Quality Engineer

Commissioning Partners LLC.; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

Commissioning Partners LLC is seeking a Quality Engineer to support quality systems, manufacturing operations, investigations, process improvements, and compliance within a regulated pharmaceutical environment.

The ideal candidate will have experience with deviation investigations, CAPA, change control, risk management, root-cause analysis, and continuous improvement while ensuring compliance with cGMP and company quality standards.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 3+ years in quality engineering or regulated manufacturing.
• Experience with deviations, CAPA, change control, RCA, and risk mgmt.
• Strong understanding of cGMP and pharma/biotech processes.
• Experience with root-cause methodologies (5-Why, Fishbone, FMEA).
• Strong technical writing and communication skills.

Responsibilities

• Support quality engineering activities for pharma, biotech operations.
• Investigate deviations, nonconformances, and quality events with RCA.
• Develop and monitor CAPA plans through completion.
• Support change controls and assess impact of changes.
• Review docs, batch records, SOPs, specs for compliance.
• Participate in internal, supplier, customer audits and inspections.
• Assist in SOPs, work instructions, and quality records.
• Monitor quality metrics and drive continuous improvement.

Skills

Quality engineering experience

Technical writing

Documentation

Communication

Problem-solving

Education

Bachelor's degree in Engineering or related field

Tools

TrackWise

Veeva

MasterControl

ETQ

Job description

We are seeking a Quality Engineer to support quality systems, manufacturing operations, investigations, process improvements, and compliance activities within a regulated pharmaceutical environment. The ideal candidate will have experience with deviation investigations, CAPA, change control, risk management, root-cause analysis, and continuous improvement while ensuring compliance with cGMP and company quality standards.

Key Responsibilities

• Support quality engineering activities for pharmaceutical, biotech, and regulated manufacturing operations.
• Investigate manufacturing deviations, nonconformances, complaints, and quality events using structured root-cause analysis methodologies.
• Develop and implement CAPA plans and monitor corrective and preventive actions through completion.
• Support change-control activities and assess the potential quality and compliance impact of proposed changes.
• Review manufacturing documentation, batch records, SOPs, specifications, procedures, and engineering documentation for compliance and accuracy.
• Support risk assessments, FMEA, process-risk analysis, and other quality risk-management activities.
• Partner with Manufacturing, Engineering, Validation, Maintenance, Automation, and Quality Assurance teams to resolve technical and quality issues.
• Analyze process and quality data to identify trends, recurring issues, process variation, and opportunities for improvement.
• Support investigations involving equipment failures, process deviations, environmental conditions, utilities, and manufacturing systems.
• Participate in internal audits, supplier audits, customer audits, and regulatory inspection readiness activities.
• Assist in developing and revising SOPs, work instructions, forms, specifications, and quality procedures.
• Review and approve technical documentation and quality records within the scope of assigned responsibilities.
• Support process and equipment qualification activities by reviewing protocols, test results, deviations, and qualification reports.
• Monitor quality metrics and support continuous-improvement initiatives focused on reducing deviations, improving reliability, and strengthening process controls.
• Ensure quality activities are performed in accordance with cGMP, FDA requirements, site procedures, and applicable quality standards.
• Maintain accurate and timely documentation of investigations, CAPAs, change controls, risk assessments, and quality activities.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3+ years of experience in quality engineering, manufacturing quality, validation, or a related role in a regulated industry.
• Experience with deviations, CAPA, change control, root-cause analysis, and quality risk management.
• Strong understanding of cGMP requirements and pharmaceutical/biotech manufacturing processes.
• Experience with investigation methodologies such as 5-Why, Fishbone, and FMEA.
• Ability to analyze technical and manufacturing data and identify process trends.
• Strong technical writing, documentation, communication, and problem-solving skills.

Preferred Qualifications

• Experience with FDA-regulated pharmaceutical or biotech manufacturing.
• Experience with TrackWise, Veeva, MasterControl, ETQ, or similar quality-management systems.
• Knowledge of process validation, equipment qualification, and computerized systems.
• Experience with Lean, Six Sigma, or continuous-improvement methodologies.
• ASQ certification or other relevant quality certification is a plus.