Master Batch Record (MBR) Designer – Latam & Europe (Belgium, Spain)
We are looking for Bilingual candidates fluent in English and one or more of the following languages: Spanish, French, English or Portuguese. This role requires effective written and verbal communication skills to support global operations. The MBR Designer bridges technical documentation, process optimization, and quality assurance to support efficient and compliant production.
Location(s): Belgium, Spain & Latam. Remote, with potential periodic travel (<10%) to client site (s), as needed.
Job Description
The Master Batch Record (MBR) Designer is responsible for developing, maintaining, and optimizing batch records to ensure compliance with pharmaceutical manufacturing standards, Good Manufacturing Practices (GMP), and regulatory requirements.
Key Responsibilities
- Design & Development
- Create and maintain electronic and paper-based Master Batch Records for pharmaceutical manufacturing processes.
- Collaborate with process development, quality assurance, and production teams to ensure batch records accurately reflect manufacturing procedures and regulatory standards.
- Compliance & Quality Assurance
- Ensure MBRs comply with FDA, EMA, and other regulatory requirements.
- Regularly review and update MBRs to reflect process changes or new regulatory guidance.
- Support internal and external audits by providing documentation and resolving issues related to batch records.
- Process Optimization
- Identify opportunities to streamline MBR creation and execution processes, leveraging digital tools like electronic batch record systems.
- Work with cross-functional teams to implement process improvements while maintaining compliance.
- Training & Support
- Train production and quality personnel on MBR use and updates.
- Provide troubleshooting and support during manufacturing deviations or investigations.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
- 3–5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with exposure to batch record development.
- Minimum 2-3 years of hands-on experience with electronic batch record (EBR) systems (e.g., Required: Koerber PAS-X; Preferred: Emerson Syncade, Tulip, Pharma Suite, Master Control, Siemens).
- Proven experience mapping business processes (Required: Visio or Lucid Chart)
- Knowledge of GMP, FDA 21 CFR Part 11, and other relevant regulatory standards.
- Practical experience working in a project environment with a project team.
- Ability to travel internationally.
- Proficiency in EBR/MES platforms and strong technical aptitude for digital tools.
- Familiarity with pharmaceutical manufacturing processes, such as sterile manufacturing, oral solid dosage, or biopharmaceuticals.
- Strong documentation skills with a focus on accuracy and clarity.
- Proficient in the interpretation of process flow diagrams, equipment specifications, and SOPs.
- Exceptional attention to detail and organizational skills.
- Strong interpersonal and communication skills to work eAectively with cross functional teams.
Nice to Have
- MES platform-based training or certification (e.g., PAS-X Training).
Key Competencies
- Compliance-Oriented: Deep understanding of GMP and regulatory requirements.
- Process Knowledge: Familiarity with pharmaceutical production workflows and equipment.
- Technology Proficiency: Skilled in EBR systems and comfortable with evolving manufacturing technologies.
- Collaborative: Effective in working across departments, including QA, production, and IT.
- Proactive: Identify the issue, prepare options, come with a proposal.
What We Offer
- Remote/hybrid work options.
- Opportunities for professional growth and development.
- A collaborative and inclusive work environment.
- The chance to work on impactful projects with a talented team.
- Excellent compensation in USD.
- Hardware and software setup.
Job Features
Job Category | MBR Designer |
Type | Remote/Hybrid |