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CSV Engineer
Tandem Project Management Ltd.
Validate computerised and automated systems per GAMP5, 21 CFR Part 11, ensuring GMP compliance.
8d ago
Intermediate (4-7 years), Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Cork, County Cork, Ireland
Onsite
Company Size
50 Employees
Service Specialisms
Project Management
Construction Services
Consulting
Property Development
Engineering
Design
Turnkey
Sector Specialisms
Life Sciences
Commercial
Industrial
High Tech
Public
Role
What you would be doing
validation protocols
change control
gxp systems
data integrity
risk assessment
e‑validation tools
Our client, a leading biopharmaceutical company based in East Cork, is seeking a CSV Engineer to join their team. The successful candidate will support the validation of computerised and automated systems in compliance with GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements. This role will focus on preparing and executing validation documentation, supporting electronic validation system implementation, and collaborating with cross-functional teams to ensure systems are validated and maintained in accordance with GMP standards.
- Review and approve validation documentation to ensure compliance with site procedures and global validation standards.
- Collaborate with cross-functional teams including Quality, Automation, IT, and Manufacturing to ensure validation deliverables meet business and compliance objectives.
- Participate in system change control activities, including validation impact assessments and associated documentation.
- Prepare and execute validation deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ Protocols, and Validation Summary Reports for computerised and automated systems.
- Maintain validation documentation in alignment with data integrity principles (ALCOA+).
- Support the validation of GxP systems such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Production Information Management Systems (PIMS).
- Support deviation investigations and assist in defining and tracking CAPAs related to validated systems.
- Contribute to data integrity projects by performing risk and gap assessments, implementing remediation actions, and supporting audit trail review processes.
- Assist with the implementation and validation of electronic validation management tools.
- Promote continuous improvement by supporting the adoption of risk-based validation and Computer Software Assurance (CSA) approaches.
What you bring
bachelor’s
mes
lims
gamp 5
21 cfr
csv
- Bachelor’s Degree in Engineering, Computer Science, or a related technical discipline.
- Experience with the validation of systems such as MES, LIMS, or automation equipment software preferred.
- Working knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements.
- Minimum of 3 years’ experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biopharmaceutical environment.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
Company
Overview
- Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries.
- The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget.
- Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects.
- Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements.
- Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value.
- The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle.
- With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.
2017
Continuous Professional Development
The company has been accredited by Engineers Ireland for CPD since 2017, demonstrating a commitment to ongoing professional development and standards.
Repeat Business
Client Loyalty Track Record
The company maintains a strong track record of repeat business, reflecting its ability to consistently deliver exceptional results and build lasting partnerships.
- Safety and quality are at the heart of everything that we do.
- Openness, transparency and collaboration.
- Client‑centred, collaborative approach.
- Tailored approach to meet client needs.
- Driven by senior team who lead by example in professionalism and commitment.
- Lean techniques and value management methods to ensure fit‑for‑purpose outcomes and best value for money.
42% Reduction
Commitment to GHG Emissions
Targeting a significant reduction in greenhouse gas emissions as part of a science-based approach.
- Committed to 42% reduction in Greenhouse Gas emissions by 2030
- Established Carbon Action Team to measure, monitor and report GHG emissions annually to the Carbon Disclosure Project
- Initiatives include purchasing renewable energy, sourcing sustainably produced goods and services, monitoring and reducing waste
- Reducing paper usage, switching to electric company vehicles, ensuring efficient office utilities, seasonally adjusting temperature controls
Rating: 4.1/5
Equality, Diversity, and Inclusion
Based on Glassdoor reviews, the company has a strong rating for its commitment to Equality, Diversity, and Inclusion.
Rating: 3.8/5
Culture and Values
Glassdoor reviews highlight the company's overall Culture and Values, reflecting employee sentiment on workplace environment.
- Glassdoor reports ‘collaboration, respect, training, teamwork, autonomous working’ as pros
- Glassdoor reports ‘management are friendly and respectful’
- No public gender-split or DEI quantitative stats published
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