Technical Quality Engineer

Developlus•Corona, CA

23h•Onsite

About The Position

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.

Requirements

Bachelor’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.

Nice To Haves

Bilingual English/Spanish is a plus.
Lean Manufacturing and/or Six Sigma certification is a plus.

Responsibilities

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.
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.
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.
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 real‑time technical support during trials, batching, scale‑ups, and troubleshooting events.
Support batch disposition decisions for trials and routine production.
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.
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.