Sr Analyst Lab Ops - Lab Instrument Qualification Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Laboratory Operations

Job Category:
Professional

All Job Posting Locations:
Turnhout, Antwerp, Belgium

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for Sr Analyst Lab Ops - Lab Instrument Qualification Engineerto be in Beerse.

Purpose:

Within Discovery, Product Development & Supply, the Strategy & Operations team within Therapeutics Developments & Supply has an open position for a Lab Instrument Qualification Engineer.

We are looking for an experienced engineer that will act as a subject matter expert and guide for our contractors involved in lab instrument qualification.

This role is critical in ensuring that all qualification efforts meet industry standards and regulatory requirements while providing mentorship and support to contractors implementing qualification activities.

You will be responsible for:


* As the Lab Instrument Qualification engineer, you are supporting our team in (i) initial qualification of new instruments, (ii) periodic qualification, and (iii) management of quality documents.


* You will serve as the primary expert on laboratory instrument qualification practices, providing coaching and guidance to contractors to ensure compliance with regulatory standards and best practices.


* You will support the development & maintenance of comprehensive qualification protocols and communicate these effectively to contractors.


* Review and approve qualification documentation prepared by contractors, including Standard Operating Procedures (SOPs), test plans, and qualification reports, ensuring alignment with organizational and regulatory criteria.


* Lead training sessions and workshops for contractors to enhance their understanding and execution of qualification processes.


* Collaborate with internal teams, including Quality Assurance and Labs, to align contractor work with operational standards and regulatory requirements.


* Conduct regular assessments of contractor qualif...