Validation Lead

Validation Lead - Bio-analytical Digital Transformation and HMD ELN Project - J&J Innovative Medicine & MedTech

Location: Limerick Ireland - Hybrid or remote working 

Duration: Until December 2025 with high chance of extension 

Hours: 40 per week

We are seeking a highly skilled and experienced Validation Lead to support the Bio-analytical Digital Transformation for the Pre-clinical Sciences and Translational Safety (PSTS) department (75%) and Harmonized Medical Device Electronic Lab Notebook (HMD ELN) project. The successful candidate will play a critical role in ensuring compliance with pharmaceutical regulations (GxP) and adherence to Software Development Life Cycle procedures, providing expertise in the implementation of Labvantage platform solutions.

• Bio-analytical Digital Transformation project is a multi-year project, integrating a variety of bio-analytical assays (qPCR, ADA/NAb, PK,…) within the LabVantage platform. The digital transformation project aims to streamline end to end assay execution (LIMS, ELN, Reagent Management, …) within one platform. It supports bio-analytical labs at Spring House (US) and Beerse (BE). This year's focus lies on delivery of ELN functionalities and qPCR assays.

• The HMD R&D LabVantage ELN/LIMS will be utilized by the Global R&D Laboratories of DePuy Synthes, JJ MQSA, and Ethicon to create, record, maintain, and manage primary GxP records in electronic format related to the entire product development testing process. This includes design, development, verification, validation, reliability, fatigue, and durability testing, as well as managing associated electronic signatures. The system will generate reports for test result reporting to support product development activities and will also verify other laboratory activities, such as instrument calibration and preventative maintenance. The system will support multiple sites across the globe.

roles and responsibilities

Compliance & Testing Strategy

• Prepare and maintain Compliance and Testing strategy documents in alignment with Software Development Life Cycle (SDLC) and Computer System Validation (CSV) Standard Operating Procedures (SOPs).

SDLC/QMS Deliverables

• Ensure that all SDLC and Quality Management System (QMS) deliverables for each project release are completed in accordance with the established strategy documents.

User Story Reviews

• Conduct pre-reviews of user stories and coordinate approvals to facilitate project progression.

System Integration Testing (SIT)

• Pre-review SIT outcomes and coordinate necessary approvals, ensuring that all user stories have been thoroughly tested.

User Acceptance Testing (UAT)

• Prepare UAT test scripts and manage approvals to ensure testing aligns with user requirements.

Change Control Management

• Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations.

Impact Assessments

• Conduct impact assessments and manage administrative tasks related to deferred bugs, ensuring proper tracking and resolution.

Document Reviews

• Coordinate periodic reviews and updates for living documents such as the Business Impact Assessment (BIA), and Corrective Action (CA) plans.

Disaster Recovery (DR) Testing

• Facilitate and coordinate annual DR testing to validate system recovery processes.

Quality Management System Documentation

• Update and co-update QMS documents as required, including System Administrator SOPs and User Access Procedures.

Validation Approach Alignment

• Collaborate with the Technical Quality (TQ) team to align on validation approaches for edge case scenarios as necessary.

General Guidance

• Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed.

how to succeed

• Bachelor’s degree in Life Sciences, Engineering, or a related field. An advanced degree is preferred.

• Minimum of 5 years of experience in validation within the pharmaceutical or biotechnology industry, with a strong understanding of compliance regulations.

• Extensive knowledge of SDLC and CSV methodologies.

• Experience with Labvantage or similar laboratory information management systems (LIMS).

• Experience with JIRA, xRAY

• Strong analytical and problem-solving skills.

• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

• Certification in Quality Assurance or Compliance (e.g., CQA, CQP) is a plus.

• Validation experience within J&J is a plus.

benefits

This role offers a very competitive hourly rate. This contract will run until December 2025 and has a strong chance of extension. 

you are welcome here

Johnson & Johnson 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.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

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. 

• The pay rate for this role will depend on how you are paid. 

• PAYE, LTD & Umbrella options are available. 

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”.