Job Description :
Pay Range $59hr - $61hr
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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