Validation Engineer

TMC; Boxmeer; On-site; EUR 60,000 - 90,000; Full time

Job summary

TMC is seeking a Validation Engineer to lead validation activities within a highly regulated pharmaceutical environment. You will perform PQs focused on cleaning and sterilization validation, and you will develop validation master plans, protocols, and final reports.

You will collaborate with internal and external stakeholders, manage validation studies, ensure SOPs are current, and quickly adapt to new IT systems with a high degree of accuracy.

Qualifications

• Strong technical mindset and high accuracy.
• Ability to quickly become proficient in new IT systems.

Responsibilities

• Perform Equipment Performance Qualifications (PQ), with focus on cleaning and sterilization validation.
• Prepare Validation Master Plans (VMPs), validation protocols, and final reports.
• Conduct validation studies and analyze and report results.
• Maintain SOPs and other relevant documentation to ensure they remain up to date.
• Identify, analyze, and resolve technical issues arising during validation studies.
• Work with filters and/or PUPSIT as part of validation processes.
• Manage and implement changes within change management processes.

Job description

About this vacancy

As a Validation Engineer, you are responsible for validation activities across various technical projects within a highly regulated pharmaceutical environment.

You work both independently and as part of multidisciplinary teams on activities including:

• Performing Equipment Performance Qualifications (PQ), with a specific focus on cleaning and sterilization validation;
• Preparing Validation Master Plans (VMPs), validation protocols, and final reports;
• Conducting validation studies and analyzing and reporting the results;
• Maintaining SOPs and other relevant documentation to ensure they remain up to date;
• Identifying, analyzing, and resolving technical issues arising during validation studies;
• Working with filters and/or PUPSIT as part of validation processes;
• Managing and implementing changes within change management processes.

You collaborate with a variety of internal and external stakeholders while also being capable of independently managing and executing validation projects. You have a strong technical mindset, a high level of accuracy, and the ability to quickly become proficient in new IT systems.