Job Title: Technical Equipment Specialist
Description
We are seeking a skilled Technical Equipment Specialist to join our team. As a key member of our Operations group, you will be responsible for managing project deliverables and equipment qualification through technology transfer and commercialization in a new manufacturing facility.
Your primary focus will be on developing a deep understanding of the Manufacturing and Laboratory equipment being purchased and installed as part of the project. This includes planning, coordinating, and executing onsite validation activities such as Installation Qualification (IQ) and Operational Qualification (OQ).
You will work closely with cross-functional teams in monitoring project performance and provide weekly status updates on progress. You will also identify and develop risk-based approaches to change management in conjunction with validation and QA groups.
This is a critical role that requires strong technical skills and experience in medical device or similar industry. If you have a passion for delivering high-quality results and a proven track record of success, we encourage you to apply.
Key Responsibilities
* Develop a deep understanding of Manufacturing and Laboratory equipment
* Plan, coordinate, and execute onsite validation activities
* Work closely with cross-functional teams in monitoring project performance
* Provide weekly status updates on progress
* Identify and develop risk-based approaches to change management
Requirements
* Bachelor's degree in Chemical, Process, Mechanical, Automation Engineering, or related field
* Minimum 5-8 years of experience in medical device or similar industry
* Strong knowledge of regulations and applicable standards in Life Science industry
* Ability to manage and coordinate small teams of people