**Technical Lead:**
We are seeking a highly skilled Technical Lead to oversee the implementation and maintenance of control systems in a medical device manufacturing environment. This role involves providing expert technical support and project management to ensure the smooth operation of all manufacturing operations and new product introductions.
Key Skills and Qualifications:
* Experience in a GMP regulated environment is essential.
* 3+ years experience in an automation engineering role, with software development of PLC/HMI/SCADA platforms in a GMP pharmaceutical industry environment.
* Strong experience with 21 CFR Part 11 requirements for automated systems in the pharmaceutical industry.
* Proven experience with plant start-ups and/or new product introductions to medical device facilities. Must be able to lead these activities in a start-up environment.
* Experience in qualification of control systems is essential.
* Experience in auditing and internal inspection would be advantageous.