Marcin Buczakowski

Project Manager NPI - Ireland, Dublin - 12 Month Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Project Manager NPI. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Project management of selected projects within the site’s project portfolio, potential projects could include process improvement, new system delivery and NPI (New Product Introduction) projects in our Drug Product specialism.  Lead / Support rapid improvement projects through the application of the most appropriate project execution methodology for the given business challenge (Waterfall, Agile, Scrum, etc). Work with project sponsors at initiation to ensure the project scope is fully defined and understood. Lead project management best practice by partnering with cross functional teams to ensure project execution is to plan. Resolve issues and escalate risks in a timely fashion to the relevant on-site and above-site stakeholders.  Desirable Experience: Extensive experience in working in a project management role. Experienced in the application of project execution methodologies (Waterfall, Agile, Scrum etc). Proficiency in the use of project management tools / software Experienced in leading cross functional matrix project teams Experience in MPS/Operational Excellence – Green beltMinimum of a Bachelor’s degree in Operations Management, Engineering, Science or related field Pharmaceutical industry experience.  If this role is of interest to you, please apply now!#LI-DH1

CSV Lead - Netherlands, Eindhoven - 12 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Lead. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Lead and manage the CSV team, ensuring timely completion of all deliverables.Develop all CSV master plans and documentation.Act as the lead engineer for review of PAS (existing and new), BMS, EMS, Data Historian (OSI Pi), and equipment PLC systems.Identify the full scope of computer system validation and qualification efforts (GMP and non-GMP).Create project-specific CSV plans for automation & IT systems, PAS, OSI-Pi, and standalone QC lab instruments.Support the Design Qualification effort with CSV and automation input.Attend risk assessment sessions (Complexity/Customisation, FMEA, PCL, CIL).Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.Run and coordinate weekly CSV meetings, reporting to the CQV PM. Desirable Experience: Requires extensive experience implementing and managing CSV scope on large-scale projects.Proven experience delivering projects using a verification/leveraging approach to CSV.Experience working on complex projects within the biopharmaceutical industry. If this role is of interest to you, please apply now!#LI-DH1

CSV Engineer - Ireland, Dublin - 11 Month Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Engineer.This is a fantastic opportunity to be part of a fast-paced, €400 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.   This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.Essential Duties and Responsibilities for this role include, but are not limited to, the following: Responsible for the manufacturing Process.Support creation, assessment, and completion of change control cases from Qualification/Validation Perspective.Contact to the overall project leaders in different departments and within the global project team to support project execution.Prepare assessments and documents for regulatory purposes.Lead and participate in Risk Analysis of equipment, systems and processes.Apply professional interdisciplinary project teamwork supporting the team .  Desirable Experience: Kneat and EVAL software is highly advantageous.Ample amount of professional experience in pharmaceutical Industry.Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods.Knowledge in automation and computer system validation.Project management knowledge, leadership capabilities with respect to quality topics.Experience with implementation of new pharmaceutical buildings and new line preferred.Strong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structure. If this role is of interest to you, please apply now!#LI-AE1

Project Scheduler - Ireland, Dublin - 12 Months Initial Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Project Scheduler. Essential Duties and Responsibilities for this role include, but are not limited to, the following: Drive creation of Site Portfolio Schedule (Microsoft Project)Transfer/Build the existing project schedules in Microsoft Project with connection to Primavera schedule where needed.Chair or assist with interactive scheduling workshops with various individuals and teams, to further develop the schedule.Maintain site portfolio schedule, alignment of sub project schedules, issuance of progress metrics (define and deliver).  Support site governance in mitigation plan tracking.Develop a close working relationship with the scheduler on the capital project to identify critical common milestones and workload peaks and to ensure a tightly integrated schedule.Provide weekly updates to the project manager, leadership team and site project management office using established reporting tools. Desirable Experience: Requires extensive experience working in a similar role in a pharmaceutical or preferably a biopharmaceutical environment with at least one major project involving implementation of MES and MBR. Proficiency in Primavera scheduling tool.Proficiency in Microsoft Project scheduling tool.Proficiency as a user in Microsoft Excel, Powerpoint, Word, Outlook, Sharepoint.Excellent interpersonal and communication skills, both written and verbal. If this role is of interest to you, please apply now!#LI-DH1