Cleaning Validation Specialist

The Job

As a Cleaning Validation Specialist, you will be working as a subject matter expert (SME) and process owner in numerous Engineering projects regarding development and improvement, modification and new installations, validation and evaluation of processes, systems and equipment and you will be responsible for the strategy and coordination of all validation-related affairs. In addition, you will lead multidisciplinary projects within your specialism. You will also set the policies regarding Cleaning Validation within Prothya and ensure that we grow along with the changing cGMP needs. Furthermore, you will identify existing gaps and develop mitigation programs for this and put them into effect. Aiming that the preparation of products improves and can continue to proceed according to current (inter)national quality standards.

Cleaning validation focuses on the following domains:

• Maintenance of a validated status of the cleaning processes;
• Validation of cleaning processes for new and upgraded equipment;
• Support in case of cleaning problems;
• Improving cleaning processes in terms of compliance, control, robustness and consumables
• Quality support, such as review of qualification protocols, drawing up procedures and carrying out periodic reviews;
• Operational support and resolution of non-routine complex production problems;
• Qualifications in everything related to the mixing studies and qualification of the temperature homogeneity in production tanks.

From a project role, you will be participating in or leading projects to optimize the production installations. From their focus area, you take care of the development and/or delivery of various project phases: planning, implementation, testing and validation up to the final aftercare and transfer of the project. 

Main responsibilities and result areas:

1. Acting as Subject Matter Expert (SME)

• You act as owner and manager of the methods, processes and systems used with regard to the specialism within production.
• You are an advisor for production problems / deviations in the production process related to the specialism and you are the problem owner in complex cases, assess the impact and advise on solutions.

2. Planning

• You analyze the needs of your internal customers in terms of your specialization focus and define the engineering objectives.
• You make proposals with regard to improvements and/or innovations and convert this information into a project schedule.

3. Implementation

• You take care of the implementation of the new installations within your focus area and you are responsible for the follow-up of internal and external project employees.
• You play an active role in troubleshooting during the implementation phase.

4. Testing and validation

• You organize, supervise and document tests and qualifications.

5. Aftercare and transfer

• You play an active role in the commissioning of your subproject.

6. Additional Department Specific Tasks

• You use different software systems for manufacturing and security (MES, QMS, …).
• You manage additional administration depending on the projects and quality (drawing up SOPs, user specifications, training strategies, etc.).

Your Profile

• Education level: Academic degree in biotechnology, chemistry, chemical technology or food technology;
• You have at least 5-10 years of experience in the pharmaceutical sector, experience in a quality-driven sector is a must (pharmacy, food, chemistry, etc.).
• Knowledge and understanding of processes, process technology and research techniques
• You are familiar with GMP guidelines (Good Manufacturing Practices) and SOPs (Standard Operating Procedures).
• You can easily work with the MS Office package and other software packages.
• You are fluent in English and knowledge of Dutch is a strong plus.
• You are analytical and feel at home in a project environment.
• You can manage several projects at the same time, set priorities and you have strong organizational skills.
• You are communicative and enjoy working together.
• You are customer and service oriented.
• You are stress-resistant and result-oriented.

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 PFZW.

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.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.