CSV Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Join a leading consulting firm as a CSV Engineer, responsible for managing validation activities for computer systems in compliance with cGMP standards. You will work closely with high-caliber industry specialists, contributing to significant projects with major pharmaceutical companies. This role offers a chance for professional development and comprehensive health benefits in the thriving life sciences sector.

Benefits

Annual leave benefits

Full Health coverage

Training and Development allowance

Qualifications

• Degree in Science or Engineering or related qualifications required.
• 5 years experience in Computerized System Validation (CSV) and relevant regulations.
• Familiarity with cGMP and GDP standards is essential.

Responsibilities

• Manage all computer systems validation activities and ensure compliance with cGMP standards.
• Conduct deviation investigations and manage corrective and preventative actions.
• Collaborate with validation and tech support teams across sites.

Skills

Computerized Systems Validation

cGMP

GDP

Deviations Investigation

Education

Degree in Science or Engineering

Job description

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Position: CSV Engineer

Job Description:

We are currently expanding our team and are looking for a CSV Engineer to support projects on site with a client.

In summary, you will be responsible for managing all computer systems validation activities including, but not limited to, drafting, reviewing, and approving all CSV-related activities, as well as conducting deviation investigations, and working alongside the teams that provide QA oversight to ensure consistent compliance of cGMP standards.

Key Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Collaborate with validation and tech support teams in other sites to ensure a consistent and cohesive approach.
• Conduct deviation investigations, identification and completion of corrective and preventative actions.
• Supervise contractors, engineers and provide day to day support to operations including, modifications and changes to processes and equipment, and troubleshooting activities.
• Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.
• Perform assessment of vendor documents for CSV deliverables.
• Analyse business trends, and propose solutions to issues that can potentially impact the validation status of GMP equipment.

Requirements:

• Degree in Science or Engineering or any other related qualifications.
• Familiar with government code of practice, regulations, current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP).
• At least 5 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

What’s In It for You?

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

What's Next?

If you are interested in applying for this position, please send an email to [e-mail].

Coalesce Management Consulting 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.