Validation engineer

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 job of a

Validation Engineer

is to ensure that all manufacturing processes, equipment, and associated systems are validated to meet strict regulatory and quality standards. The role involves developing validation strategies, leading validation activities, writing and reviewing validation documentation and resolving validation issues and deviations.

1. General information Job (Senior) Validation Engineer Reports to Manager Engineering Unit & Department Engineering / Engineering NL Site: Amsterdam

Main Responsibilities & Accountabilities Key activities GMP roles and responsibilities

1. Validation Strategy and Planning: Develop and manage the overall validation strategy for processes and equipment, ensuring it aligns with both GMP requirements and industry best practices. Plan and schedule validation activities to efficiently support manufacturing timelines and product launches.

2. Execution of Validation Activities: Lead the execution of validation studies, including equipment validation, cleaning validation, and computer system validation. This involves drafting validation protocols, executing tests, collecting data, and analyzing results.

3. Regulatory Compliance: Ensure that all validation activities comply with relevant regulatory standards such as FDA, EMA, and ICH guidelines, as well as specific GMP requirements. Stay updated on regulatory changes and adapt validation strategies accordingly.

4. Risk Management: Implement risk management strategies in validation processes. Identify potential risks associated with process and equipment operations and develop mitigation strategies to ensure continuous compliance and performance.

5. Vendor and Contractor Management: Oversee and manage relationships with vendors and contractors involved in the validation process. Ensure that all external partners comply with the same quality and regulatory standards as internal processes.

Your profile

Bachelor degree in Automation Engineering, or a related field. At least 5 years of experience, pharma/GMP regulated environment. Strong background in either PLC, SCADA, DCS or MES and 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.