James Smithson

QA Compliance and Systems Specialist – Dublin – Pharmaceuticals One of the top 10 best companies to work in Ireland is looking for QA Compliance and Systems Specialist 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: Preparation, review and approval of Material Qualification Documentation.QA disposition of raw materials, level 1 & level 2 consumables.Authoring, review and approval of QA-related procedures.QA review, assessment and approval activities for Biologics Manufacture, as applicableBe a core team member of the QA Compliance Materials Management team engaging in other support activities as required. What you’ll need: BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environmentA clear understanding of cGMP requirements for manufacturing and/or systems and complianceKnowledge of material qualification & SAP would be a distinct advantage.Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines. If this role is of interest, please apply now! #LI-JS4

QA Senior Specialist – Dublin – Pharmaceuticals One of the top 10 best companies to work in Ireland is looking for QA Senior Specialist 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: Support the Qualified Person with the Batch Certification functionPrepare and review batch documentation packages for QP release as per SOP requirementsLiaise with the Supply Chain and Quality colleagues to ensure that disposition lead times are consistently metUpdate SOPs, controlled documents i.e. FORMS and OJTsAssist in new product introduction activities as requiredProvide training to new team members What you’ll need: A degree in science, engineering or related discipline is essential. Experience in pharmaceutical /biopharmaceutical industryExperience using data or electronic document management systems (DCA, Trackwise, Infinity, and SAP)Strong working knowledge of Microsoft Excel and PowerPointAbility to work on his/her own initiative in addition to working as part of a team If this role is of interest, please apply now! #LI-JS4

Upstream Associate Scientist - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for an Upstream Associate Scientist 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: Support commercial and product technical transfers including late-stage process characterisation programs.Design and execution of experiments with an ability to interpret data in upstream cell culture to support NPI, process characterisation and site operations.Media preparation and development supporting lab and manufacturing upstream processes.Preparation of laboratory operating procedures, study protocols and reports. What you’ll need: An MSc. in Biological or Chemical Sciences/Engineering is preferred or BSc, extensive industry and/or academic experience.Practical knowledge of cell biology, protein expression, protein structure and function and experience with cell culture or fermentation laboratory activities.Candidates must possess good organisational skills and strong attention to detail.Demonstrates ability to troubleshoot, interpret and discuss data.  If this role is of interest, please apply now!#LI-JS4

Automation Engineer SCADA - Remote Working - 6 Months Contract Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for an Automation Engineer SCADA  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: Lead and support the deployment of Ignition SCADA solutions across multiple sites within the organisation.Maintain, standardise, and optimise global use case templates for consistent SCADA deployment.Roll out global templates, ensuring uniformity and best practices across all deployments.Collaborate closely with IT and engineering teams to develop interfaces between Ignition and various enterprise-level systems (ERP/MES/LIMS/etc.). What you’ll need: Bachelor’s degree in Engineering, Computer Science, or a related field.Extensive experience working on pharmaceutical automation projects, with expert hands-on knowledge of Ignition SCADA.Understanding of regulatory requirements (GMP, FDA, etc.) within the pharmaceutical industry.Proven track record of deploying SCADA solutions globally and maintaining standard templates or design assets. If this role is of interest, please apply now!#LI-JS4

QA Specialist - Ireland, Dublin - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for QA Specialist 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.Responsibilities include:  Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.Generates and maintains Product Specification Files (PSF) for IMP.Provides QA support and oversight of packaging and labelling operations for IMP.Support the generation and ongoing maintenance of Quality Agreements.Provides Quality Assurance support in the Use Date Extension process.Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia) Key requirements include: A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industryDemonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality AssuranceRequired to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.Excellent communication, presentation and critical thinking skills are essential. If this role is of interest, please apply now!#LI-JS4

CQV Engineer (Filling) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Filling) 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: Development and execution of CQV testing documentation for filling line systems including Syringe and Vial line/ isolators, Lyos and associated equipment for the Sterile Drug product facility. 100%Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all equipment, is tested in compliance with project related standards from a commissioning perspective. What you’ll need: Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation. If this role is of interest, please apply now!#LI-JS4

CQV Engineer (Small Equipment) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Small Equipment) 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: Development and execution of CQV testing documentation for benchtop, mobile, analytical, PAT, incubators, BSCs, and TCU equipment for the Sterile Drug product facility.( 100%)Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all equipment, is tested in compliance with project related standards from a commissioning perspective. What you’ll need: Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.Experience in CQV of Drug Substance/Drug product small equipment with integrated automation. If this role is of interest, please apply now!#LI-JS4

Tech Transfer Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Tech Transfer 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: Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scaleTo provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolutionAuthoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. What you’ll need: Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements. If this role is of interest, please apply now!#LI-JS4

BioProcess Associate - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a BioProcess Associate 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.Responsibilities include: Working with the manufacturing operations group, project design team, the CQV team, & the Automation/CSV reps to facilitate the implementation of the project design and validation of the MPCC manufacturing facility.Creation of operating procedures & other relevant documentation for large scale manufacturingExecution of commercial manufacturing processes according to established work instructions.Adheres to Good Manufacturing Practices and Standard Operating Procedures.Takes part in investigations and optimisations of processes using scientific, engineering and lean principlesOperates all production equipment within the assigned functional areaEffectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative and provide input to related investigations and QA audit activities.Engages in and supports culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and safe work environment. Key requirements include: The successful candidate will ideally possess a minimum of Level 6 qualification in an Engineering/Science related discipline; however, relevant experience in a similar regulated industry will also be considered (e.g. cGMP, ISO or similar cleanroom industry experience strongly preferred)Requires extensive working experience in a large-scale biopharmaceutical manufacturing facilityExperience with Delta V and MES would be considered an advantage.The successful candidate must demonstrate an ability to work independently and also as part of a team.The successful candidate must demonstrate problem solving ability and to adhere to scheduled timelines.Excellent communication skills and the ability to work in a cross functional collaborative environment are required. If this role is of interest, please apply now!#LI-JS4