Statistician

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

Construction Logistics Manager - Germany, Alzey - 12 Months Inital Contract Are you a Construction Logistics Manager looking for your next contract role? We have a fantastic opportunity for you to join our valued client in Alzey on an initial 12 month contract. Experienced at delivering highly efficient projects for state-of-the-art Data Centres, Pharma, Semi- Conductor infrastructures around the world, our client is a global leader in design, engineering and delivery of facilities for high tech industries. This is your chance to join an innovative, market leading data centre company as their newest Construction Logistics Manager. With growth plans to almost double their already huge turnover, there could not be a better time to join! What you'll do: Develop and implement a comprehensive logistics strategy tailored to a pharmaceutical construction environment.Coordinate the movement and installation of site cabins, welfare units, and canteens, ensuring minimal disruption to operations.Manage mission-critical logistics operations, ensuring continuity of essential services and compliance with GMP standards.Oversee material deliveries, including scheduling, offloading, storage, and distribution across the site. What you'll need: Proven experience in construction logistics management on pharmaceutical or other regulated industrial sites.Demonstrated ability to manage mission-critical logistics in high-compliance environments.Strong background in site setup and movement of temporary structures (cabins, canteens, etc.).Experience in delivery coordination, traffic management, and material handling. If this role is of interest to you, please apply now! #LI-CL2

QA Clinical Specialist - UK, Slough - 12 Month ContractWe are looking for an experienced QA Clinical Specialist for a fantastic 12 month contract based in Slough. You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease. This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first. What you'll do: Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s).Participate in Audit and Inspection planning with Global Quality.Represent or ensure GCSO representation including preparation during audits/inspections (on-site at UCB by internal and external parties). What you'll need: Extensive pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections.Extensive experience in SOP writing essential. If this role is of interest to you, please apply now! #LI-KT1

Technical Services Engineer (Equipment & Projects) - Galway - 12 Months Initial Contract Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a Technical Service Engineer to join their team in their existing manufacturing facility in Galway. The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Technical Services Engineer to help maintain manufacturing operations.What you'll do: Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.Experience with validation lifecycle approach (URS, FAT/SAT, PQ).Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV). What you'll need: Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.Experience with validation lifecycle approach (URS, FAT/SAT, PQ).Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV). If this role is of interest to you, please apply now! #LI-AE1

Technical Services Engineer (Product/Process) - Galway - 12 Month ContractAre you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a Technical Services Engineer to join their team in their existing manufacturing facility in Galway. The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Technical Services Engineer to help maintain manufacturing operations.What you'll do: Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.Experience with process validation (PPQ), DOE, and statistical process control (SPC).Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc. What you'll need: Extensive experience in pharmaceutical manufacturing or process engineering, with experience in sterile injectables or biologics.Strong working knowledge of aseptic processing, including lyophilization, terminal sterilization, and isolator-based filling operations.Hands-on experience with process validation (PPQ, CPV), risk assessments (FMEA), and root cause analysis.Proficiency in regulatory compliance: cGMP, Annex 1, FDA, EMA, and ICH guidelines. If this role is of interest to you, please apply now! #LI-AE1

Quality Engineer - Galway - Permanent ContractAre you a Quality Engineer looking for your next pharmaceutical role? Our client is a global medical technology leader dedicated to transforming lives through innovative medical solutions. With a history spanning decades, the company has established itself as a pioneer in the industry, serving millions of patients worldwide. Through continuous research and development, our client has introduced groundbreaking products across various medical specialties, including cardiology, neurology, and urology.What you'll do: Identifies and resolves complex exceptions to work assignments.Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.Participates in Customer Complaints investigation for areas under their control. What you'll need: A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.Extensive experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.Familiar with Internal Audit Processes.Team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives. If this role is of interest, please apply now. #LI-JS4

Process Engineer (Drug Product) - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Process 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: Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.Monitoring and analysis of process data during the manufacturing.Assisting in the development of the manufacturing process for new products.Providing operational technical support for process related issue resolution. What you’ll need: Third level degree in a relevant engineering, science or technical discipline required.Masters Qualification in relevant technical discipline desirable.Extensive experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.Experience in new product introductions to Biologic facilities desirable. If this role is of interest, please apply now!#LI-JS4

Single Use Process Scientist - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Single Use Process Scientist 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: Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.Monitoring and analysis of process data during the manufacturing.Assisting in the development of the manufacturing process for new products.Providing operational technical support for process related issue resolution. What you’ll need: Third level degree in a relevant engineering, science or technical discipline required.Masters Qualification in relevant technical discipline desirable.Extensive experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.Experience in new product introductions to Biologic facilities desirable. If this role is of interest, please apply now!#LI-JS4

CQV/Qualification Engineer - Dortmund, Germany - 2-3 Months Initial ContractThis innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process. What you'll do: Develop and execute qualification documents including URS, risk assessments, IQ/OQ protocols, reports, and supporting documentation.Collaborate with stakeholders to ensure timely review and approval of documentation.Report progress, manage timelines, and ensure alignment with project milestones. What you'll need: Extensive experience in CQV/qualification engineering within the biopharmaceutical industry.Proven track record qualifying equipment such as bioreactors, ultra-filtration, chromatography, and related systems.Strong knowledge of GMP, regulatory requirements, and risk management principles.Fluent German speaker (mandatory). If this role is of interest to you, please apply now!#LI-FY1