Validation Engineer

Job Description & Requirements

Job Description:

• Completing work assignments as specified by the Validation Project Manager
• Providing timely updates to the Validation Project Manager
• Adhering to the proper site safety practices; wearing adequate safety equipment when required
• Completing timesheets and expense reports in a timely manner
• Working in a biotech/pharmaceutical environment as a consultant/contractor to various clients of PSC
• Working closely with client's employees on various projects and various GMP facilities to help client with validation issues
• Learning new ideas, techniques and systems
• Commuting to PSC clients' sites for validation projects
• Keep client's proprietary information confidential
• Writing Validation Protocols such as IQ, OQ and PQs
• Executing Validation Protocols such as IQ, OQ and PQs
• CalibratingThermocouples for Temperature Mapping Studies
• Calculating and interpreting of collected data from validation studies
• Generating Validation Summary Reports and Standard Operating Procedures (SOPs)
• Create Validation Risk Assessments

Requirements:

• Degree in Chemical Engineering or equivalent
• Knowledge in GMP facilities and cGMP requirements
• Miniumum 2 years of GMP experience in a biotch or sterile pharmaceutical manufacturing environment, or its equivalent
• Proficient in computer skills and MS Office applications
• Knowledge in process control systems (PLC, DCS and/or SCADA) and validation test instrument such as Kaye Validator, will be an added advantage
• High energy and attention to details
• Excellent written and verbal communication skills
• A demonstrated ability to work well in a team environment
• Well presented
• Must be comfortable with contract basis