CSV Engineer / Senior CSV Engineer - Remote and Onsite Opportunities in Singapore

Company Overview

Advanced Manufacturing Tech Solutions (AMTSOL) is a prominent leader in Life Science Manufacturing Technology solutions, committed to fostering business growth through a dedicated and dynamic workforce.

Available Positions

• CSV Engineer based onsite in Singapore requiring 2 to 3 years of relevant experience
• Senior CSV Engineer for remote projects requiring a minimum of 6 years of experience
• Lead/Senior CSV Engineer available remotely, demanding over 9 years of experience

Role Overview

We are actively recruiting CSV Engineers across different seniority levels to participate in validation processes within GMP-regulated pharmaceutical settings. Positions are open for engineers working onsite in Singapore or senior-level professionals involved in remote global assignments.

Core Responsibilities

• Carry out Computerized System Validation lifecycle tasks, including work on MES, automation systems, laboratory, and equipment applications.
• Develop and perform Equipment Qualification protocols (IQ, OQ, PQ) alongside system validation documentation.
• Create, evaluate, and give final approval to validation protocols, testing scripts, and compliance documentation.
• For senior positions, spearhead and oversee CSV and Computerized System Quality Validation strategies, also managing deviation and change control processes.
• Work collaboratively with Quality Assurance, Engineering, and Operations teams to guarantee adherence to GMP and regulatory standards.
• Provide mentorship to less experienced engineers and lead cross-functional validation groups for senior and lead roles.
• Make use of electronic validation solutions such as Kneat to implement paperless validation workflows.
• Remote-based engineers are expected to autonomously handle assignments, timelines, and stakeholder communication without direct onsite oversight.

Qualifications and Requirements

CSV Engineer (Singapore - 2 to 3 years experience)

• Bachelor's degree in Engineering, Computer Science, or a closely related field.
• Between 2 and 3 years of experience in CSV or validation activities within pharmaceutical or life sciences industries.
• Knowledgeable about GMP regulations, FDA 21 CFR Part 11, and the GAMP 5 guidelines.
• Preferred experience with MES validation, automation, or laboratory systems.

Senior CSV Engineer (Remote - minimum 6 years experience)

• Holding a Bachelor’s or Master’s degree in Engineering, Computer Science, or related disciplines.
• A minimum of 6 years dedicated experience in pharmaceutical or life sciences CSV roles.
• In-depth understanding of GMP compliance, GAMP 5, and international regulatory frameworks.
• Proven skills in validating MES, automation, lab systems, and equipment qualification.
• Capability to operate remotely with minimal supervision.

Lead/Senior CSV Engineer (Remote - over 9 years experience)

• Bachelor’s or Master’s qualification in Engineering, Computer Science, or related fields.
• At least 9 years of CSV experience with significant leadership duties.
• Track record of successfully managing validation teams and complex projects internationally.
• Exceptional skills in stakeholder coordination, documentation, and leadership.
• Excellent self-management skills and accountability, particularly for remote work settings.