Lab CQV Engineer

Arcadis; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Arcadis is seeking a Lab CQV Engineer to support laboratory equipment projects across Drug Substance, Vaccines, Bioprocessing and Parenteral units. You will provide engineering SME expertise to ensure IQ/OQ/PQ, commissioning and qualification meet local and regulatory requirements.

The role focuses on bench-top and analytical lab equipment, Nova BioProfile FLEX systems, and collaborates with Quality, Automation, IT and equipment vendors to deliver compliant solutions.

Qualifications

• B.Sc./B.Eng. in engineering, science or related field.
• 2-5 years GMP bioprocess or regulated lab experience.
• Experience delivering CQV across lifecycle.
• Knowledge of GMP, data integrity, change control and risk-based qualification.

Responsibilities

• Lead or support laboratory equipment CQV projects across the lifecycle.
• Develop, review and execute IQ/OQ/PQ protocols and qualification reports.
• Coordinate vendor activities for installation, calibration and commissioning.
• Ensure compliance with GMP and regulatory requirements.
• Maintain validated state through calibration and maintenance reviews.
• Collaborate with Engineering, Quality, Automation, IT and vendors.

Skills

CQV experience

GMP knowledge

Cross-functional teamwork

Documentation skills

Communication skills

Risk-based qualification

Education

B.Sc./B.Eng. in engineering or science

Tools

Nova BioProfile FLEX

Laboratory equipment CQV

Job description

Whether you are involved in the design and development of manufacturing processes for products, or supporting maintenance and reliability, engineering is vital in making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with dynamic projects and engineering teams, the Lab CQV Engineer will support laboratory equipment projects across the Drug Substance, Vaccines, Bioprocessing and Parenteral Operating Units throughout the project lifecycle. The job holder will provide engineering and technical SME expertise to ensure laboratory instruments and associated systems are specified, designed, installed, commissioned and qualified to local and regulatory requirements. Reporting to the Equipment Technology Lead or Team Manager, this role will support sustaining activities and key projects as required. The role will have a particular focus on bench-top and small laboratory equipment, including Nova BioProfile FLEX systems or equivalent cell culture analysers, together with other analytical, mobile and laboratory support equipment. As a Lab CQV Engineer, your knowledge and skills will contribute towards the goals and objectives of the team. Your ability to meet team targets will help complete critical deliverables, while effective communication will support alignment between laboratory users, Engineering, Quality, Automation, IT and equipment vendors. It is your hard work and focus that will make the company ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of Laboratory Equipment CQV projects, manage your own time to meet agreed targets and develop plans for short-term work activities on your own projects.
• Lead or support the qualification of bench-top, mobile and analytical laboratory equipment, including cell culture analysers such as Nova BioProfile FLEX systems, balances, centrifuges, incubators, biosafety cabinets, freezers, refrigerators, pH and conductivity meters and other laboratory instruments.
• Develop, review and execute lifecycle documentation including user requirements, risk assessments, design and vendor documentation reviews, commissioning tests, IQ/OQ/PQ protocols, traceability matrices and qualification summary reports.
• Assess equipment software, interfaces, user access, audit trails, data handling and connectivity requirements with Quality, Automation, IT and laboratory stakeholders, where applicable.
• Coordinate vendor activities, installation, calibration and commissioning, and leverage appropriately documented vendor testing into the site qualification approach.
• Implement changes to laboratory equipment and associated systems under site change management and change control processes as part of sustaining and capital projects.
• Maintain the validated state of laboratory equipment through periodic review, calibration and maintenance impact assessment, controlled changes and timely investigation of deviations.
• Participate in the development and maintenance of laboratory equipment lifecycle documents, procedures and equipment records.
• Ensure that work performed is accurate, timely, efficient and compliant with corporate policies, Good Manufacturing Practice regulations and Regulatory Agency requirements.
• Support risk assessments, deviation investigations, corrective actions and qualification issue resolution for assigned equipment.
• Be solutions orientated, delivery focused and passionate about providing practical technical support to laboratory and manufacturing teams.
• Adhere to all elements of the IIF safety programme during all phases of the project lifecycle.
• Undertake any other activities as directed by the Area Lead.

Qualifications/Skills Must-Have

• B.Sc./B.Eng. in an engineering, science or related technical discipline, or equivalent experience.
• 2-5 years’ experience in a Good Manufacturing Practice environment within bioprocess, pharmaceutical manufacturing or a regulated laboratory setting.
• Experience delivering laboratory equipment CQV projects across the lifecycle, including specification, design review, installation, commissioning, qualification and validation maintenance.
• Demonstrated experience generating and executing commissioning and qualification test plans and protocols.
• Working knowledge of GMP, data integrity, change control, deviation management and risk-based qualification principles.
• Ability to provide practical technical solutions for complex equipment and compliance issues.
• Proven ability to work in cross-functional teams with strong communication, coordination and interpersonal skills.
• Strong documentation skills and the ability to manage multiple equipment work packages and agreed priorities.

Nice-to-Have

• Hands-on CQV experience with Nova BioProfile FLEX or similar cell culture analysers and bench-top analytical equipment.
• Experience with incubators, biosafety cabinets, balances, centrifuges, refrigerators, freezers, pH/conductivity meters, osmometers, spectrophotometers or other laboratory instruments.
• Experience assessing computerised laboratory equipment, software configuration, access control, audit trails, electronic records and interfaces.
• Experience with temperature mapping and controlled-temperature laboratory equipment.
• Experience using electronic validation tools.
• Experience presenting CQV packages to internal and external auditors.
• Relevant site knowledge and experience working across Drug Substance, Vaccines, Bioprocessing, Parenteral or laboratory operations.

Organisational Relationships:

It is anticipated that the holder of this role will interact regularly with laboratory users and cross functional groups site-wide, including Engineering, Quality, Validation, Automation, IT, Operations, Maintenance, Calibration and equipment vendors.