Process Engineer

Blueroot Health INC.•Middletown, CT

just now•Onsite

About The Position

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.

Requirements

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

Responsibilities

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.
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.
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.
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.
Advise Product Development on ingredient selection, pre-launch formula definition, raw material variability mitigation, and commercial launch readiness.