Cleaning Validation Engineer
Location: Geel
Working mode: Hybrid, 3 days per week on-site in Geel and 2 days WFH
Duration: 12 months initially
Hours: Full-time, 40 hours per week
Hourly rate: Competitive hourly rate
roles and responsibilities
Cleaning Validation Engineer Role
* is member of the Manufacturing Science And Technology (MSAT) Team with dedicated focus on cleaning validation
* disposes of excellent expertise of cleaning validation processes
The process validation engineer manages through his/her expertise
* preparation and / or updating cleaning validation documentation (protocols, reports, studies etc.)
* gate keeping of proposed changes to prioritize the needed cleaning validation projects
* preparation and support of audits
* right on time introduction of NPI and new equipment in the validation program
how to succeed
Specific knowledge and performance
* Strong expertise on API manufacturing processes
* Strong knowledge in validation
* Knowledge of statistics
* Project management, organizing, planning and coordination skills
* Strong mind-set and knowledge of Quality & Compliance/ regulatory requirements (GMP) in particular in the area of cleaning validation:
* Adheres to applicable cGxP's, procedures and management systems
* Reports incidents and deviations
* Proposes solutions to improve compliance with cGMP's
* Reporting of (near) accidents, incidents, deviations
Personal and interpersonal skills
* Ability to manage complexity, strict deadlines and change
* Ability to interact at different levels of the organization
* Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly
* Customer and business focus
* Informs the manager and can call on the manager for consultation, in case of problems with stakeholders, fundamental problems concerning (technical) feasibility, etc.
* Strong skills in communication and a result driven personality.
Degree
* Master's Degree in (Bio)Sciences or Life Sciences
Languages
* Dutch, English
Specific know how of systems
* The function holder is preferably acquainted with different data and production systems, such as eLIMS, truVAULT, COMET, PRX, CRB, SAP, PASx, Minitab, CPV Automation.
benefits
This role offers a very competitive hourly rate. This contract will run initially for 12 months and has an opportunity of a contract extension.
you are welcome here
Johnson & Johnson Innovative Medicine
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 Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
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.
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".