Senior Quality Engineer

Quality Engineer

Location: Beerse, Belgium

Duration: End of 2025 

Fluency in Dutch and English required.

Imagine your next project as a Quality Engineer, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

the function holder is:

• Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews

• Responsible to ensure compliance of qualification activities.

• Responsible for review and approval of qualification documents.

• Responsible for review and approval of calibration and maintenance records

• Responsible for review and approval of certification master data.

• Responsible for review and approval of master data E6 notifications (eStream), change controls records and quality issue/investigation records, including corrections and CAPAs during execution of qualification activities and during the life cycle of the facility, system and equipment.

roles and responsibilities

• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification and system data governance 

• Participate in system introduction and system change projects and assure quality and compliance aspects.

• Assuring that the qualification status is maintained during assessment and execution of changes and projects 

• Ensuring that all system changes that may have impact on quality, compliance or registration, are evaluated and approved in order to execute adequate control, documentation and qualification.  

• Review and approval of qualification documents such as (system level) Impact Assessment critical aspect risk assessments (General) User Requirements ((G)URS), DQ/IQ/OQ/PQ protocols & reports, QSR, Test- and traceability matrices, …for compliance to regulations, guidelines and J&J procedures.

• Review and approval of Periodic System Quality Reviews (PSQR) and Area Validation Master Plans (VMPs)

• Ensuring that deviations related to systems (qualification, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.  

• Responsible for review and approval of calibration/certification procedures, calibration rationales, calibration master forms and completed calibration records.  

• Responsible for review and approval of preventive maintenance procedures and master forms.

• Responsible for review and approval of parameter lists, alarm lists and transmission lists and other documents in eSTREAM

• Responsible for review and approval of qualification / system related procedures/work instruction.

• Make sure that all deliverables out of qualification are implemented in the quality systems: SOPs, Work instructions, Calibration records, Maintenance plans, …

• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits

• Interact regularly with other functional groups/departments involved in qualification projects to assure that timelines for system qualifications are met and the cross-department objectives are realized

• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements.

cGxP / ATMP

• Always uses the appropriate cGxP  and procedures.

• Reports incidents and deviations.

• Proposes solutions to improve compliance with cGMPs.

Safety, Health & Environment (SHE)

• Always uses the appropriate prevention rules and procedures.

• Uses the available personal and collective protection materials correctly.

• Works neat and tidy.

• Reports (near) accidents, incidents, deviations and risky situations. 

• Cooperates on and suggests solutions to improve safety, health and environment.

• Participate actively on promotion campaigns, working on the safe behavior program, prevention controls.

• Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behaviour.

how to succeed

• Fluent in Dutch and English (written and spoken)

• Senior:  5 years experience in the Pharmaceutical industry

• Thorough knowledge of pharmaceutical legislation, cGMP regulations and guidelines in the area of system qualification

• Knowledge of the different systems used during the manufacturing process

• Strong analytical thinking, risk assessment and communication skills.

• Collaboration and teaming skills

• Mindset for innovation and optimization

Specific know how of systems

• Comet system for incident handling / control of change

• eStream: computerized maintenance management system

• TrüVault: document management system

• Summit (training system)

• Kneat

benefits

This role offers a very competitive hourly rate. This contract will run until initially the end of 2026 and has a strong chance of 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.

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”.