Quality Engineer II

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

Job summary

SGS Consulting in Sacramento seeks a Quality Validation Lead to guide new product development teams through validation, risk management, and specification development.

You will author master validation plans and reports, execute protocols for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning, and review change controls to ensure compliance with regulatory standards.

Qualifications

• Bachelor’s degree in science or engineering
• 2+ years of experience in validation and related activities
• Experience with regulatory compliance and documentation requirements
• Experience with electronic document management systems

Responsibilities

• Provide quality leadership to new product development teams in 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 escape issues in a timely fashion.

Skills

Validation methods

Evaluation criteria

Process validation

Analytical method validation

Cleaning validation

Facility qualifications

Equipment qualifications

Change control

Electronic document management

Statistics / SPC

PFMEA

Regulatory knowledge (21 CFR Part 820;

21 CFR Part 11

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 escape issues in a timely fashion.

Skills

• Proficient in validation methods and evaluation criteria.
• 2+ years of experienceExperience 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