Automation/Compliance Engineer
CR/080184
Posted: 10/12/2025
- Competitive Salary
- Ireland, County Meath, Dunboyne
- Contract
Orion Group Life Sciences are currently recruiting an Automation/Compliance Engineer (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Co. Meath on an initial 11-Month contract with potential to extend.
Responsibilities include:
• 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.
Experience, knowledge and skills:
• 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
Qualifications & Education:
• 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
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Responsibilities include:
• 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.
Experience, knowledge and skills:
• 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
Qualifications & Education:
• 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
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Beatriz Olmedo
Lead Recruitment Consultant
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