James Smithson

Warehouse Specialist - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for a Warehouse 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: Execute all tasks associated with WCL processes, including receiving, sampling, raw material storageQuality Inspection of incoming ConsumablesGMP Sampling of all of the sites Raw Materials, working in an ISO7 (Grade C) area, utilising Downflow Booths, Fume hoods, Bio-Safety Cabinets and Nitrogen Overlay processesSupply Manufacturing area with required materials in a timely manner to support the manufacturing schedule, ensuring a high level of internal customer service. What you’ll need: An ability to work independently and also as part of a team.High degree of problem solving ability and adherence to scheduled timelines.The Leaving Certificate is a minimum requirement, a third level qualification in logistics and/or manufacturing is preferred.Extensive GMP and Biologics manufacturing experience.  If this role is of interest, please apply now!#LI-JS4

CQV Engineer (Inspection) - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Inspection) 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 Inspection Systems including Syringe and Vial Automated Visual Inspection Equipment and Manual Inspection Booths 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 Inspection equipment, is tested in compliance with project related standards from a commissioning perspective. What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Extensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Excellent communication skills and the ability to influence others.Demonstratable experience working in teams in a matrix environment to deliver CQV elements. If this role is of interest, please apply now!#LI-JS4

CQV Engineer - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a CQV Engineer (Clean Utilities) 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 Clean Utilities for the Sterile Drug product facility.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 and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all equipment, Utilities are tested in compliance with project related standards from a commissioning perspective. What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Extensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.Excellent communication skills and the ability to influence others.Demonstrable experience working in teams in a matrix environment to deliver CQV elements. If this role is of interest, please apply now!#LI-JS4

Operational Excellence Specialist - Ireland, Sligo - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for an Operational Excellence Specialist 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: Responsible for executing continuous improvement efforts throughout the company to meet service, quality and cost objectivesSupport excellence in the day-to-day management of the business through implementation and maintenance of daily management tools.Support functional leadership and assigned teams with development of both strategic project portfolios and detailed project plansEstablish/maintain network of change agents and be the focal point for continuous improvement expertise and troubleshooting within all support functions. What you’ll need: Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;Support a culture of EHS excellence by recognising and submitting opportunities for EHS improvement on eAchieve. If this role is of interest, please apply now!#LI-JS4

NPI Compliance Specialist - Sligo, Ireland - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a NPI Compliance Specialist 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 ensure new products are manufactured following applicable regulatory requirements and policies.Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.Support review and approval of NPI related Analytical Test Method Transfers and/or validation. What you’ll need: A third level qualification in a science, quality or relevant discipline.A minimum of three years experience in a quality role supporting new product introductions.Strong knowledge of regulatory requirements is requiredRegulatory, quality and New product introduction background.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

CQV Engineer Benchtop Equipment - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Benchtop Equipment 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: Development and execution of CQV testing documentation for benchtop, mobile, analytical, PAT, incubators, BSCs, and TCU equipment for the Sterile Drug product facility.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.Deviation management associated with the assigned equipment and utilities. What you’ll need: The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering disciplineExtensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.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. If this role is of interest, please apply now!#LI-JS4

CQV Engineer - Formulation & Component Prep - Dublin, 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: Development and execution of CQV testing documentation for Equipment for the Sterile Drug product facility.Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment 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 non GMP equipment, are tested in compliance with project related standards from a commissioning perspective.Deviation management associated with the assigned equipment and utilities. What you’ll need: The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering disciplineExtensive experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.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. If this role is of interest, please apply now!#LI-JS4

Cleaning Validation Engineer - Dublin, Ireland - 12 Months Initial ContractOne of the top 10 best companies to work in Ireland is looking for a cleaning validation 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: Performing all aspects of cleaning sampling required for cleaning validation for a new product.Activities include swab and rinse sampling, sample preparation, LIMS administration, submission to QC for analysis, correlation of QC results with cleaning change over protocols/ cleaning logbooks.Supporting product changeover activities.Assisting with LOTO (lockout/ Tagout) activities where required.Generation of standardized cleaning validation ECPs (Energy Control Plans). What you’ll need: A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline.Previous cleaning validation experience is an advantage.The ideal candidate would have biopharmaceutical Process / Validation knowledge.Exposure to cGMP in a fast-paced environment is required.Previous experience in working in a drug product filling facility would be advantageous. If this role is of interest, please apply now!#LI-JS4

QA Specialist - Dublin, Ireland - 12 Month Initial ContractOne of the top 10 best companies to work in Ireland is looking for a 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. What you’ll do: Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems.Ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements.Supporting the QC laboratory through global regulatory agency inspections and achievement of market approvals.Supporting the execution of the internal audit program.Supporting QC and QA Network Harmonisation initiatives. What you’ll need: BSc in Science or related discipline.Extensive Quality experience in the biopharmaceutical industry.A thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.Excellent written and verbal communication skillsAbility 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