The Project Manager Automation will provide strategic leadership and operational excellence in the planning, execution, and completion of automation projects within Prothya BioSolutions. The Project Manager is responsible for optimizing the facility’s technological capabilities through effective management of small to large-scale capital expenditure (CapEx) projects. This involves coordinating multidisciplinary teams, managing financial resources, and ensuring all activities align with industry compliance standards and organizational objectives. Ultimately, the Project Manager aims to enhance operational efficiency, ensure product quality, and deliver maximum return on investment (ROI) for automation projects.
Scope of projects include Process Automation, Industrial IT and other PLC/SCADA/MES projects.
Reporting hierarchy; Global PMO Manager
Your responsibilities
1) Initiating projects
To spearhead the planning and execution of automation projects, ensuring alignment with organizational objectives and timelines following Prothya System Development Lifecycle (SDLC) framework for Computerized systems validation.
- Identify Sponsor and Stakeholders involved in the projects;
- Coordinate project proposals and project plans, and ensure correct communication;
- Determine the scope of the project by collecting wishes and requirements;
- Determine tasks, activities, roles and responsibilities for the project team members;
- Prepare project related budgets and business cases;
- Carrying out risk analyses;
- Determine project timelines and quality of deliverables
2) Managing projects
- In terms of Project Engineering: you are responsible for basic and detailed design complying with project objectives and site specifications and requirements.
- Deliver projects within budget, quality, schedule and scope as per the Prothya Project Management Standard, and communicate warnings and deviations.
- Ensure project compliance with FDA, GMP, and other relevant guidelines documentation that adheres to regulatory requirements and industry best practices for computerized systems.
- Analyze the impact of changes on time schedule, budget, scope, quality and agreements made in such a way that the strategic objectives are achieved. Ensure alignment and approval with Sponsor and Stakeholders in making appropriate decisions to achieve strategic objectives and being responsible for implementing them;
- Identify and assess problems and risks in the planning - the progress - the quality - the results and agree on solutions with the Sponsor and Stakeholders;
- Act as the point of contact for Sponsor and Stakeholders and report periodically on the progress of projects and interim project results;
- Manage the promotion of the interests of Sponsor and Stakeholders;
- Communication: ensure a transparent, fluent and effective communication with all internal stakeholders as well as with external partners.
3) Completing projects
- Evaluate projects, including reporting of realized benefits in relation to the business case, record lessons learned and transfer any remaining points to the organization;
- Present and explain project results to the Sponsor and Stakeholders;
- Ensure transfer, archiving and assurance of project results in the organization.
- Be accountable for the financial completion, the delivered products, their quality and the time required to realize them;
- Complete agreements and contracts and transfer them to the organization.
Your profile
- Engineering master’s degree, with industrial background in OT and/or IT competences, or in automation and/or instrumentation, or related engineering field
- Minimum of 8 years of professional experience among which at least 4 years in project management position preferably within pharmaceutical industry, in a production environment.
- A good understanding of computer systems, software applications, and validation processes, as well as knowledge of relevant regulations such as GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
- Experience in IT, automation or QC computerised systems
- Experience with Industrial IT, PLC/SCADA and/or MES systems.
- Knowledge of project management systems and tools (eg MS Office, MS Project) and project management methodology
- Knowledge of GxP, cGMP procedures, EMA/FDA requirements & risk management tools HAZOP/FMEA
- Strong English speaking and writing skills. Preference for also Dutch speaking/writing.
- Knowledge and experience in plasma or other proteins manufacturing environment is a strong plus.
- You are able to build up the necessary (technical) knowledge and to bring innovative ideas to keep improving.
- You are able to multitask and know how to set priorities. You have hands-on mentality and eagerness to dive into the content.
- Talent for writing clear and complete documents.
- Strong planning, communication and organizational skills.
- Team player and team coach versed in different disciplines.
- Analytical and structural attitude.
- Independent.
- Problem solving ability with a broad area of interest.
- Proactive, and flexible
Our offer
We offer you a full-time job and a one-year contract to begin with. The following employment conditions apply:
- Full-time employment
- 8.33% end of year bonus and 8.33% holiday allowance
- Flexible working hours in consultation
- Personal training budget of €2,000 per 3 years
- Contribution to travel expenses from the first kilometer
- Good accessibility by public transport and private parking
- Pension plan at Zorg & Welzijn.
Learn More
If you want to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your CV and motivation via the apply button on this page. We aim to give you a response back within a week.
