Global QA Engineering Lead

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. in Barceloneta, Puerto Rico, seeks a Quality Assurance Engineering Lead to oversee global engineering programs ensuring GMP compliance and product quality.

As a primary QA representative, you will lead contamination control strategies, reviews of facility design, and risk assessments with cross-functional teams across sites. This role demands a strong engineering or scientific background, 8+ years in pharma QA/engineering, and excellent communication to keep

Qualifications

• Bachelor/Masters in Engineering, or Science related discipline with experience in API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical devices or QC/microbiology labs.
• 8+ years’ experience in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Ability to manage multiple tasks and deliver on quality/GMP elements while keeping the project on schedule.
• Knowledge of regulatory requirements and expectations for contamination control and GMP design.
• Knowledge of ISPE Baseline Guide Volume 5 and ICH Q9 for risk management and qualification.
• Self-directed, communicative, and able to work with key stakeholders in a fast-paced project environment.

Responsibilities

• Provide QA governance and oversight for global engineering programs including biologics, API, aseptic manufacturing, and medical devices.
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept to detailed design, ensuring mitigation of risks.
• Lead contamination control risk assessments with cross-functional teams to ensure GMP compliance and risk mitigation by design.
• Lead development of initial contamination control strategy for global programs at Sites.
• Make key GMP/quality decisions for facility, utility and equipment designs and report regulatory/compliance risks to the project lead.
• Participate in system risk assessments and review qualification documents in line with risk-based qualification requirements.
• Collaborate with site quality and cross-functional teams to deliver GMP/quality risk mitigation across programs.
• Apply knowledge of aseptic manufacturing, terminal sterilization, API and biologics GMP requirements.

Skills

Quality Assurance

GMP

Risk Management

Regulatory Compliance

Contamination Control

Cross-functional Leadership

Education

Bachelor/Masters in Engineering or Science

Job description

Validation & Engineering Group, Inc. in Barceloneta, Puerto Rico, seeks a Quality Assurance Engineering Lead to oversee global engineering programs ensuring GMP compliance and product quality.

As a primary QA representative, you will lead contamination control strategies, reviews of facility design, and risk assessments with cross-functional teams across sites. This role demands a strong engineering or scientific background, 8+ years in pharma QA/engineering, and excellent communication to keep