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Full-time
bachelor degree, postgraduate degree
Posted 1d ago
~40 hrs/week
Remote in Singapore
Responsibilities
Execute Computerized System Validation (CSV) lifecycle activities including equipment qualification and validation documentation across various systems. Lead validation strategies, manage cross-functional teams, and ensure adherence to GMP and global regulatory compliance frameworks.
Requirements
Requires a Bachelor's or Master's degree in Engineering or Computer Science with significant experience in CSV and pharmaceutical validation. Candidates must possess strong knowledge of GMP, GAMP 5, and regulatory standards, with leadership capabilities for senior roles.
Full job description
AMTSOL:
A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Job Titles:
CSV Engineer (Onsite, Singapore – 2–3 Years Experience)
Senior CSV Engineer (Remote – 6+ Years Experience)
Lead/Senior CSV Engineer (Remote – 9+ Years Experience)
About the Roles
We are hiring CSV Engineers at multiple levels to support validation activities in GMP‑regulated pharmaceutical environments. Opportunities are available for onsite engineers in Singapore and senior professionals working remotely on global projects.
Key Responsibilities
Execute Computerized System Validation (CSV) lifecycle activities across MES, automation, lab, and equipment systems.
Perform Equipment Qualification (IQ/OQ/PQ) and system validation documentation.
Author, review, and approve validation protocols, test scripts, and compliance reports.
Lead and manage CSV/CQV strategy for senior roles, including deviation/change control.
Collaborate with QA, Engineering, and Operations teams to ensure GMP and regulatory compliance.
Mentor junior engineers and manage cross‑functional validation teams (senior/lead levels).
Utilize e‑validation tools (e.g., Kneat) for paperless validation workflows.
Remote roles: Independently manage deliverables, deadlines, and stakeholder communication without direct onsite supervision.
Requirements
CSV Engineer (Singapore – 2–3 Years)
Bachelor’s degree in Engineering, Computer Science, or related discipline.
2–3 years of CSV/validation experience in pharma or life sciences.
Familiarity with GMP, FDA 21 CFR Part 11, and GAMP 5.
Exposure to MES validation, automation systems, or lab systems preferred.
Senior CSV Engineer (Remote – 6+ Years)
Bachelor’s/Master’s degree in Engineering, Computer Science, or related discipline.
6+ years CSV experience in pharma/life sciences.
Strong knowledge of GMP, GAMP 5, and global compliance frameworks.
Proven expertise in MES validation, automation validation, lab system validation, and equipment qualification.
Ability to work remotely with minimal supervision.
Lead/Senior CSV Engineer (Remote – 9+ Years)
Bachelor’s/Master’s degree in Engineering, Computer Science, or related discipline.
9+ years CSV experience with leadership responsibilities.
Demonstrated success in managing validation teams and complex global projects.
Excellent stakeholder management, documentation, and leadership skills.
Strong self‑management and accountability in remote settings.
Related keywords
CSVComputerized System ValidationGMPFDA 21 CFR Part 11GAMP 5MESAutomationLab SystemsEquipment QualificationIQOQPQValidation ProtocolsComplianceKneatLife Science
Delivering innovation through technology for Life Science manufacturing!
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2022
Headquarters
Singapore
LinkedIn followers
3,867
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization, helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation, Manufacturing Execution Systems (MES), OT Networking and Digital Technologies.
Offices: Singapore, SG · Cork, IE · Pune, IN · Dover, DE, US
How many Healthcare jobs are open in Singapore, Singapore right now?
There are currently 968 open healthcare positions in Singapore, Singapore listed on Clera. New openings are added daily as companies post roles.
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Companies currently hiring include SingHealth, Thermo Fisher Scientific, GSK, National Institute of Education, Singapore, Sanofi, among others. Browse the listings above to see every active employer.
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