Specialist, MSEO Manufacturing Systems Validation
Listed on 2025-12-27
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IT/Tech
Systems Engineer, IT Consultant, Systems Analyst
Minimum 50% onsite required
The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works.
The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but not limited to applicable health authority regulations.
REQUIRED COMPETENCIES:Knowledge, Skills, and Abilities:
CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
Bachelor's degree in a life sciences, engineering or technology discipline required.
Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
An equivalent combination of education, experience and training may substitute.
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