Electronic Batch Record Specialist

<p style="text-align:left !important">At Johnson &amp; 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 <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Supply Chain Engineering<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Manufacturing Engineering<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Scientific/Technology<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><div><p><b><span>About Innovative Medicine </span></b><span> </span></p></div><div><p><span><span>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.</span></span><span> </span></p></div><div><p><span><span>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</span></span><span> </span></p></div><div><p><span><span>Learn more at https://www.jnj.com/innovative-medicine</span></span><span> </span></p><p></p><p><b>Overview</b></p></div><p>We are seeking a skilled and detail-oriented eBR (Electronic Batch Record) Specialist to join our team. The ideal candidate will be familiar with the CAR-T process and will demonstrate affinity with PAS-X, a leading Manufacturing Execution System (MES). The eBR Specialist will be responsible for supporting implementation of business requirements into an existing MES application according to regulatory standards and company policies. The Specialist is also responsible to evaluate the impact on the process.</p><p><b>Key Responsibilities:</b></p><ul><li><p>Technical Writing:<b> </b>Master batch records are key documents in manufacturing. They outline the instructions, procedures, and requirements for producing drug products that meet regulatory and quality standards. As a eBR Specialist, you make sure the content of these and other process documents are kept up to date. </p></li><li><p>You will own the CAR-T process knowledge and ensure successful implementation in batch records.<b> </b>You will collaborate with cross-functional teams, including production, quality assurance, and IT, to gather requirements and ensure accurate MBR configuration.</p></li><li><p>You will develop a comprehensive understanding of PAS-X, which will enable you to effectively communicate on technical topics with the MES team.</p></li><li><p>You will continuously improve eBR design and technical processes to enhance efficiency and compliance.</p></li><li><p>In general, this is an administrative role in which you can use scientific insights / knowledge to ensure compliance with GxP.  </p></li></ul><p></p><p><b>Qualifications:</b></p><ul><li><p>Bachelor’s degree in Biotechnology, Chemistry, Engineering, Life Sciences, or a related field.</p></li><li><p>Experience in Tech Writing in the pharmaceutical industry</p></li><li><p>Experience with supply chain systems (SAP, eLIMS, PAS-X MES, …)</p></li><li><p>Knowledge of the CAR-T process is a plus</p></li><li><p>Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.</p></li><li><p>Excellent problem-solving skills, and attention to detail.</p></li><li><p>Ability to work collaboratively in a team environment.</p></li><li><p>Strong communication and interpersonal skills.</p></li></ul><p></p><p>At Johnson &amp; Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.</p><p></p><p><b>Here’s what you can expect:</b></p><p></p><ul><li><b>Application review: </b>We’ll carefully review your CV to see how your skills and experience align with the role.</li><li><b>Getting to know you: </b>If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.</li><li><b>Staying informed: </b>We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.</li><li><b>Final steps: </b>For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.</li></ul><p>                                                                                                                                         </p><div><p>Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson &amp; Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA</p></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Accelerating, Analytical Reasoning, Coaching, Communication, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Schedule, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy