Laboratory Systems Specialist

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:
Quality

Job Sub Function:
Quality Control

Job Category:
People Leader

All Job Posting Locations:
Little Island, Cork, Ireland

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

As a Laboratory Systems Specialist you will:

Be at the forefront of delivering outstanding quality through the introduction and support of QC Analytical Instrument Qualification.

You'll lead dynamic projects, coordinate across teams and partners, and drive collaboration that makes a real impact.

This requires an end-to-end mind-set in analytical processes and related computerized systems.

This role will lead, enable, and support projects that deliver a fit for future focus for QC testing while ensuring compliance to digital Data Integrity requirements.

Key Responsibilities:


* Technical owner of QC Equipment Assets & Applications.


* Responsible for the development and execution of a site QC Equipment Lifecycle Management (ELM) Strategy in alignment with Global ELM team.


* Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of analytical instruments in accordance with GMP, GAMP, and company standards.


* Implement and maintain QC Equipment Software Data Integrity standards in line with regulatory requirements (e.g., 21 CFR Part 11, ALCOA+ principles).


* Project management of site QC Equipment introduction, from budget approval to equipment qualification

Qualifications / Requirements:

Third level Degree or equivalent experience in a science or pharmaceutical discipline.


* A minimum of 3 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.


* Proven experience in IQ/OQ/PQ procedures and validation practices.


* A solid understanding of QC equipment and software, including Data Integrity compliance requirements


* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.


* Excellent documentation, communicat...