Purpose:
The Compliance Engineer will be responsible for supporting DMO Compliance activities at the single use multi-product biotech facility.
Responsibilities
* Ensure permanent inspection readiness within the DMO team.
* Support generation/review/approval of CSA deliverables.
* Providing ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members.
* Manage deployment of Global SDLC/CSA and IT Security policies and procedures.
* Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc.
* Ensure highest Quality, EHS & Compliance standards.
* Active participation in the Tier process and proactively resolving issues.
* Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives.
* Coordinate AIT Change-controls, EHS activities and EHS/Quality metrics
* Completion of AIT Investigations, root-cause analysis and CAPA's
* Strong project management skills to support project delivery and operational readiness.
* At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
* 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
Requirements
* 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
Desired Skills and Experience
2+ years CSV experience in biologics manufacturing
Knowledge of EU GMP Annex 11, 21 CFR Part 11, Data Integrity
Experience with PLC/SCADA/DCS systems
Degree in Science/Engineering
Strong project & compliance management skills