Lab Instrument Qualification Engineer
il y a 5 jours
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: Beerse, 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 Lab Instrument Qualification Engineer to 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 qualification activities, providing constructive feedback and support to promote continuous improvement. * Participate in audits and regulatory inspections as the domain expert, ensuring that all qualification documentation and activities are thorough and compliant. * Know the latest with advancements in laboratory instrumentation technology and relevant regulations to provide informed guidance to contractors Qualifications / Requirements: * You acquired a Bachelor or Master's degree or equivalent experience in Engineering, Biological Sciences, Chemistry, or a related field. * Experience * Minimum of 5 years of experience in laboratory instrument qualification or a related role within a regulated environment * Preferably a proven track record of coaching and/or leadership * Strong understanding of GMP regulatory standards and quality systems * Excellent analytical, problem-solving, and organizational skills. * In-depth knowledge of a wide variety of analytical techniques (LC, GC, dissolution, NIR, …) Knowledge, Skills & Capabilities * You have excellent analytical, problem-solving, and organizational skills. * You have desire to make a difference and achieve results.
Your analytical skills help you to understand difficult issues and related business needs. * You can take decisions and can deal with various issues and projects simultaneously. * You are passionate about bringing innovative ideas * Strong communication and negotiation skills, with the ability to communicate clearly and appropriately to all levels of the organization in both written & oral forms. Other: * You will be part of a small but enthusiastic and inclusive team in an innovative environment that values personal and professional development In this role, you will have the potential to transform both our business and your career.
Through on the job training, e-learning, various projects and programs, we ensure personal growth by focusing on your talents and empower you to take control over your career and where it takes you. * Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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