Key Skills

Job Description

Data Integrity / CSV engineer Location: Leiden, The Netherlands (Hybrid working - min of 3 days onsite, 2 remote) Duration: 12 months Hours: 40 Imagine your next project taking a lead role in data integrity and computer system validation to shape control strategies and drive GxP compliance in a complex, highly regulated manufacturing environment. roles and responsibilities As part of a Site DI project core team member, lead and facilitate data process flow mapping (D/PFM) sessions for equipment located in the manufacturing area (analytical, manufacturing, execution systems) followed by data risk assessment meetings with stakeholders such as business & technical system owners. Key role in designing short control strategies and long-term plans for any noncompliant equipment which can be accepted by the business and the quality & compliance unit Create the data risk assessment reports and coordinate the timely review & approval of the reports Performs and analyses data integrity gap assessments and proposes remediations (technical, procedural, training), coordinating activities and stakeholders to lead to full gap remediation. Collaborate with Business System Owners, Technical System Owners, QA and Training to identify the most efficient action to be taken for any system and at any step of the data flow Analyses data integrity gaps and leads activities toward remediation Improves the procedural framework related to DI topics Guides Business System Owners and Technical System Owners in meeting current and preparing for future expectation of Data Integrity Manages work according to a schedule how to succeed Strong, up-to-date knowledge of computerised systems, data integrity principles, and GxP compliance, including current regulatory expectations (e.g., FDA, EMA, MHRA guidance). Understands both technical and procedural requirements of Data Integrity in manufacturing and analytical environment Proven ability to apply independent judgment and decision-making to develop sound solutions that balance structural, regulatory, and business needs. 4–6 years of experience in the pharmaceutical or life sciences industry, with a focus on data integrity, quality systems, or validation. Hands-on experience with global, complex, and highly regulated environments, preferably in a multinational organisation. Familiarity with risk-based approaches, audit trail reviews, and electronic record/electronic signature compliance. Strong understanding of CSV (Computer System Validation) and ALCOA+ principles. Decisive, pragmatic and persevering with a can-do mentality. benefits This role offers a very competitive hourly rate. This contract will run for Minimum of 1 year 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 Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 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 or LinkedIn InMail - you must apply direct to this advert. 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”.

Core Responsibilities

Lead data process flow mapping and risk assessment activities for manufacturing and analytical systems, and develop control strategies for noncompliant equipment. Assess data integrity gaps, coordinate technical, procedural, and training remediations, and guide system owners in meeting regulatory expectations.

Requirements

Requires 4–6 years of pharmaceutical or life sciences experience focused on data integrity, quality systems, or validation, with knowledge of computerized systems, GxP, CSV, and ALCOA+ principles. Candidates should have experience in complex regulated environments and familiarity with risk-based approaches, audit trail reviews, and electronic records and signatures compliance.