Cleaning Validation Engineer

Description:

The Cleaning Validation Engineer plays a crucial role in the development, validation, and enhancement of cleaning processes for equipment and tools (excluding the environment). This role involves specializing in various cleaning technologies ranging from manual to automated cleaning and collaborating with a team of other cleaning validation engineers.

In practice, the Cleaning Validation Engineer typically focuses on one or two specific areas within the Heist Production Operations, becoming an expert and the primary point of contact for all cleaning-related projects and issues in that area. He/she is expected to have a deep understanding of all technical aspects of the cleaning processes (hardware, software, etc.), as well as the needs and challenges of the production team.

The role supports all cleaning aspects of new product and equipment introductions and leads proactive and reactive improvements to existing cleaning processes. This includes using the change control system, writing plans, protocols, and reports, and executing studies (taking samples, coordinating with labs, etc.). The Cleaning Validation Engineer also handles deviations and urgent issues in production to ensure operational continuity. This may occasionally require flexibility, such as changes in daily planning, coming to the site when working from home, or working overtime or early/late shifts.

To maintain compliance, the role includes periodic processes such as paper-based reviews and actual sampling programs, in which the engineer plays a key role. Over time, the Cleaning Validation Engineer may be recognized for their expertise and asked to be the site topic lead, participating in above-site teams with other cleaning validation experts.

Your Profile:

• Higher scientific degree (e.g., Pharmaceutical Sciences, Bioengineering, Industrial Engineering)
• At least 3 years of relevant experience in validation and/or project management in a GMP production environment (experience in cleaning validation is a significant plus and almost a must-have)
• Hands-on experience in regulated pharmaceutical manufacturing environments with a flexible attitude (occasional early or late shifts, extra hours, weekend work to support business continuity of production processes)
• Knowledge of operating principles of cleaning and CIP (Clean-In-Place) processes is a significant advantage
• Analytical mindset and project-oriented
• Excellent communication skills to work effectively with a range of workers (from operators on the shop floor to IPT directors to report progress)
• Team player
• On-the-floor approach
• Customer-focused
• Outstanding influencing skills
• Process and data-driven
• Problem-solving skills to investigate failing validation data
• Fluency in both Dutch and English (verbal and written)

Home-based work is possible for up to 2 days per week, in consultation with co-workers.