Validation Engineer

PSC BIOTECH PTE. LTD.; Singapore; On-site; SGD 67,000 - 134,000; Part time

Job summary

PSC BIOTECH PTE. LTD. is seeking a contract-based Validation professional in Singapore to support multiple client projects in GMP facilities.

You will perform IQ/OQ/PQ executions, generate protocols and risk assessments, and ensure data integrity and regulatory compliance. Applicants should have a chemical engineering degree, 2+ years GMP experience, and strong communication skills. This role requires field work at client sites and close collaboration with client teams, with strict adherence to

Qualifications

• Degree in Chemical Engineering or equivalent.
• Knowledge in GMP facilities and cGMP requirements.
• Minimum 2 years of GMP experience in a biotech 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.

Responsibilities

• 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

Skills

GMP / cGMP knowledge

Communication skills

Teamwork

Attention to detail

MS Office proficiency

Contract-based work attitude

Education

Chemical Engineering degree or equivalent

Tools

Kaye Validator

PLC/DCS/SCADA knowledge

Job description

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