NovintiX is seeking an experienced Project Engineer with strong expertise in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within a regulated medical device (MedTech) manufacturing environment.
The successful candidate will support new equipment introduction, process validation, and continuous improvement projects ensuring compliance with GMP, ISO *****, and FDA requirements.
Key Responsibilities: Lead and execute equipment installation, commissioning, and validation (IQ/OQ/PQ) activities.
Prepare and review validation protocols, reports, and related documentation in line with regulatory and quality standards.
Manage capital equipment and automation project deliverables, ensuring alignment with production and quality objectives.
Collaborate with manufacturing, quality, maintenance, and automation teams during project execution.
Conduct risk assessments (FMEA) and ensure equipment meets safety and compliance requirements.
Support change control, CAPA, and deviation investigations related to equipment and process validation.
Ensure validation documentation meets audit-readiness standards for FDA, ISO, and internal audits.
Participate in process improvement and cost reduction initiatives across manufacturing operations.
Track project timelines, resources, and budgets while maintaining quality and compliance.
Required Skills & Experience: Bachelors degree in Mechanical / Electrical / Automation / Biomedical / Manufacturing Engineering or related discipline.
4+ years of experience in equipment or process validation within the medical device, pharma, or biotech industry.
Proven expertise in IQ, OQ, PQ and validation lifecycle management.
Skills: IQ OQ PQ Project Management Manufacturing equipment installation validation protocols