Technical Quality Engineer

Position Title:

Technical Quality Engineer - Scale‑Up & Cleaning Validation

Department:
Quality Assurance

Reports To:

Quality Manager / Quality Engineering Supervisor

Location:

Corona, CA - Magnolia Facility

FUNCTION

The Technical Quality Engineer - Scale‑Up & Cleaning Validation serves as the Quality Assurance owner for manufacturing readiness, batch scale‑up quality, process consistency, and contamination control within the organization. This role ensures that formulations developed by R&D are transferred into pilot and full‑scale manufacturing through controlled, repeatable, and compliant processes that protect product quality, batch integrity, and operational performance.

Reporting within Quality Assurance and working cross‑functionally with R&D, Production, Quality Control, and Operations, this position leads quality engineering activities required to define, implement, monitor, and continuously improve critical quality attributes (CQAs), critical process parameters (CPPs), testing methods, and process controls associated with compounding and batch execution. The role is responsible for reducing batch‑to‑batch variation, strengthening process capability, supporting scale‑up success, and improving plant‑side execution during trials, startups, and routine production.

This position also owns the technical evaluation, verification, and continuous improvement of cleaning and sanitation processes for compounding, batching, equipment changeovers, and laboratory operations to ensure effective contamination control and scientifically sound cleaning verification practices. In addition, the Technical Quality Engineer provides technical training, coaching, and quality support to Quality Control and Laboratory personnel and serves as a key quality partner in building standardized, scalable manufacturing systems that support growth, operational reliability, and successful commercialization.

ESSENTIAL DUTIES AND

KEY RESPONSIBILITIES

Manufacturing Readiness & Batch Scale‑Up

* Serve as Quality Assurance lead for formulation transfer from R&D into pilot and full‑scale manufacturing.

* Support and oversee batch scale‑ups to ensure processes are robust, repeatable, and compliant.

* Define, verify, and support implementation of CQAs and CPPs during scale‑up, trials, and routine production.

* Partner with R&D to translate laboratory formulations and test methods into production‑ready specifications and procedures.

* Provide quality oversight during batching, startups, and production runs to ensure adherence to specifications and batch integrity requirements.

Process Control, Capability & Variation Reduction

* Identify sources of batch‑to‑batch variation and recommend process controls, testing improvements, and system enhancements.

* Analyze qualitative and quantitative data, including SPC trends, deviations, and investigations.

* Lead and support root cause analysis, CAPA development, and effectiveness verification.

* Participate in FMEA activities, risk assessments, and process qualifications.

* Support continuous improvement initiatives focused on yield, consistency, quality performance, and process capability.

Cleaning Validation & Sanitation Process Ownership

* Own the evaluation, verification, and continuous improvement of cleaning and sanitation processes associated with compounding, batching, changeovers, and laboratory operations.

* Ensure cleaning procedures, techniques, frequencies, and acceptance criteria are appropriate, effective, and scientifically justified.

* Establish, assess, and verify cleaning effectiveness and verification testing methods (e.g., visual inspection, analytical testing, rinse testing, residue limits).

* Support cleaning validation activities and risk assessments related to formulation changes, scale‑ups, and new product introductions.

* Investigate cleaning‑ and sanitation‑related deviations and drive corrective and preventive actions.

* Support development, maintenance, and training of SOPs and work instructions related to cleaning and sanitation practices.

Quality Liaison & Technical Support

* Act as the technical Quality Assurance liaison between R&D, Production, and Quality Control.

* Ensure proper…