Jt001 - Sr Quality Specialist/Engineer

Quality Consulting Group • Juncos, PR

2d

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Supports the manufacturing operations by ensuring compliance of computerized systems and manufacturing equipment integrations with regulatory and quality standards. Focuses on Computer System Validation (CSV), quality system compliance, and IT integration within manufacturing environments to maintain operational excellence and regulatory compliance. Support Computer System Validation (CSV) activities for manufacturing and quality systems in compliance with regulatory requirements. Ensure integration of IT systems with manufacturing equipment operates within validated and compliant frameworks. Develop, execute, and review validation protocols (IQ, OQ, PQ) and associated documentation. Maintain compliance with Quality Systems Regulations (QSR), GMP, and internal quality procedures . Participate in risk assessments, change control activities, and deviation investigations related to computerized systems. Collaborate with IT, Manufacturing, Engineering, and Quality teams to ensure proper implementation and validation of system integrations. Support audit readiness and regulatory inspections by maintaining accurate validation and quality documentation. Identify opportunities to improve system reliability, data integrity, and process efficiency . Qualifications: Bachelor's degree in engineering Experience with IT systems integrated with manufacturing equipment . Knowledge and hands-on experience in Computer System Validation (CSV) . Experience working within regulated quality systems and compliance environments . Understanding of GxP, data integrity, and validation lifecycle processes . Strong problem-solving and analytical skills . Computer Systems Validation (CSV) Manufacturing Systems Integration Quality Systems Compliance (GMP / QSR) Validation Documentation (IQ / OQ / PQ) Change Control and Deviation Management Risk Assessment and Data Integrity Controls Experience in medical device manufacturing environments . Knowledge of automated manufacturing equipment and data systems . Familiarity with FDA regulations and validation standards (21 CFR Part 11, GAMP 5) Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Requirements

• Bachelor's degree in engineering
• Experience with IT systems integrated with manufacturing equipment
• Knowledge and hands-on experience in Computer System Validation (CSV)
• Experience working within regulated quality systems and compliance environments
• Understanding of GxP, data integrity, and validation lifecycle processes
• Strong problem-solving and analytical skills
• Computer Systems Validation (CSV)
• Manufacturing Systems Integration
• Quality Systems Compliance (GMP / QSR)
• Validation Documentation (IQ / OQ / PQ)
• Change Control and Deviation Management
• Risk Assessment and Data Integrity Controls
• Experience in medical device manufacturing environments
• Knowledge of automated manufacturing equipment and data systems
• Familiarity with FDA regulations and validation standards (21 CFR Part 11, GAMP 5)

Responsibilities

• Supports the manufacturing operations by ensuring compliance of computerized systems and manufacturing equipment integrations with regulatory and quality standards.
• Focuses on Computer System Validation (CSV), quality system compliance, and IT integration within manufacturing environments to maintain operational excellence and regulatory compliance.
• Support Computer System Validation (CSV) activities for manufacturing and quality systems in compliance with regulatory requirements.
• Ensure integration of IT systems with manufacturing equipment operates within validated and compliant frameworks.
• Develop, execute, and review validation protocols (IQ, OQ, PQ) and associated documentation.
• Maintain compliance with Quality Systems Regulations (QSR), GMP, and internal quality procedures .
• Participate in risk assessments, change control activities, and deviation investigations related to computerized systems.
• Collaborate with IT, Manufacturing, Engineering, and Quality teams to ensure proper implementation and validation of system integrations.
• Support audit readiness and regulatory inspections by maintaining accurate validation and quality documentation.
• Identify opportunities to improve system reliability, data integrity, and process efficiency

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level