Overview
On Site
Full Time
Skills
Software Development Methodology
Documentation
Traceability Matrix
Budget
Collaboration
Biotechnology
Chemical Engineering
Computer Engineering
Computer Science
Biology
Management
Computerized System Validation
Good Manufacturing Practice
Pharmaceutics
GAMP
Data Integrity
Fluency
English
Data Processing
Manufacturing
Job Details
Responsibilities:
- Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP).
- Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems.
- Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program.
- Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives.
- Collaborate and align with other Diosynth Biotechnologies sites.
- Coordinate with Computer System vendors as needed.
- Opportunities to make periodic International and Domestic travel Requirements.
- Bachelor's degree in chemical engineering, Computer Engineering, Computer Science, Biological Science, or technical equivalent.
- 5+ years' direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations.
- Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11.
- Working knowledge of Kneat validation software is a plus.
- Excellent oral and written communications skills and fluency in English.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
- Knowledge with Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM) would be beneficial.
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