Validation Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Town of Islip (NY); On-site; USD 70,000 - 95,000; Full time

Job summary

A leading consulting firm is expanding its Life Sciences Division and seeking a Validation Engineer. The role involves reviewing validation protocols, managing compliance activities, and working with cross-functional teams on high-end projects. This position offers competitive benefits, including travel, medical coverage, and opportunities for professional development.

Benefits

Travel coverage

Medical coverage

Annual leave options

Training and development allowances

Qualifications

• Experience in validation engineering and compliance required.
• Strong understanding of validation protocols and regulations.
• Ability to work in cross-functional teams and communicate effectively.

Responsibilities

• Review computer system validation protocols and reports.
• Ensure compliance of validation activities with company standards.
• Conduct risk assessments and manage validation deliverables.

Skills

Computer System Validation

Risk Assessment

Regulatory Compliance

Quality Management

Education

Degree in Life Sciences or related field

Job description

We are currently expanding our team within our Life Sciences Division and are looking for a Validation Engineer to support projects on-site with a client. The key responsibilities include:

1. Review and approval of computer system validation protocols and reports.
2. Preparation and management of CSV deliverables for laboratory instruments, manufacturing equipment, utility systems, IT, and enterprise systems.
3. Ensure the Computer System Validation aligns with the Validation Master Plan for Computer Systems.
4. Ensure timely completion of all validation activities, including computer systems, equipment, utilities, and facilities, with compliance.
5. Assess vendor documents for CSV deliverables.
6. Conduct risk assessments to identify potential risks with computerized systems, such as data integrity, security, and regulatory compliance.
7. Prepare and review standard operating procedures to maintain the organization's quality system.
8. Participate in cross-functional team (CFT) meetings related to IT systems and ensure completion of pending actions.
9. Review IT applications and systems periodically and compile reports.

What’s in it for you?

Our benefits include travel, medical coverage, and annual leave options, in addition to your base salary. We also offer training and development allowances aligned with our values of growth and helping people grow. You will have the opportunity to work with world-class teams delivering high-end projects for leading global businesses.

Coalesce Management Consulting is an equal opportunity employer. We do not discriminate based on age, race, religion, sexual orientation, or any other factors unrelated to employment skills. We welcome applications from candidates of all backgrounds for this role.