Specialist, MSEO Manufacturing Systems Validation
3 weeks ago
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: Specialist, MSEO Manufacturing Systems Validation
Location: Summit, NJ
Duration: 6 months
Pay rate: $55 to $57 W2 Deal
Job Description:
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.
Roles And Responsibilities:
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
- Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation
- Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR 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
- 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 and Veeva document/change management systems and middleware WebMethods
- With advanced technical document writing and time management skills, including ability to prioritize and manage expectations
- Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
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