Job Description:
Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with manager and be available onsite when manager requests)
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.