Project Engineer

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

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

Project Manager - Ireland - 12-month contractOur 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 Manager to join the team. What you'll do:  Proven experience managing capital projects using structured project management methodologies.Ability to deliver projects on time, within budget, and to the highest quality standards while managing risk effectively.Hands-on experience coordinating project execution through the full lifecycle—from initiation to handover.Strong leadership skills with experience guiding cross-functional teams of internal and external specialists.Solid understanding of project scope, scheduling, cost control, and compliance with industry standards (PMM, cGMP, GEP).Skilled in stakeholder coordination, problem-solving, and aligning projects with business strategy.Familiarity with quality systems and safety regulations, with a proactive approach to risk and injury prevention. What you'll need:  Bachelor’s degree in engineering, science, or a related technical field (engineering preferred).Extensive experience managing projects through the full lifecycle.Proven track record in pharmaceutical or biotech environments and large company settings.Hands-on experience supervising installation activities on-site and managing contractors and suppliers.Strong financial acumen and stakeholder management skills.Expertise in scheduling, cost estimation, and controlling.Ability to analyze and solve complex problems with innovative solutions.High awareness of GMP, Data Integrity, Quality, and EHS standards.Knowledge of manufacturing processes and engineering documentation (layouts, P&IDs, supplier design docs).Experience executing automation upgrades and virtualization projects for legacy equipment.Certified Project Manager (IPMA or PMI) is a plus.Excellent communication skills and a proactive, hands-on attitude. If this role of interest to you, apply today! #LI-CB1

QA Validation Engineer - North Carolina, United States - 9-months contractOur client works across regulated sectors to build robust, repeatable compliance and validation practices. They prioritise clear guidance, clean documentation, and controls that fit how teams operate.  What you’ll do: The QA Validation Specialist is responsible for implementing, executing, and assessing quality systems, procedures, and records to support compliant GMP operations.The role works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.Provide hands‑on QA support and oversight to internal teams and suppliers/contractors to ensure compliance with applicable quality standards, regulatory requirements, and industry guidance.Review and approve commissioning, qualification, and validation documentation.Review and approve qualification and validation deviations and discrepancies, supporting investigation and corrective actions.Work collaboratively across site functions to instil a strong quality culture, coaching in the application of GMP principles and the rationale behind them.Author, review, and approve controlled documents for Quality and other GMP functions, including SOPs, specifications, protocols, and reports.Assist in the preparation for, and hosting of, regulatory inspections and audits as required. What you’ll need: Degree in biological, physical or chemical sciences, engineering, or a related field, with  experience in QA within biologics manufacturing. Strong knowledge of risk‑based approaches to qualification and validation in a biotech quality environment.Hands‑on experience with qualification and validation of process equipment, isolators, bioreactors, clean utilities, automation systems, sterile filling, and cleanroom facilities.Solid understanding of relevant regulations and guidelines, including US and EU frameworks (e.g. FDA, EMA), ICH guidance, and industry best practice.Proven track record of working in a fast‑paced team environment, meeting deadlines, and prioritising work across multiple projects.Strong analytical and communication skills, sound judgement, and the ability to work effectively with colleagues and stakeholders.Excellent problem‑solving capability, with experience in root‑cause investigation and CAPA determination. If this roles is of interest to you, apply today!

DTI Validation Lead - US, North Carolina - 12 Months Initial ContractOur client, a globally recognized pioneer in Biotechnology, are recruiting for the position of DTI Validation Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast. What you'll do: Develop and own the validation strategy for digital technology systems (e.g., MES, DCS/SCADA, Historian, lab systems, asset management tools, and digital workflow platforms).Lead CSV (Computer System Validation) planning and execution.Collaborate with engineering, automation, IT, quality, and construction teams to ensure integration and data flow meet compliance and data integrity standards.Ensure validation deliverables (URS, FS/DS, IQ/OQ/PQ, risk assessments, etc.) are created, reviewed, and approved per project timelines. What you'll need: Extensive experience in CSV/automation/IT validation within pharmaceutical or biotech manufacturing.Experience supporting greenfield/brownfield CAPEX projects highly preferred.Strong knowledge of GAMP 5, Data Integrity principles (ALCOA ), and GMP regulations.Proven leadership in cross-functional environments and vendor/contractor management. If this role is of interest, please apply now. #LI-DA1

Jr. Project Engineer - US, North Carolina - 12 Month ContractBe part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in Ohio, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for a Jr. Project Engineer to join the team and help deliver this world-class program. What you’ll do: Assist senior engineers in planning, scheduling, and executing project deliverablesPrepare technical documentation, progress reports, and compliance recordsSupport allocation of team resources and track project staffing needsMonitor construction activities and sterile environment requirements to ensure compliance What you’ll need: Extensive relevant experience in engineering or project coordinationPharmaceutical background preferred but not mandatorySteriles experience (manufacturing or cleanroom environments) and/or construction project exposure strongly desiredStrong organizational and communication skills Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-KS1

Project Controls Lead - US, Ohio - 12 Month ContractBe part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in Ohio, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for a Project Controls Lead to join the team and help deliver this world-class program. What you’ll do: Lead all project controls activities, including cost management, forecasting, schedule alignment, risk inputs, data processing, and progress measurement.Develop and maintain integrated cost–schedule (EVMS) models to ensure alignment between planned progress, actual progress, and spend.Monitor and report schedule variances, ensuring discrepancies between schedule and cost performance are identified early and escalated appropriately.Manage monthly cost reporting cycles, including accruals, trend analysis, variance identification, and “early warning” indicators. What you’ll need: Extensive project controls experience on large or medium CAPEX projects.Deep experience in cost management with strong understanding of schedule interfaces.Strong command of EVMS, progress measurement, rules of credit, and earned value forecasting.Ability to challenge schedule and identify mismatch between schedule and cost data. Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-AN1

ANC2 Site Safety Lead - US, North Carolina - 12 Months Initial ContractOur client, a globally recognized pioneer in Biotechnology, are recruiting for the position of ANC2 Site Safety Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast. What you'll do: Lead and oversee the overall safety program for the construction of a new drug substance manufacturing facility, ensuring compliance with all safety regulations and standards.Collaborate closely with the main contracting firm to ensure safety is a top priority across all phases of the project.Provide cradle-to-grave project management of safety initiatives from design through to operational start-up and handover.Manage safety elements such as permits, Pre-Start Up Safety Reviews (PSSRs), and ensure a build team that adheres to safety protocols and best practices. What you'll need: Proven experience leading safety programs for large-scale construction projects in highly regulated industries, with experience on projects ranging from $300M to $500M.Strong knowledge of safety standards, protocols, and regulations, including OSHA, MSHA, and other relevant safety certifications.Demonstrated expertise in managing safety from the design phase through to operational start-up and handover, with strong experience working on previous contracts.Experience with managing or working alongside the main contracting firm to ensure site safety. If this role is of interest, please apply now. #LI-DA1

Project Manager - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Project Manager 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 project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Manage the brand’s book of workDrive scenario planning for projects (with a focus on device, packaging & DP)Develop detailed project timelines, resource plans, and chartersCreate and manage project budgets What you’ll need: BA/BS in a life science, engineering or other technical discipline ExperienceA demonstrated track-record of success, accomplishments & delivering resultsExtensive project management experience within the pharmaceutical/biotech industryExperience with Chemistry, Manufacturing & Controls (CMC) and Packaging, Devices and Artwork desirableExperience with Chemistry, Manufacturing & Controls (CMC) and Packaging, Devices and Artwork desirable If this role is of interest, please apply now!#LI-JS5