Job Description
Project Engineer - Equipment Validation
We are urgently seeking two Project Engineers with extensive experience in equipment validation, qualification, and commissioning, particularly, to provide immediate contract support. The role involves performing validation and qualification activities for packaging equipment, including blister units, cutting/scissor machines, tablet counters, and other packaging equipment. The engineers will also support on-boarding of new commercial clients and assist with serialization projects.
Key Responsibilities
- Lead and perform validation and qualification activities for packaging equipment, including blister units, cutting/scissor machines, and tablet counters, ensuring compliance with GMP and regulatory standards.
- Assist with packaging equipment validation and commissioning related to commercial product launches, ensuring equipment readiness in line with project timelines.
- Aid in onboarding new commercial clients, helping to integrate packaging systems and ensuring smooth project execution.
- Support serialization efforts, ensuring equipment and processes comply with regulatory and client requirements.
- Perform temperature mapping for over 100 freezers, coolers, and warehouse areas to ensure proper storage conditions per GMP standards.
- Prepare detailed validation protocols, reports, and other documentation, ensuring accuracy and regulatory compliance.
Requirements
- Minimum 5 years of experience in validation (IQ, OQ, PQ), qualification, and commissioning of packaging equipment in GMP-regulated facilities.
- Experience supporting commercial pharmaceutical product launches, especially in relation to packaging systems.
- Familiarity with packaging equipment such as blister units, cutting/scissor machines, and tablet counters. Experience with temperature mapping is highly preferred.
- Strong understanding of GMP standards and regulatory requirements for pharmaceutical packaging equipment.
- Ability to work independently, proactively resolving issues with minimal supervision.
- Excellent written and verbal communication skills to effectively collaborate with cross-functional teams and leadership.
