Biopharma - Lab Equipment Qualification Engineer

PROCESS ENGINEERING SPECIALISTS PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading international services provider in Singapore is looking for skilled individuals to develop and execute validation documents for projects in the pharmaceutical sector. Responsibilities include commissioning new technologies and collaborating with various functions. The ideal candidate should have experience in validation documentation and strong analytical skills to manage deviations. This position promises exciting challenges in a multinational environment.

Qualifications

• Experience in developing and executing validation documents.
• Ability to commission and validate new technologies.
• Familiarity with computerised systems and regulatory requirements.

Responsibilities

• Develop and execute validation documents such as URS, IQs, OQs, PQs, QPs, QRs.
• Commission and validate Group C equipment.
• Participate in investigations of deviations and conduct analyses.

Skills

Validation documentation development

Commissioning and validation of equipment

Analytical skills for deviation investigations

Collaboration across functions

Knowledge of 21 CFR Part 11

Job description

PES 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.

Responsibilities

• Develop and execute validation documents, including URS, IQs, OQs, PQs, QPs, QRs, audit trail reviews, and supplier ERES.
• Commission and validate new technologies and equipment; Group C equipment in specific
• Participate in investigations of deviations, conduct analyses, and assess changes.
• Collaborate with multiple functions to organize, plan, and facilitate smooth qualification activities.
• Experience working with computerised systems and knowledge of 21 CFR Part 11

We are currently looking for candidates in Singapore.

If you would like to find out about this opportunity or any other opportunity, please forward your CV to Sruthi Srikanth ([e-mail]).

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