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
