Technical Quality Engineer

Technical Quality Engineer ScaleUp & Cleaning Validation Department: Quality Assurance
Reports To: Quality Manager / Quality Engineering Supervisor
Location: Corona, CA Magnolia Facility FUNCTION The Technical Quality Engineer ScaleUp & Cleaning Validation serves as the Quality Assurance owner for manufacturing readiness, batch scaleup quality, process consistency, and contamination control within the organization. This role ensures that formulations developed by R&D are transferred into pilot and fullscale manufacturing through controlled, repeatable, and compliant processes that protect product quality, batch integrity, and operational performance. Reporting within Quality Assurance and working crossfunctionally 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 batchtobatch variation, strengthening process capability, supporting scaleup success, and improving plantside 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 ScaleUp

• Serve as Quality Assurance lead for formulation transfer from R&D into pilot and fullscale manufacturing.
• Support and oversee batch scaleups to ensure processes are robust, repeatable, and compliant.
• Define, verify, and support implementation of CQAs and CPPs during scaleup, trials, and routine production.
• Partner with R&D to translate laboratory formulations and test methods into productionready 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 batchtobatch 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, scaleups, and new product introductions.
• Investigate cleaning and sanitationrelated 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 testing techniques, sampling plans, quality dispositions, and acceptance criteria are clearly defined and consistently applied.
• Provide realtime technical support during trials, batching, scaleups, and troubleshooting events.
• Support batch disposition decisions for trials and routine production.

Training & Coaching

• Train, coach, and mentor Quality Control and Laboratory Technicians on testing methods, GMP expectations, data interpretation, and quality standards.
• Support onboarding and technical development of new laboratory personnel.
• Assist with development and revision of training materials, test methods, and quality work instructions.

Documentation & Compliance

• Ensure batch records, testing results, cleaning documentation, and quality records are completed accurately and in compliance with GMP and internal quality systems.
• Support internal audits, inspections, and overall regulatory readiness.
• Assist in issuance of Certificates of Analysis (CoA) and Certificates of Conformance (CoC), as required.

REQUIREMENTS Education & Experience

• Bachelors degree in Chemistry, Chemical Engineering, Quality Engineering, or a related technical field, or an equivalent combination of education and experience.
• Experience supporting batch manufacturing, compounding, or formulationbased production environments.
• GMP experience required; quality auditing experience preferred.
• Knowledge of ISO 9001, GMP, or equivalent quality management systems.
• Proficient in Microsoft Office applications and experience with ERP systems.
• Bilingual English/Spanish is a plus.
• Lean Manufacturing and/or Six Sigma certification is a plus.

Physical Demands: While performing the duties of this job, the employee is regularly required to wear PPE, talk and hear. This position requires little repetitive hand movements, walking, filling, and standing for long periods of time, bending, occasionally lifting 25-50 lbs. and filing throughout the workday. Additionally, it may require working in rapidly hot and cold environments. Specific vision abilities required by this job include close vision and the ability to work in front of a computer monitor for extended periods of time.