Validation - Specialist, MSEO Manufacturing Systems Validation
Summit, NJ
Job Requirements:
- Onsite Requirement: Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with the manager and be available onsite when the manager requests).
- Education: Bachelor's degree required in Life Science or Engineering.
- Duration: 6 months (Possibility of extension for the right candidate).
Job Description:
The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for the 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 work. 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 completed following the relevant Client procedures, such as CSV SOP, and applicable health authority regulations.
Required Competencies: Knowledge, Skills, and Abilities
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE), as well as Recipe Authoring/Validation.
- Ability to work extended hours or a modified work schedule to assist the manufacturing operations support model, including a 12x7 on-call support rotation.
- Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21 CFR Part 11 (electronic records and electronic signatures), and good documentation practices with the ALCOA+ principles of data integrity.
- Familiarity with risk-based approaches to validation and Computer Software Assurance (CSA) principles.
- Understanding the concept of Critical Thinking for Computerized Systems.
- Familiar with the development of CSV documentation:
- Validation Plans
- Requirements
- Design/Configuration Specifications
- Test Scripts (IQ/OQ/PQ/UAT)
- Summary Reports
- Trace Matrices
- SOPs
- Experience with MES infrastructure, ALM, Veeva document/change management systems, and middleware WebMethods.
- Advanced technical document writing and time management skills, including the ability to prioritize and manage expectations.
- Ability to operate effectively and with minimal supervision, whether within a team or independently, performing projects and related duties.
Education and Experience:
- Bachelor's degree in a life sciences, engineering, or technology discipline is required.
- Minimum of 2+ years of relevant work experience, preferably in a pharmaceutical manufacturing environment.
- An equivalent combination of education, experience, and training may substitute.