Quality Engineer II: Validation & NPI Process Lead

SGS Consulting; California City (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS Consulting is seeking a QA Validation Leader in California to guide new product development teams through validation planning, risk management, and documentation. You will author validation plans/reports and lead cross-functional PFMEAs to ensure regulatory readiness.

The role requires expertise in process/analytical method validation, cleaning validation, facility/utility qualification, and strong documentation discipline.

Qualifications

• Bachelor’s degree in science or engineering.
• 2+ years of validation experience.
• Experience with validation of analytical methods, cleaning, and facilities/utility qualifications.
• Familiar with CDRH/CBER and ISO regulations.
• Experience with change control documentation.
• Experience with electronic document management systems.
• Knowledge of statistics and SPC/acceptance sampling.
• Experience with risk analysis and PFMEA.
• Working knowledge of 21 CFR Part 11.

Responsibilities

• Provide Quality leadership to new product development teams in validation areas (validation planning, risk management, specification development).
• Author master validation plans and reports; author and execute validation protocols and reports (analytical methods, equipment, facilities/utilities, raw materials, process, cleaning).
• Review change controls and ensure completeness and impact of validation documents.
• Determine validation strategy based on risk-based approach and lead cross-functional PFMEA writing.
• Perform process risk assessments for non-conformance events and planned deviations.
• Assist in maintaining validation records and support NPI and sustaining projects.
• Review regulatory submissions/notifications under limited supervision and propose data-backed improvements.

Skills

Validation methods

Years experience

Process validation

Analytical method validation

Cleaning validation

Facilities qualification

Equipment qualification

Change control

Electronic document management

Statistics

PFMEA

Regulatory knowledge

21 CFR Part 11

CDRH/CBER ISO standards

Education

Bachelor’s degree in science or engineering

Job description

SGS Consulting is seeking a QA Validation Leader in California to guide new product development teams through validation planning, risk management, and documentation. You will author validation plans/reports and lead cross-functional PFMEAs to ensure regulatory readiness.

The role requires expertise in process/analytical method validation, cleaning validation, facility/utility qualification, and strong documentation discipline.