Job Title: Automation Engineer - Compliance Specialist
We are seeking an experienced Automation Engineer to join our team as a Compliance Specialist. The successful candidate will be responsible for ensuring that our manufacturing processes and systems meet the highest standards of quality, safety, and regulatory compliance.
Key Responsibilities:
* Support DMO Compliance activities at our biotech facility
* Ensure permanent inspection readiness within the DMO team
* Manage deployment of Global SDLC/CSA and IT Security policies and procedures
Requirements:
* Minimum 2 years experience in CSV activities in a biologic drug substance manufacturing plant
* Degree qualification (Science, Engineering, Technical)
* Preference for Lean Six Sigma Green Belt
* Strong knowledge of regulatory requirements associated with computer systems, including EU GMP Annex 11, 21 CFR Part 11
* Experience in PLC/SCADA/DCS systems
What We Offer:
* A dynamic and challenging work environment
* Opportunities for professional growth and development
* A competitive salary and benefits package
Please note that due to the expected high volume of applications, we can only reply to applicants suitable for the position.
Skills: Biologic CSV Scada