As a Principal Equipment Management Specialist, you will lead the successful execution of equipment introduction and qualification within the analytical workstream. Key responsibilities include managing teams, ensuring regulatory compliance, and collaborating with vendors to deliver projects on time. This role requires strong leadership skills, excellent communication, and problem-solving abilities.
Key Responsibilities
* Manage equipment introduction and qualification processes
* Ensure compliance with EudraLex GMP guidelines and other regulatory requirements
* Collaborate with internal and external stakeholders, including Quality Assurance, Regulatory Affairs, and analytical personnel
* Develop and implement standard operating procedures and detailed specifications
* Perform validation and calibration activities, and manage instrument and equipment schedules
* Liaise with vendors and Calibration, EHS, QA, and QC teams to deliver project schedules
Requirements and Qualifications
* 4+ years' experience in a fast-paced environment, preferably in a GMP facility or pharma/biopharma FDA-regulated environment
* Strong computer skills, particularly in MS Office (Word, Excel, PowerPoint)
* Excellent planning, organizational, communication, and interpersonal skills
* Diploma/degree qualification desirable