My client is seeking a skilled Project Engineer to lead and support technical projects within a highly regulated manufacturing environment, focusing on medical devices, pharmaceuticals, or biotech. This role requires managing resources, schedules, and quality standards to ensure adherence to regulatory and industry standards throughout the product development lifecycle.
Responsibilities:
- Process Optimization: Develop, configure, and enhance processes from initial development through to start-up and validation, ensuring efficiency and scalability.
- Regulatory Compliance: Maintain strict adherence to Quality Management System (QMS) protocols and industry standards, including FDA, GMP, and ISO 13485 compliance, to meet regulatory requirements.
- Project Management: Oversee the creation and execution of project plans, design strategies, and validation processes, tracking deliverables against timeline and budget.
- Vendor Coordination: Collaborate with external suppliers and vendors to manage project risks, track progress, and ensure timely delivery, aligning with overall program goals.
- Technical Support: Provide engineering support to manufacturing teams, enhancing production yields, quality consistency, and equipment validation.
Qualifications:
- Educational Background: Bachelor’s degree in Engineering (Mechanical, Electrical, or Biomedical preferred).
- Experience: 5+ years in regulated manufacturing or process development, ideally with exposure to medical device or pharma product validation, including packaging and serialization.
- Technical Skills: Proficiency in MS Office and statistical analysis tools (e.g., Minitab), with experience in IQ, OQ, PQ processes.
- Core Competencies: Strong technical writing, analytical skills, and ability to manage complex projects while ensuring cross-functional collaboration.
If the above position sounds like something you would be interested in, please APPLY NOW. Also, please share with your own network if you think it could be good for someone you know!
