CQV Engineers-Filling Line/Benchtop Equipments/Facilities & Utilities(Multiple Roles)

PROCESS ENGINEERING SPECIALISTS PTE. LTD.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Process Engineering Specialists in Singapore seeks CQV Engineers to support a range of life sciences projects. You will review and approve C&Q plans, protocols and reports, and provide quality oversight across facilities, utilities and equipment within GMP biopharmaceutical settings.

Leads/seniors/engineers will work through IQ/OQ/PQ lifecycle, validation documents and change controls, ensuring regulatory compliance and orderly project execution.

Qualifications

• Review and Approve C&Q plans/protocols/reports and GxP SOPs/records.
• Provide quality oversight to verify biopharmaceutical GMP plant in facilities, utilities and equipment, control systems, process and computerized systems.
• Review validation life-cycle documents during commissioning, qualification (IQ/OQ) and validation (PQ) phases (pre and post-execution plans and test specs, validation summary reports).
• Ensure documents comply with quality standards and regulatory requirements.
• Review engineering change control to evaluate validation/quality impact.
• Support resolution of validation deviations and approvals.
• Participate in qualification coordination meetings to ensure correct event sequence and compliance.

Responsibilities

• Review and Approve C&Q plans/protocols/reports and GxP SOPs/records.
• Provide quality oversight to verify biopharmaceutical GMP plant in areas facilities, utilities and equipment, control systems, process and computerized systems.
• Review validation life-cycle documents during commissioning, qualification (IQ/OQ) and validation (PQ) phases e.g., pre and post-execution commissioning/qualification plans and test specifications, validation summary reports.
• Ensure that documents are in compliance with quality standards and applicable regulatory requirements.
• Review engineering change control to evaluate the validation/quality impact(s).
• Support in the resolution of validation deviations and approval.
• Participate in the qualification coordination meeting to ensure correct event sequence in compliance.

Skills

CQV experience

Quality oversight

GxP familiarity

Tools

Benchtop equipment

Clean air devices / HVAC

Utilities

Job description

Process Engineering Specialists is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

We are currently looking for CQV Engineers to join us on permanently and to help us deliver various projects in the Life Sciences Industry.

We are looking for the following Leads/Seniors/Engineer:

• Filling line CQV experience (strong preference)
• Benchtop equipment
• Utilities
• Clean air devices / HVAC

Key Attributes/Responsibilities:

• Review and Approve C&Q plans/protocols/report and GxP SOPs/records
• Provide quality oversight to quality and validate biopharmaceutical GMP plant in areas facilities, utilities and equipment, control systems, process and computerized system.
• Review validation life-cycle documents during the commissioning, qualification (IQ/OQ) and validation (PQ) phase e.g., pre and post-execution commissioning/ qualification plans and test specifications, validation summary reports & etc.
• Ensure that documents are in compliance with quality standards and applicable regulatory requirements
• Review engineering change control to evaluate the validation/quality impact(s).
• Support in the resolution of validation deviations and approval.
• Participate the qualification coordination meeting to ensure correct event sequence in compliance.

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.