What are the responsibilities and job description for the GMP Compliance Expert position at SciPro?
Job Requirements
To be successful in this role, the ideal candidate will have a strong background in automation and control systems, including experience with building automation systems (BAS), enterprise management systems (EMS), and other automation and control system software, hardware, and associated interfaces.
The successful candidate will also have excellent technical skills, attention to detail, and the ability to work independently and collaborate effectively with cross-functional teams.
In addition, the Control Systems Technician will be responsible for handling day-to-day activities inclusive of life cycle management, issues, deviations, corrections, remediation, and improvement efforts of automation and controls systems for facility, equipment, systems, and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
Requirements:
- A minimum of a Bachelor's Degree in Science, Engineering, Automation, Information Technology, or equivalent technical discipline is required.
- A minimum of 2 years as an automation and controls field service technician. Experience troubleshooting complex systems is a must.
- Expertise in GMP compliance knowledge, including knowledge of 21 CFR Part 11, EU Annex 11, and other relevant regulations.
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Thorough knowledge and understanding of GMP data integrity standards.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products, as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
