Loto Consultant

CSA Project Manager - 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 CSA Project Manager to join the team and help deliver this world-class program. What you’ll do: Oversee all CSA-related design, procurement, and construction activities for the project.Act as the main bridge between design teams, procurement, and on-site construction for CSA scopes.Ensure timely and accurate communication of deliverables, change orders, and technical issues.Manage integration between CSA and other disciplines (equipment, clean room, etc.) to maintain schedule and budget.Provide leadership in project meetings, ensuring all action items and reporting requirements are completed.  What you’ll need: Strong background in civil, structural, and architectural project management within large-scale construction or pharmaceutical projects.Previous experience managing complex design packages and working on multidisciplinary teams.Familiarity with construction phases, field coordination, and technical submittals.Ability to review and oversee design changes, procurement requirements, and construction alignment.Proven success in matrix organizations, coordinating across functions. Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-AN1

Operational Readiness Planner/Scheduler - US, Ohio - 12 Months Initial 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 Operational Readiness Planner/Scheduler to join the team and help deliver this world-class program. What you’ll do: Create and maintain the operational readiness schedule using Microsoft Project or Oracle Primavera P6.Coordinate with the project team and stakeholders to collect and update the schedule information and data.Perform schedule analysis and identify critical path, dependencies, milestones, and deliverables.Provide schedule reports and dashboards to the Operational Readiness Project Manager and other project stakeholders. What you’ll need: Bachelor’s degree in Engineering, Business, or other relevant discipline.Extensive experience in project scheduling and two to three years of experience working in pharmaceutical/biotechnology industry.Experience working in a GMP environment preferred.Experience Oracle Primavera P6 project scheduling software. Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!#LI-AN1

E&I Lead - Denmark, Copenhagen - 12 Months Initial ContractOur client, a global pharmaceutical company, are looking for an E&I Lead to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems. What you'll do: Robust personalities who can strongly and confidently manage the EPCM/VExperience liaising with senior stakeholders client side and with key project partnersAbility to manage E&I works taking place on a specific scope of works within the construction execution and hand over phases.They will work alongside the EPCM/V and provide direction on areas that can be exploited. What you'll need: Capex project experience over a number of years in a lead or management functionClient-side experience, whilst EPCM experience is useful, those with client side exposure will be of preference If you would like to apply or find out more, get in touch now!#LI-BS1

CQV Owners Representative - Copenhagen - 12 Month ContractOur client, a global pharmaceutical company, are looking for a CQV Owners Representative to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems. What you'll do: Work as Owners rep witnessing CQV contractor, people with enough knowledge to spot when something is wrong and know how to work within a project to get this rectified, ensuring CQV contractor delivers to scope1 Utilities and 1-2 Recovery/Clean Utility focusedEnsure that Commissioning, Qualification, and Validation (CQV) activities meet project and regulatory requirements. What you'll need: Must have experience managing large construction projects (500mn )Client-side experience is preferredStrong experience and proof having worked in a similar role/project. If you would like to apply or find out more, get in touch now!#LI-SC1

HVAC Lead - Denmark, Copenhagen - 12 Months Initial ContractOur client, a global pharmaceutical company, are looking for a HVAC Lead to join their team. The company has grown to become a world leader in the development, manufacture, and marketing of innovative pharmaceutical products to alleviate some of the world’s biggest health problems. What you'll do: Work alongside the EPCM/V and provide direction on areas that can be exploited. The site is huge and they need to help improve the delivery of the EPCM/VIdentifying opportunities to improve scheduleEnsure EPCM/V progress reporting is accurate and if not ensure this is resolvedEnsuring EPCM/V are allocating enough bodies into right areas to achieve required progress What you'll need: A strong background on previous project work in the Pharmaceutical IndustryRobust personalities who can strongly and confidently manage the EPCM/VStrong HVAC experience. If you would like to apply or find out more, get in touch now!#LI-JS5

Project Manager - Ireland, Arklow - 12 Month Contract Are you local to Arklow and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Project Manager to join their newly assembled team and help contribute towards the development of their next core projects.   What you'll do: Build relationships with the site teams, manage the projects, and execute improvement initiatives to drive growthDrive projects to ensure complianceMaintaining working with appropriate stakeholders (QA, Maintenance, Capital) to improve unit efficiency and performanceDevelops a knowledge and understanding of products/systems/services, customers and customer needs of business area supported.Conducts feasibility studies, determines manpower and cost estimates, and develops engineering criteria. What you'll need: Primary Degree in Mechanical / Process / Chemical / Electrical EngineeringExtensive Project Experience with knowledge and exposure to Process Plant, Utilities, Electrical, Maintenance & Facilities systems and ideally within a highly regulated GMP environmentUnderstanding of GMP and the Quality standards required in the Pharmaceutical Manufacturing sectorAPI Previous experience ideally If this role is of interest to you, please apply now!#LI-FY1

Lab CSV Engineer - Dublin, Ireland - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Lab CSV 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: Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures. What you’ll need: Bachelor's degree in Computer Science, Engineering, or a related field.Experienced in computer systems validation (CSV) from requirements to through release of analytical instruments used in Quality Control (QC) laboratories or in manufacturing operations as part of Process analytical Technology (PAT).Experienced in computer systems validation (CSV) of server / database-based laboratory software, middleware and enterprise applications, for example LIMS, Empower, NuGenesis.Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for analytical instruments and software systems.Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.  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