optimization and Rework (Post-Launch)
- Implement formula and process adjustments required for scale, stability, and manufacturability within defined guardrails.
- Lead formula changes required for rework or deviation scenarios in partnership with Quality.
- Design compliant rework strategies and ensure all modifications follow formal change control procedures.
- Technical Problem Solving
- Collaborate with Product Development and Quality on OOS and deviation investigations.
- Lead technical root cause analysis and define corrective and preventive actions.
- Mitigate raw material variability risks in coordination with Product Development and Procurement.
- Decision Scope
- Decision authority includes scale-up readiness, formula changes for rework and deviations, post-launch process parameter adjustments, cost optimization initiatives that do not impact claims, and post-launch technical sustainment.
- All activities operate within Quality change control governance. Product Development retains authority over product intent, claims, and innovation. Manufacturing is responsible for executing operations and delivering performance results.
- Degree in Engineering, Food Science, Pharmaceutical Sciences, or related discipline
- Minimum five years of experience in nutraceutical, pharmaceutical, or regulated manufacturing
- Strong formulation and process troubleshooting expertise
- Experience managing rework within GMP environments
- Demonstrated track record in continuous improvement initiatives
- Moderate degree of physical activity and coordination required
- Must be able to lift up to 50 pounds
- Continuous standing and frequent walking
- Continuous pushing/pulling/lifting/reaching
- Work in moderately loud environment
- Works near moving mechanical parts
- Must wear PPE appropriate for the position: protective eyewear (when needed), non-slip footwear, hair net, beard net (if applicable), nitrile food-grade gloves
This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.