Electronic Batch Record Specialist

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.

Key Responsibilities:

• Technical Writing: 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.
• You will own the CAR-T process knowledge and ensure successful implementation in batch records. You will collaborate with cross-functional teams, including production, quality assurance, and IT, to gather requirements and ensure accurate MBR configuration.
• You will develop a comprehensive understanding of PAS-X, which will enable you to effectively communicate on technical topics with the MES team.
• You will continuously improve eBR design and technical processes to enhance efficiency and compliance.
• In general, this is an administrative role in which you can use scientific insights / knowledge to ensure compliance with GxP.

Qualifications:

• Bachelor’s degree in Biotechnology, Chemistry, Engineering, Life Sciences, or a related field.
• Experience in Tech Writing in the pharmaceutical industry
• Experience with supply chain systems (SAP, eLIMS, PAS-X MES, …)
• Knowledge of the CAR-T process is a plus
• Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
• Excellent problem-solving skills, and attention to detail.
• Ability to work collaboratively in a team environment.
• Strong communication and interpersonal skills.

Preferred Skills:

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

Location: Gent or Beerse 
Hybrid Work