Lead / Senior Engineer (Facilities, Utilities & Equipment)
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.
You will be part of Esco Aster’s Engineering team and contribute
to the overall site mission and objectives. You are responsible for operation
and maintenance of all clean and black utilities, water system, HVAC and
various facilities equipment including fire protection system. This position
will involve the startup phase, liaising with the engineering firm on the
design and construction of the facility, ensuring that the installations comply
to safety guidelines, design intent and quality standards are met.
Reporting
to:
Head of Engineering
·
Serve as the primary engineering point of
contact for Facilities, Utilities, and Equipment.
·
Responsible for plant utilities operations,
facilities (HVAC, electrical, water systems, infrastructure services etc.) and
equipment (BSC, Autoclave, incubators, freezers etc.) maintenance within
regulatory and good engineering practices.
·
Lead Utilities, facilities and equipment
commissioning and decommissioning activities through change management process.
·
Establish and review engineering and
maintenance standard operating procedures and policies.
·
Ensure utilities and facilities operate in a
safe environment by complying with statutory, EHS, and cGMP requirements.
·
Plan and allocate resources to ensure 24/7
continuous system operation, minimizing downtime and ensuring uninterrupted
plant activities.
·
Execute and implement an effective maintenance
and operation program, including work prioritization and compliance with
operational, regulatory, and safety standards.
·
Drive continuous improvement initiatives to
enhance energy efficiency (water & power), sustainability, and asset
reliability while optimizing operational costs.
·
Evaluate and drive technical changes through
the Change Management Process and implement performance enhancements to
minimize downtime and service frequency.
·
Lead troubleshooting efforts and failure
analysis for facilities and utilities systems, supporting maintenance
technicians in addressing issues and improving equipment reliability.
·
Lead/participate in discrepancy management,
root cause identification, and CAPA implementation to prevent recurrence.
·
Lead and develop the Utilities and Facilities
Maintenance team, providing training to enhance technical capabilities. Ensure
the team complies with GMP and site maintenance requirements.
·
Support facility expansion, engineering
projects, and site upgrades, ensuring smooth transition from project to
operation.
·
Participate in facility layout planning,
equipment selection, and procurement processes.
·
Plan and coordinate maintenance activities
across departments, ensuring timely execution with the necessary resources,
parts, and vendors.
·
Oversee and drive routine calibration &
preventive maintenance (PM) and yearly shutdowns, managing outsourced
contractors and maintenance service contracts in line with regulatory, quality,
EHS, and budgetary requirements.
·
Ensure audit readiness by maintaining
compliance with regulatory, statutory, and cGMP requirements. Review and
approve utilities log sheets, work orders, and maintenance records to meet
quality standards.
·
Draft User Requirements Specification
documents for facilities and utilities.
·
Participate in Risk Assessment related
commissioning, qualification, validation and maintenance of manufacturing
equipment, utilities, facilities and processes, ensuring compliance with cGMP
and other regulatory standards.
·
Provide guidance and mentoring to junior staff
and interns, ensuring knowledge transfer and development within the team.
·
Collaborate with internal stakeholders
(manufacturing, process development, quality etc.) and stakeholders to achieve company
objectives.
·
The job responsibilities listed are not
exhaustive and shall also include any responsibilities as assigned by the
Supervisor and Management from time to time to support GMP Facility and company
initiatives.
·
Bachelor’s degree or Diploma in Chemical
Process, Mechanical, Marine, Industrial Engineering or equivalent with a
minimum of 5 years of experience in a highly regulated cGMP manufacturing
environment (Biologics and Pharmaceuticals).
·
Candidates with experience in ATMPs (Cell
& Gene) manufacturing are highly preferred but not mandatory.
·
Self-motivated, proactive and goal-oriented,
capable of working independently.
·
Strong ability to prioritize work and
multitask effectively in a dynamic environment.
·
Experience in cell and gene therapy operations
is an added advantage.
·
Strong knowledge of ISPE Guides, GEP, GAMP,
ASTM compliance, including USFDA, EU, PIC/S cGMP, with hands-on audit
experience (e.g., USFDA, EU, HSA).
·
Hands-on experience in HVAC, central plant
utility systems, Building Management Systems (BMS), Environment Monitoring
Systems (EMS), and cleanroom technologies.
·
Proficiency in CMMS systems, including master
data setup, work order execution, preventive maintenance (PM) programs,
scheduling, and spare parts management.
·
Proficient in MS Office Suite (Word,
PowerPoint, Excel) with excellent oral and written communication skills.
·
Practical knowledge of chillers, cooling
towers, compressed air, diesel generators, cold rooms, process gases,
de-ionized water systems, WFI systems, steam, wastewater, and bio-waste
treatment plants.
·
Excellent communication, interpersonal and
organizational skills.
·
Ability to speak and write in English.
·
Experience in using project management
software such as Asana, monday.com will be an added advantage.
·
Experience in start-up, commissioning, and
qualification of utilities and facilities, with a strong understanding of the
necessary documentation and testing requirements.
Apply now by submitting a Cover Letter and CV to [email protected].