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