Senior MES Validation Engineer

Responsibilities

Develop, draft and route for approval overall test scripts, validation protocols and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards.

Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems

Provide input on the validation strategy of the project

Provide guidance on overall test strategy and ensure alignment with existing validated computer systems

Execute formal validation in a GMP environment

• Experience in Rockwell Factory Talk Pharma Suite
• 5 years of experience as a Validation Professional;
  Proven experience in developing and executing validation protocols for computer systems
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation
• Ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices
• A solid understanding of Computerized System Validation (CSV)
• Strong verbal and written communication skills
• Bachelor’s degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or a related life sciences discipline
• (Preferred) Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).
• Experience in managing testing plans and testing execution
• Experience with industry specific tools such as ERP systems, Val Genesis, LIMS, SCADA, and other regulated life sciences platforms.