Quality Engineer II

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

Job Responsibilities

• Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
• Author master validation plans and reports.
• Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
• Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
• Determine validation strategy based on acceptable risk-based approach.
• Lead cross-functional team to write PFMEAs under limited supervision.
• Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
• Assist in maintaining validation records.
• Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
• Review regulatory submissions and/or notifications under limited supervision.
• Propose improvement projects with supporting data, flowcharts, etc.
• Assist in developing/updating departmental procedures and other controlled documents.
• Evaluate adequacy of specifications for new or modified process designs under limited supervision.
• Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
• Participate in process design reviews.
• Assist QE in Material Review Board (MRB) and Production Response Team (PRT) meetings.
• Participate in department process improvement’s goal(s).
• Assist in development, maintenance, and reporting of department metrics.
• Provides management with status updates on assigned responsibilities, goals and elevate issues in a timely fashion.

Skills

• Proficient in validation methods and evaluation criteria.
• 2+ years of experience
• Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications.
• Experience with change control process and documentation requirements.
• Experience with electronic document management systems.
• Understanding statistics, SPC and acceptance sampling.
• Experience with risk analysis and PFMEA.
• Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
• Working knowledge of 21 CFR Part 11.

Education/Experience

• Bachelor’s degree in science or engineering