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Posted 1 day ago

Qualified Person

ContractCounty Dublin, Ireland

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

Posted 1 day ago

Project Engineer

ContractBray, County Wicklow, Ireland

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

Posted 1 day ago

Project Engineer Process Equipment & Utilities

ContractBray, County Wicklow, Ireland

Project Engineer Process Equipment & Utilities - 12-month contract - IrelandOur 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:  Manage capital projects using structured methodologies, ensuring delivery on time, within budget, and to the highest quality standards.Lead cross-functional teams of internal and external specialists through the full project lifecycle—from concept to handover.Coordinate project execution activities, including design, procurement, installation, and commissioning.Ensure compliance with PMM, cGMP, GEP, and organizational standards.Facilitate stakeholder engagement, problem-solving sessions, and alignment with business strategy.Oversee quality systems and enforce EHS requirements throughout project execution. What you'll need:  Extensive experience executing full project lifecycle: concept design, CapEx applications, procurement, scheduling, scope management, supplier interface, EHS inputs, equipment installation, and CQV.Strong knowledge of pharmaceutical manufacturing processes and engineering documentation (layouts, P&IDs, supplier design docs).Familiarity with current pharmaceutical engineering practices and GMP regulations.Hands-on involvement in shop-floor installation activities and contractor management.Bachelor’s degree in engineering, science, or related technical field (engineering preferred).Extensive experience managing projects/programs through full lifecycle with budgets up to €3M.Proven background in pharmaceutical or biotech environments and large company settings.Strong financial acumen, leadership, and stakeholder management skills.Expertise in scheduling, cost estimation, and risk management.Ability to analyze and solve complex problems with innovative solutions.High awareness of Quality and EHS standards.Certified Project Manager (IPMA or PMI) is a plus. If this role is of interest to you, apply today! #LI-CB1