QC Engineer Lab Instruments

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at a QC Engineer Lab Instruments:

Within Johnson & Johnson Innovative Medicine Supply Chain we are recruiting a QC Engineer Lab Instruments (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel Belgium.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Supply Chain Quality (IMSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

You will be part of our enthusiastic QC Lab support team that has a strong quality focus on lab instrument qualification/validation automation and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training e-learning implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers additional pension plan and hospitalization insurance.

If this excites you and youre ready for a new challenge this is your chance!

The responsibilities and the impact YOU will have:

Reporting to the Lab Support QC Manager the QC Engineer Lab Instruments main responsibilities include:

• As a technical expert you are responsible for a wide range of techniques related to laboratory instruments. You serve as the point of contact for the implementation of new lab instruments and associated software ensuring that all required documentation complies with applicable regulations.
• You act as a knowledge owner for lab instrument management and provide technical training and input.
• You define test specifications and independently prepare reports related to equipment management such as Periodic reviews system audit trail reviews trend reports Validation Master Plan backup and restore activities etc.
• You review and approve instrument qualification documents such as URS IOPQ setup documents Part 11 Annex 11 etc.
• You have knowledge on the set-up of computerized systems and have regular connects with IT. You will develop into a Business Administrator for our laboratory systems.
• You assess and deploy new lab technologies (e.g. Labotica automated robotic systems) in the Geel QC Lab to boost efficiency for highvolume testing.
• You help monitor the qualification planning of laboratory instruments taking into account the needs of our dynamic launch and growth site.
• You have in-depth expertise in data integrity and contribute to assessments and the local implementation of global guidelines.
• You lead and support various departmental projects within QC.
• You oversee the work of external partners involved in the installation testing maintenance calibration and qualification of laboratory instruments.
• You conduct root cause analyses in case of deviations and provide recommendations for solutions and improvements.
• You analyse instrument trends and collaborate with experts and global teams to define and implement improvement initiatives aimed at instrument optimization and continuous improvement.
• You stay up to date with relevant developments in laws and regulations and translate them into new working methods procedures and potential investments.
• You support audits and inspections within your area of expertise.

We would love to hear from YOU if you have the following essential requirements:

Education:

• You hold a masters degree in a scientific field or have at least 5 years of relevant experience.

Experience & Skills

• Technologically proficient with knowledge of automation IT and digital applications.
• Experience in developing Lab instrument qualification documents (URS IOPQ etc.) with strong attention to compliance.
• Strong sense of responsibility with the ability to lead coordinate and take initiative when needed.
• Hands-on mentality with excellent problem-solving skills.
• Accurate results-oriented and independent with strong organizational and planning skills.
• Comfortable working in a dynamic environment where priorities can shift rapidly.
• Strong communication skills a team player and proactive in taking initiative.
• Ability to work in a highly regulated international environment.
• Fluent in Dutch and English (both written and spoken).
• Familiarity with cGMP regulatory requirements risk assessment data integrity and industry best practices.
• Knowledge of quality systems (Comet ELIMS TruVault etc.) is a plus.

Other:

- As a QC Engineer Lab Instrument Qualification you will work in day shifts.

Required Skills:

Preferred Skills: