Technical Quality Engineer

Developlus

Corona, CA

JOB DETAILS
SKILLS
Analysis Skills, Auditing, Certificate Issuance, Chemical Engineering, Chemistry, Coaching, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Delivery Driving, Documentation, ERP (Enterprise Resource Planning), English Language, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), Genetics, Hair Coloring, ISO 9001, Internal Audit, Laboratory Equipment, Laboratory Management, Laboratory Operations, Laboratory Testing, Lean Manufacturing, Lean Six Sigma, Lift/Move 25 Pounds, Lift/Move 50 Pounds, Maintain Compliance, Manufacturing, Manufacturing Systems, Materials Testing, Medical Conditions, Mentoring, Microsoft Office, Multilingual, Onboarding, Operational Support, Operations Management, Performance Analysis, Physical Demands, Process Capability, Process Control Engineering, Product/Service Launch, Production Control, Production Specifications, Production Systems, Qualitative Analysis, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Engineering, Quality Management, Quality Metrics, Quantitative Analysis, Record Keeping, Regulations, Research & Development (R&D), Risk Analysis, Root Cause Analysis, Sanitation, Scalable System Development, Six Sigma Certification, Spanish Language, Staff Development, Standard Operating Procedures (SOP), Startup, Systems Analysis, Systems Scalability, Team Player, Technical Analysis, Technical Support, Technical Training, Testing
LOCATION
Corona, CA
POSTED
2 days ago

Developlus is an Equal Employment Opportunity Employer. We take pride in the family‑oriented, collaborative company culture we have created. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, or any other characteristic protected by law. Browse our openings below to find a position that suits your skills:Position: Technical Quality EngineerLocation: Corona, CAJob Id: 348Position Title: Technical Quality Engineer – Scale‑Up & Cleaning ValidationDepartment: Quality AssuranceReports To: Quality Manager / Quality Engineering SupervisorLocation: Corona, CA – Magnolia FacilityFUNCTIONThe 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 RESPONSIBILITIESManufacturing Readiness & Batch Scale‑UpServe 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 ReductionIdentify 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 OwnershipOwn 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 SupportAct 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 real‑time technical support during trials, batching, scale‑ups, and troubleshooting events.Support batch disposition decisions for trials and routine production.Training & CoachingTrain, 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 & ComplianceEnsure 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.REQUIREMENTSEducation & ExperienceBachelor's 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 formulation‑based 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.Developlus is proud to manufacture innovative hair color with a conscience for consumers and professionals.#J-18808-Ljbffr

About the Company

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Developlus