Job Description

The candidate is responsible for the validation of automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus. In this role, the engineer has to work in accordance with the company's policies and procedures to ensure validation is performed in accordance with quality requirements and regulations.

Responsibilities:

Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Support CSV lead(s) for CSV activities. Prepare, generate all relevant test / qualification protocols and documentations. Perform troubleshooting during test execution. Updating and generating lifecycle documentations. Review validation strategies and plans, and update accordingly. Collaborate with Quality Engineering & Validation (QVCSV) and fellow Validation engineers in driving approvals of qualification / validation documentations and protocols, and handling deviations. Support validation/qualification activities. Any other task as assigned by Supervisor/Manager.

Requirements:

Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls. Min. 1 year' experiences in CSV preferably in a biotech facility preferred. Fresh graduates are welcome to apply. Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) Basic understanding of Computer System Validation principles and GMP and regulatory requirements like GAMP5, ERES and Data Integrity. Involved with some form of validation/qualification efforts of GMP computer systems and IT systems. Knowledge of thermal mapping validation and usage of data logger is a plus. Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams Must be team player, curious with strong analytical and organizational skills
Job Type: Contract
Contract length: 12 months

Pay: $2,500.00 - $4,500.00 per month

Benefits:

Health insurance
Experience:

Validation process: 1 year (Preferred) GMP/GLP: 1 year (Preferred) Pharmaceutical: 1 year (Preferred)
Work Location: In person