Global QA Engineering Lead

Pinnaql, Inc.; Barceloneta (PR); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group, Inc. seeks a Quality Assurance Engineering Lead to drive QA oversight across global engineering programs, including biologics, API and aseptic manufacturing.

You will collaborate with site and cross-functional teams to uphold GMP requirements, lead contamination control strategies, and guide design reviews from concept through detail phases, ensuring regulatory compliance and timely delivery.

Formación

• 8+ years in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Bachelor/Masters in Engineering, or Science related discipline.
• Strong ability to manage multiple tasks and deliver on quality/GMP elements.
• Knowledge of FDA/EMEA regulations and contamination control.
• Experience with ISPE Baseline Guide Volume 5 and ICH Q9.
• Self-directed, motivated, able to represent QA in a fast-paced project environment.
• Excellent communication skills, both written and verbal.

Responsabilidades

• Provide QA governance and oversight for global engineering programs (biologics, API, aseptic manufacturing, MDR and labs).
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept to detail design, mitigating risks.
• Lead contamination control risk assessments with cross-functional teams to ensure GMP compliance.
• Develop initial contamination control strategy for global programs at sites.
• Decide GMP and quality requirements for designs and report regulatory/quality risks to the project risk register.
• Participate in SRAs and review qualification documents per risk-based qualification requirements.
• Collaborate with site quality and cross-functional teams to achieve GMP deliverables.
• Maintain knowledge of aseptic manufacturing, terminal sterilization, API and biologics GMP requirements.
• Stay informed on FDA/EMEA/regional health authority expectations.
• Apply Quality Risk Management and ISPE/ICH guidelines.

Conocimientos

Quality Assurance

Engineering

GMP

Regulatory compliance

Risk management

Biologics

Aseptic manufacturing

Project management

Communication skills

Educación

Bachelor's or Master's in Engineering/Science

Descripción del empleo

Validation & Engineering Group, Inc. seeks a Quality Assurance Engineering Lead to drive QA oversight across global engineering programs, including biologics, API and aseptic manufacturing.

You will collaborate with site and cross-functional teams to uphold GMP requirements, lead contamination control strategies, and guide design reviews from concept through detail phases, ensuring regulatory compliance and timely delivery.