Senior QA Engineering Lead – GMP & Contamination Control

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 48,000 - 54,000; Full time

Job summary

Artech-Information-Systems-L.l.c. seeks a Quality Assurance Engineering Lead in Barceloneta, Puerto Rico, for a 12+ month engagement.

You will provide QA governance for global engineering programs spanning biologics, API, aseptic manufacturing, terminal sterilized products, medical devices, and labs, ensuring GMP compliance. Lead design reviews, risk assessments, and contamination control strategies; collaborate with client sites, cross-functional teams, and QA leaders to mitigate regulatory and

Qualifications

• Bachelor/master’s in engineering or Science related discipline with relevant experience in API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical device and QC/microbiology laboratories.
• 8+ years’ experience in pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Ability to manage multiple tasks and deliver on quality/GMP elements in a high urgency environment.
• Strong QA mindset with knowledge of biological/pharmaceutical technologies and regulatory expectations.

Responsibilities

• Provide QA governance and oversight for global engineering programs including biologics, API, aseptic manufacturing and labs.
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept to detailed design; mitigate identified risks.
• Lead contamination control risk assessments with cross-functional teams to ensure GMP compliance and contamination risk mitigation by design.
• Lead development of initial contamination control strategy for global engineering programs at Client Sites.
• Make key decisions on GMP and quality requirements for facility designs and communicate regulatory risks to the project risk register.
• Participate in system risk assessments and review qualification documents per risk-based qualification requirements.
• Collaborate with Client site quality team and cross-functional members to achieve quality deliverables.
• Understand aseptic manufacturing, terminal sterilization, API and biologics GMP requirements.

Skills

QA for C&Q facilities

Lab facility testing equipment

Contamination control risk assessments

Regulatory compliance (FDA/EMA)

Communication to senior QA leadership

Education

Bachelor/master’s in engineering or science

Job description

Artech-Information-Systems-L.l.c. seeks a Quality Assurance Engineering Lead in Barceloneta, Puerto Rico, for a 12+ month engagement.

You will provide QA governance for global engineering programs spanning biologics, API, aseptic manufacturing, terminal sterilized products, medical devices, and labs, ensuring GMP compliance. Lead design reviews, risk assessments, and contamination control strategies; collaborate with client sites, cross-functional teams, and QA leaders to mitigate regulatory and