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Validation Engineer
Tandem Project Management Ltd.
Validate packaging systems/equipment ensuring regulatory compliance in biopharma
12d ago
Intermediate (4-7 years), Experienced (8-12 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
validation docs
deviation management
packaging validation
protocol development
equipment monitoring
team collaboration
- Generate and review validation documentation, including risk assessments, validation plans, summary reports, and SOPs.
- Manage deviations, CAPAs, and change controls related to packaging systems.
- Lead validation activities for packaging lines, serialization systems, labelling equipment, and related automation.
- Stay current with regulatory expectations, industry standards, and emerging technologies in packaging validation.
- Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Supply Chain) to ensure timely project delivery.
- Monitor equipment and process performance, driving improvements in reliability and compliance.
- Develop, execute, and maintain packaging validation protocols (IQ, OQ, PQ) in compliance with GMP, FDA, and EMA regulations.
- Support new product introductions by validating packaging configurations, artwork changes, and associated processes.
What you bring
3+ years
gmp
bachelor’s
packaging
regulatory
project management
- 3+ years’ experience in validation or engineering within a GMP-regulated environment (biopharmaceutical, pharmaceutical, or medical device).
- Proven ability to work independently and as part of a cross-functional team.
- Strong project management and communication skills.
- Bachelor’s degree in Engineering, Science, or related technical discipline.
- Strong knowledge of packaging operations (filling, labelling, serialization, tamper-evidence, etc.).
- Excellent documentation, analytical, and problem-solving skills.
- Familiarity with regulatory guidelines (FDA, EMA, Annex 15, ICH Q9/Q10).
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
Project Coordinator Jobs in Cork IrelandProject Engineer Jobs in Cork IrelandTesting Engineer Jobs in Cork IrelandControls Engineer Jobs in Cork IrelandAutomation Engineer Jobs in Cork IrelandQuality Engineer Jobs in Cork IrelandProcess Engineer Jobs in Cork IrelandQuality Control Jobs in Cork Ireland
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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