Manufacturing Systems Validation Specialist - Careers Integrated Resources Inc

Job Title: Manufacturing Systems Validation Specialist

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