Matrix Recruitment are currently recruiting for a Compliance / Automation Engineer on behalf of our client based in Meath.
What you need to know:
Hybrid role, days only, no shift.
Your New Job:
The Compliance Engineer will be responsible for supporting DMO Compliance activities at the single use multi-product biotech facility.
Key Duties and 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.
What are we looking for?
Minimum 2 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.
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.
Apply for this job now or get in touch with Brenda on 087-4343544.
By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.
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