Roles & Responsibilities
The Opportunity
Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.
Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.
Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.
Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated / cell-based meat to FSSC 22000 and by a competent food regulatory body.
We are first in the region to operate an end-to-end integrated full cell line creation / immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.
The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.
Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.
Esco Aster.
One World Biosolutions for One Health.
The Scope
The candidate will be a member of the Systems and Infrastructure team that manages Servers, System, PaaS and SaaS.
Primary work location : Ayer Rajah Crescent, Singapore.
Responsibilities
- Manage user access controls, change management processes, and periodic reviews for GMP-related IT systems.
- Draft, review, and maintain IT-related Standard Operating Procedures (SOPs) and Policies in compliance with GMP and regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11).
- Ensure electronic data from GMP systems are securely backed up and retained in accordance with approved SOPs, policies, and data integrity principles (ALCOA+).
- Implement and maintain systems and services across all environments in accordance with Company standards and policies.
- Review or propose remediation solutions to address vulnerabilities identified and ensure the solutions are implemented within reasonable timeframe.
- Manage, coordinate, and implement software / system upgrades and patches.
- Provide remote and onsite support to all computer users.
- Execute daily tasks including hardware maintenance, backup status check, support and optimized key functional areas such as network, server, data communication, telecommunications system and security.
- Participate in all infrastructure improvement activities.
- Ensure proper IT infrastructure policies, standards, procedures and risk controls are followed during issues resolution.
- Track and respond to deviations, incidents, and CAPAs related to IT systems.
- Coordinate with cross-functional teams (Quality, Manufacturing, R&D, etc.) to implement and maintain compliant IT solutions. Participate in computer system validation (CSV) activities including system assessments, risk analysis, and documentation of validation deliverables.
- Monitor and maintain the GxP system infrastructure, ensuring high availability, security, and performance of critical systems.
Requirements
Diploma or Bachelor’s Degree in related discipline.Experience in Azure cloud and Microsoft 365.Experience in IT System Management tool.Familiarity with relevant regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 27001 is highly preferred.Strong understanding of IT infrastructure, software, and data management principles.Strong knowledge of GxP, data integrity requirements, and CSV principles is a plus.Experience with IT infrastructure, backup solutions, and cybersecurity in a regulated environment.Possess a valid certification in Microsoft Windows Server or equivalent.Experience in facility related software and system preferred.Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).Able to work independently and task oriented.Strong team player with a strong set of interpersonal skills.Excellent written and verbal communication skills.Apply now by submitting a Cover Letter and CV to jobs@escoaster.com .
Tell employers what skills you have
GxP
Factory
Azure
Hardware
Change Management
Cell Culture
ISO 27001
Windows Server
Computer System Validation
Telecommunications
Team Player
Microsoft Word
Life Sciences
Cell Therapy
Able To Work Independently