Senior Validation Engineer

PSC BIOTECH PTE. LTD.; Singapore; On-site; SGD 78,000 - 123,000; Part time

Job summary

PSC Biotech PTE. LTD. seeks a qualified validation contractor to support multiple client projects in biotech/pharmaceutical settings.

You will execute IQ/OQ/PQ protocols, calibrate instruments, and prepare validation reports under the guidance of the Validation Project Manager. You will work on-site at PSC clients' facilities, ensure compliance with GMP/cGMP, and maintain clear communication with client teams.

Qualifications

• Degree in Chemical Engineering or equivalent.
• Knowledge of GMP facilities and cGMP requirements.
• Attention to detail and ability to work in a team.
• Excellent communication skills (written and verbal).

Responsibilities

• Complete work assignments as specified by the Validation Project Manager.
• Provide timely updates to the Validation Project Manager.
• Adhere to site safety practices and wear required PPE.
• Prepare timesheets and expense reports promptly.
• Work in biotech/pharmaceutical environments as a consultant to PSC clients.
• Collaborate with client staff on validation projects across GMP facilities.
• Write and execute IQ, OQ, and PQ validation protocols.
• Calibrate thermocouples for temperature mapping studies.
• Analyze data from validation studies and generate summaries and SOPs.
• Create validation risk assessments.

Skills

Attention to detail

Excellent written and verbal comms

Teamwork

MS Office proficiency

Problem solving

Education

Degree in Chemical Engineering or equivalent

Tools

Kaye Validator

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 6 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