Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Electronic Batch Record (EBR) Qualification Specialist

Job Summary:

The EBR Qualification Specialist plays a critical role in the design, development, implementation, and validation of Electronic Batch Record systems within a pharmaceutical manufacturing environment. This position ensures that EBR systems are compliant with regulatory requirements (e.g., FDA, EMA, GMP), accurately represent batch processing activities, and enhance operational efficiency. The specialist collaborates with cross-functional teams to ensure seamless integration of EBR systems into manufacturing processes.

Key Responsibilities:

1. EBR Design and Configuration:

• Develop and configure electronic batch records to reflect manufacturing processes and regulatory requirements.

• Work closely with manufacturing, quality assurance, and IT teams to gather user requirements and translate them into functional EBR solutions.

2. System Validation:

• Lead or support validation activities (e.g., IQ, OQ, PQ) for EBR systems, ensuring compliance with GMP, 21 CFR Part 11, and other relevant regulations.

• Develop and execute validation protocols and reports for EBR systems.

3. Testing and Troubleshooting:

• Conduct system testing, including unit testing, integration testing, and user acceptance testing (UAT), to ensure the functionality and reliability of the EBR system.

• Identify and resolve issues or discrepancies in EBR workflows, ensuring accuracy and consistency in batch documentation.

4. Compliance and Documentation:

• Ensure that all EBR processes comply with regulatory requirements and internal quality standards.

• Maintain accurate and up-to-date documentation, including validation records, change control requests, and system configurations.

5. Training and Support:

• Provide training to end-users on the functionality and use of EBR systems.

• Act as a point of contact for troubleshooting, issue resolution, and system support.

6. Continuous Improvement:

• Identify opportunities to optimize and enhance EBR systems and associated workflows.

• Stay updated on industry trends and advancements in EBR technology and regulatory expectations.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 3-5+ years of experience in EBR implementation, validation, or a similar role within the pharmaceutical/biotechnology industry.
• Strong knowledge of GMP, 21 CFR Part 11, and other regulatory guidelines for computerized systems.
• Proficiency with EBR platforms (e.g., Werum PAS-X, Emerson Syncade, or similar).
• Experience with validation documentation (IQ/OQ/PQ) and change control processes.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively with cross-functional teams in a fast-paced environment.

Preferred Skills:

• Experience with Manufacturing Execution Systems (MES) and integration with other enterprise systems (e.g., ERP, LIMS).
• Familiarity with risk-based validation approaches (e.g., GAMP5).
• Knowledge of pharmaceutical manufacturing processes and batch record requirements.