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CSV Engineer
Tandem Project Management Ltd.
Lead MES EBR rollout and oversee computer system validation per GAMP5 standards.
8d ago
Intermediate (4-7 years), Experienced (8-12 years), Junior (1-3 years), Expert & Leadership (13+ 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
csv support
validation deliverables
documentation review
data integrity
change control
mes rollout
- Provide support and input into smaller CSV projects across the site.
- Plan, execute, and maintain validation deliverables in accordance with GAMP5 and site procedures.
- Collaborate with cross-functional teams, including Manufacturing, Automation, IT, and Quality, to ensure efficient and compliant validation project delivery.
- Prepare, review, and approve key documentation, including User Requirements Specifications (URS), Validation Plans, Test Protocols, and Summary Reports.
- Ensure all CSV activities are traceable and maintained in accordance with Data Integrity and site documentation practices.
- Participate in change control, deviation management, and periodic review processes related to computerised systems.
- Lead and support the rollout of MES Electronic Batch Records (EBR) in alignment with site validation strategies and cGMP requirements.
- Support the use of Kneat validation software for document lifecycle management.
What you bring
3+ years
engineering degree
csv
gamp5
21 cfr
mes
- Minimum of 3 years’ experience in a similar role and environment
- Degree in Engineering, Computer Science, or a related technical discipline.
- Proven experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical or biopharmaceutical environments.
- Comprehensive understanding of GAMP5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
- Strong working knowledge of MES systems and Electronic Batch Record (EBR) implementation.
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
People also searched
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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