Cleaning Validation Expert

Location: Beerse

Duration: 12 months initially

Hours: 40 (Hybrid). 3 days on site in Beerse

about the role

The Chemical Process Research and Development (CPRD) department is seeking a Cleaning Validation Expert to join our team in Belgium. 

Within the CPRD, we have three state-of-the-art pilot plants in Beerse and Geel which support the development of new chemical processes and produce Active Pharmaceutical Ingredients (API’s) used in clinical trials. In Beerse, we have the Chemical Development Mini Plant (CDMP) with small batch reactors and solid/liquid separation, drying and milling technology and the Chemical Development Oligonucleotides Plant (CDOP) where we can support synthesis and processing of oligonucleotides. In Geel, we have the Chemical Development Pilot Plant (CDPP), where we have larger batch reactors for clinical and commercial API production. The pilot plants are constantly innovating the technology and data infrastructure to increase flexibility and end-to-end productivity for future product and development needs.

roles and responsibilities

For the 2 API Pilot Plants in Beerse (CDMP and CDOP) we are looking for a Cleaning expert. 

As a Cleaning Expert you support the first introduction of new processes in a GMP plant environment. You act as subject matter expert for cleaning introductions and guard the patient safety via the overall cleaning status (validation/verification) of CDMP and CDOP.  This will involve: 

• Manage cleaning activities on a daily support basis for CDMP/CDOP, including investigation analysis and corrective action handling.

• Manage cleaning and write cleaning procedures, protocols, and reports. Control changes via change management process and principles.

• Manage all aspects of introduction of an NPI in the plant in close collaboration with the Pilot Plant operator, engineer and manager, Scientific Integrator (SI), Analytical method development group,… e.g. requesting/gathering data (solubility, PDE, MBO,…), initiate development of new analysis methods, calculate carry-over limits etc.

• Where needed, develop and model new cleaning methods for existing equipment or for the introduction of new equipment.

• Manage the equipment cleaning validation master plan and make sure that validations and verification runs are executed on time, right first time. 

• Identify and lead cleaning improvement projects related to speed, quality, compliance, environment, safety of existing cleaning methods.

• Maintain the highest standards in quality and compliance in assuring patient safety; maintain highest standards in operational safety.

• Back-up for cleaning expert CDPP in Geel 2 days per week. (this can be done remotely or on site)

how to succeed

• Scientific master degree in Chemistry, Engineering or Bio-Engineering, or equivalent by chemical operations/development experience.

• Strong interest and preferably experience in working in a chemical operational development environment. This means short timelines, high flexibility in combination with high accuracy.   

• Knowledge of GMP is required; experience in cleaning validation is preferred.

• Strong technical interest in API synthesis equipment and strong administrative and documentation skills.

• A strong safety, quality, and compliance mindset is required.

• Successful candidate must be able to demonstrate strong cross-functional collaboration, strong communication and negotiation skills and work efficiently both individually and in a team.

• Project management experience is a strong asset (e.g. process excellence, lean principles). Candidate must show good organization skills, capable of handling multiple projects.

details

This role offers a very competitive hourly rate. 

This contract will run for a 12 month duration and has a strong chance of extension.

Hybrid working, 3 days on site

you are welcome here

is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.