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Job Requirements of Manufacturing Systems Validation Specialist:
-
Employment Type:
Contractor
-
Location:
Summit, NJ (Onsite)
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Manufacturing Systems Validation Specialist
Careers Integrated Resources Inc
Summit, NJ (Onsite)
Contractor
Job Title: Manufacturing Systems Validation Specialist
Job Location: Summit, NJ
Job Duration: 6 Months
Job Description
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education and Experience:
Job Location: Summit, NJ
Job Duration: 6 Months
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.
- 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 no limited and applicable health authority regulations.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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
Education and Experience:
- 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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