James Smithson

Quality Assurance Specialist/QP - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Quality Assurance Specialist/QP to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force.To ensure that products manufactured by the client are manufactured in accordance with the relevant GMPs.Responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product. What you’ll need: Third level qualification in a science discipline with extensive experience in the pharmaceutical industry.MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/ECExtensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.Extensive experience gained within an aseptic processing environment, ideally gained within a quality function. If this role is of interest, please apply now!#LI-JS4

QC Material Management Analyst - Ireland, Dublin - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a QC Material Management Analyst to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: Liaise with manufacturing to ensure all Drug Substance samples are processed and delivered to the appropriate destination in an appropriate timeframe.Liaise with Engineering Stores to ensure all Drug Product samples are processed and delivered to the appropriate destination in an appropriate timeframe.Liaise with Warehouse Cryogenics Logistics (WCL) to ensure all Raw Material samples are processed and delivered to the appropriate destination in an appropriate timeframe.Manage TempTales and shipping documents when receiving samples from external sites. What you’ll need: The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work in a team based collaborative environment.The ideal candidate should hold a minimum of a third level qualification (Degree) in Chemistry/Biology or related discipline.Extensive experience in a pharmaceutical / healthcare laboratory or related technical function. If this role is of interest, please apply now!#LI-JS4

Qualified Person - 12-months - IrelandOne of the top 10 best companies to work in Ireland is looking for a Qualified Person for their large-scale new facility in Ireland. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you'll do:  Review and approve QA/QP procedures, training materials, and Quality Agreements.Support start-up activities, including Manufacturer/Importation Authorisation submissions and knowledge transfer.Perform QP release of Investigational Medicinal Products (IMPs) in line with regulatory requirements.Provide guidance during Health Authority GMP/GDP inspections and audits.Advise stakeholders on quality issue management and process improvements.Maintain Site Master File and oversee Manufacturer/Importation Authorisation updates.Ensure rapid communication of significant quality issues to senior management.Review and approve procedural documents and participate in cross-functional teams.Influence external regulatory environment through interactions with authorities and industry groups.Identify risk areas and contribute to global audit planning.Supervise QA personnel and champion continuous improvement initiatives. What you'll need:  Degree in science, engineering, or related discipline.Extensive experience in biopharmaceutical/pharmaceutical industry quality roles.Eligibility to act as EU Qualified Person under Manufacturing/Importation Authorisation.Experience with QP release of IMPs (preferred) and Responsible Person on WDA (desirable).Strong knowledge of ICH/GMP, data integrity, regulatory guidelines, and clinical supply chain processes.Proven leadership and influence management skills in a global matrix environment.Excellent communication and stakeholder engagement skills.Commitment to fostering a culture of continuous improvement and compliance. If this role is of interest, please apply now!#LI-JS4

Project Engineer - Ireland - 12-months contract Our client is one of the world’s largest pharmaceutical organisations. With continued organisational growth including ongoing investment across the portfolio and capital projects programme at their manufacturing facility in Bray, an excellent opportunity has arisen for a Project Engineer to join the team. What you'll do:  Lead and execute medium to large-scale capital projects using structured project management methodologies.Deliver projects on time, within budget, and to the highest quality standards while managing risk.Coordinate and supervise all project activities through the full lifecycle—from initiation to handover.Manage cross-functional teams of internal and external specialists.Ensure compliance with PMM, cGMP, GEP, and organizational standards.Facilitate stakeholder engagement, problem-solving sessions, and alignment with business strategy.Oversee quality systems, EHS compliance, and readiness for inspections.Manage procurement, accounting compliance, and supplier relationships.Execute packaging-related projects such as blister line upgrades, NPI format parts procurement, and general asset care improvements. What you'll need:  Bachelor’s degree in engineering, science, or related technical field (engineering preferred).Extensive experience managing projects through the full lifecycle, including design, CapEx, procurement, scheduling, and CQV.Strong background in pharmaceutical or biotech environments and large company settings.Hands-on approach with experience supervising installation activities on-site.Expertise in project management methodologies and familiarity with GMP regulations.Strong financial acumen, strategic thinking, and stakeholder management skills.Ability to analyze and solve complex problems with innovative solutions.High awareness of Quality, EHS, and risk management standards.Certified Project Manager (IPMA or PMI) is a plus. If this role is of interest to you, please apply today! #LI-JS4

AIT LAB Systems Engineer - Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for AIT LAB Systems Engineer for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meets 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s, and Corporate & local compliance requirements.Support the introduction of new instrument systems.Work with all departments, QA, QC, CSV, NQC Engineering, and with contract vendors.Working with external laboratory suppliers to assist, configure and commission benchtop equipment. Take ownership of equipment in receiving deliveries and keeping track from delivery to commissioning. What you’ll need: Degree in Engineering, Information Systems, Computer Science or Life Sciences.Extensive experience of working in a pharmaceutical laboratory environment, with IT experience of laboratory instrument systems.Experience with Solovpe, FIT, Osm, Raman systems.Good working understanding of Windows file permissions, networking, Active Directory, Group Policies. If this role is of interest, please apply now!#LI-JS4

Senior Delta V Engineer - Ireland - 12-month contractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Senior Delta V Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: Design, code, and test DeltaV software changes throughout the project lifecycle.Work with a range of automation systems, including PLC and DCS platforms.Contribute to technical strategy for automated project execution.Review work during design, commissioning, and validation stages. What you’ll need: Extensive experience with DeltaV distributed control systems and Emerson Process Management platform.Strong knowledge of batch processing and S88 standards.Ideally trained through Emerson’s DeltaV training programs.Minimum 5 years’ experience in automation systems administration, with expertise in one or more: Rockwell FactoryTalk, DCS, OSI PI Historian, Syncade, Siemens.Excellent communication, organization, and planning skills.Proven problem-solving and project management ability.Ability to work independently and remotely with minimal supervision.Strong customer relationship management and critical thinking skills. If this role is of interest, please apply now!#LI-JS4

CQV Engineer HVAC - Ireland - 12-month contractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Develop and execute CQV testing documentation for HVAC and Clean Rooms in a sterile drug product facility.Manage project deliverables for safety, CQV schedule, and documentation quality.Ensure GMP Clean Rooms, Cold Rooms, and HVAC systems comply with GMP, company policies, and EU/FDA regulations.Commission and test non-GMP HVAC systems to project standards.Handle deviations and implement risk management plans for CQV activities.Perform FAT testing for assigned equipment.Coordinate with vendors and contractors during commissioning and qualification.Complete required training on time to meet site metrics. What you’ll need: BS degree in a scientific, technical, or engineering discipline.3–5 years’ pharmaceutical industry experience, ideally with sterile drug product filling line exposure.Proven ability to implement CQV strategies and execute testing from initiation to completion.End-to-end CQV lifecycle experience, from design through commissioning and handover.Strong understanding of project management processes: scope, design, implementation, and closeout.Experience delivering CQV projects safely, on time, and within budget as part of a diverse team.Hands-on CQV experience with sterile drug manufacturing HVAC and Clean Rooms, including automation systems.Familiarity with startup activities and safety protocols (LOTO, STW, PSSR).Solid background in documentation, execution, and task planning with a track record of timely delivery.Excellent communication and influencing skills.Experience working in matrix teams and using digital validation platforms (e.g., ValGenesis, Kneat).Innovative mindset with a focus on operational excellence and compliance with BMS policies and regulatory standards. If this role is of interest, please apply now!#LI-JS4

Project Engineer - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Project Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: To provide Engineering services to the plant, in order to maximise the availability of all Site Process Equipment and Utilities.To manage capital engineering projects within site following the Project Lifecycle approach (typical project value range: anything up to €5 million).To support the engineering teams in controlling uptime of process equipment and optimizing efficiencies both in equipment and process performance.To support the Engineering team with the emphasis on continual operational improvements. What you’ll need: Degree in a relevant Engineering Discipline (Mechanical/Chemical/Process)Extensive strong site experience in API Manufacturing / OSD Manufacturing / BioPharm but will consider more junior (3 years) if they have relevant project site experience.Proven track record in delivering Capital Projects – new equipment, utilities, facilities, etc.Good knowledge of change control and C&Q processes/execution. If this role is of interest, please apply now!#LI-JS4

Statistician - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Statistician for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Provide statistical support to Global Product Development & Supply (GPS) to deliver process and method robustness in ensuring product quality and compliance.Areas of support include statistical analysis for analytical methods, stability analysis, tech transfer, validation, manufacturing, health authority filings, and regulatory responses.Support in relation to study design and data analysis will be provided functions worldwide, including small molecule and biologics development, manufacturing, and supply.  What you’ll need: Masters in a STEM major with significant academic training in statistics and machine learning methodologies or a third level degree in statistics or data analytics.Extensive knowledge on statistical and machine learning methodologies, such as data distributions, regression, deep learning, and clustering. General knowledge of biologics/chemical engineering is a plus.Strong data analysis and programming skills. Proficient with major statistical software packages such as SAS, R, Python or JMP.Great communication, presentation, and technical writing skills. Ability to effectively communicate technical information in an understandable, rational, and concise manner. If this role is of interest, please apply now!#LI-JS4