Senior Project Lead Engineering

About the Vacancy

Prothya Biosolutions develops life-saving plasma-derived medicines and takes great pride in doing so. Every day, Prothya colleagues go the extra mile with dedication and passion to improve the health of millions of patients worldwide. Are you looking for a role within a flexible and growing company with a rich and inspiring history?

The primary purpose of the

Senior Project Engineer

role is to manage and/or actively participate in engineering projects, while leading or advising on technical matters and ensuring that all activities are conducted in compliance with Good Manufacturing Practices (GMP). This position involves planning, executing, and successfully closing projects related to both drug substance and drug product manufacturing. The focus is on improving operational efficiency, ensuring the highest quality standards, and maintaining a safe working environment.

1. General information Job Project Lead Engineering Reports to Manager Engineering Unit & Department Engineering / Engineering NL Site Amsterdam

Purpose of the job The primary purpose of the job of a project lead engineering is leading engineering projects from start to finish, ensuring that all activities are conducted in compliance with Good Manufacturing Practices (GMP). The role involves planning, executing, and closing projects that relate to both drug substance and drug product manufacturing, with a focus on improving efficiency, ensuring quality, and maintaining safety standards.

2. Main Responsibilities & Accountabilities Key activities GMP roles and responsibilities

1. Project lead: Lead multiple large engineering projects from concept to completion, including project planning, budgeting, scheduling, and execution. Some projects will include internal project teams of several people, other projects will have to be executed mostly independently while relying more on external companies. Project examples include cleanroom reconstructions, capacity increases, efficiency gains, tech transfers and other large multidisciplinary engineering projects

2. GMP Compliance: Ensure all engineering activities comply with GMP, FDA, EMA, and other relevant regulatory requirements. Maintain comprehensive documentation for all projects to ensure traceability and compliance during audits and inspections.

3. Technical Leadership: Provide expert technical input on the design, installation, and qualification of new equipment and systems to ensure they meet GMP and Good Engineering standards. Independently write and/or review GMP documentation, such as change controls and qualification documents

4. Stakeholder and vendor management: Communicate project status, risks, and issues to stakeholders, including senior management, and clients. Facilitate effective communication and collaboration between various departments, including production, quality assurance, and regulatory affairs. Prepare and present detailed reports and project updates to stakeholders. Oversee activities performed by with vendors and contractors involved in engineering projects. Communicate and negotiate with vendors that deliver parts of the project.

Your profile

Master’s/Bachelor degree in Engineering, or a related field. At least 5 years of experience, pharma/GMP regulated environment. Strong background in either project lead and/or manager experience highly preferred

Our offer A fulltime employment of 40 hours per week A market-rate salary A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly A personal training budget of €2,100 every three years to foster professional growth and development. Flexible working hours after deliberation Your own place in a close-knit and expert team with an employer that stimulates growth and personal development Contribution to travel expenses from the first kilometer Excellent accessibility by public transport and private parking available. Sound pension provision.