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

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

QC Analyst Material Management - Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a QC Analyst, Material Management 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: Performing QC testing (TOC, pH Conductivity) of water samples. Performing analysis of Raw Materials including HPLC, KF, UV, IR and wet chemistry techniques. Completion in a timely and accurate manner of laboratory documentation as directed by the QC Material Management Supervisor.Compliance with Standard Operating Procedures and Registered Specifications.Assisting in authoring and reviewing documentation, including SOPs, as required.Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures.Supporting technical transfer of new projects.Assisting with out of specification investigations and deviations using the Infinity system.Sample management activities- ensuring chain of custody is maintained using CIMS and LIMS. Key requirements include: 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 along with extensive experience in a pharmaceutical / healthcare laboratory or related technical function. If this role is of interest, please apply now!#LI-JS4

Qualified Person - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for Qualified Person 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: Qualified Person certification and batch release of clinical suppliesActs as a Responsible Person on a WDA for Pre-Approval AccessSupport for Health Authority GMP/GDP inspections and audits across the supply chainAdvise stakeholders on quality issue management and process enhancement/complianceIncorporate global regulatory trends and changes into Supply Chain QualityManufacturers Authorisation update and maintenanceEnsure rapid communication of quality issues or significant deviations, to business partners and senior managementReview and approve procedural documents Key requirements include: Must be eligible to act as Qualified Person on the Manufacturing/Importation AuthorisationPrevious experience as a Responsible Person on a WDA is preferredDemonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality AssuranceProven track record of building/ maintaining high-performance teams/organisations and influencing/ motivating global teams to achieve results—delivering on business and program goalsProven leadership / influence management skillsProven clear communication supporting delivery for the business If this role is of interest, please apply now!#LI-JS4

Project Engineer - Ireland, Westport - 12 Months Initial 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. Essential duties and responsibilities for this role include, but are not limited to, the following: Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g., Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels, Containment booths & Stopper processing eq.Writing User Requirement Specifications.Selecting Vendors and completing Vendor evaluation matrix.Writing RCE's, placing orders, Project Management & Design review meetings.Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.Lead the Project Team participation in Factory Acceptance Testing program. Desirable Experience: Third level qualification in an Engineering or equivalent discipline/experience.Experience of working in Biologics, Pharmaceuticals or Medical device industry.Project Management experience with a proven record.Assured self-starter with proven Technical ability.Good communication and Interpersonal skills required to operate in a multi-function project team set up.Good team leading skills and ability to work closely with other areas/departments within an organisation. If this role is of interest, please apply now!#LI-JS4