Job Role Overview
We are seeking a highly skilled Compliance Automation Engineer to join our team. This is an exciting opportunity to work in the Biotech industry, supporting DMO compliance activities at a leading facility.
The successful candidate will be responsible for ensuring permanent inspection readiness within the DMO team and supporting the generation, review and approval of CSA deliverables.
Key Responsibilities:
* Ensure permanent inspection readiness within the DMO team.
* Support the generation, review and approval of CSA deliverables.
* Provide ongoing compliance coaching and support to all team members.
* Manage the deployment of Global SDLC/CSA and IT Security policies and procedures.
* Ensure the supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables.
Requirements:
At least 4 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
Degree qualification (Science, Engineering, Technical).
Preference for Lean Six Sigma Green Belt.
Desirable to have qualification in Project Management and Computer Validation.
Very Strong Collaboration, Compliance and Communication Skills.
A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
Experience in PLC/SCADA/DCS systems.