Senior Validation/Validation Engineer
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.
Physical/Mental Requirements/Work Environment
- Ability to read, analyze and interpret scientific data and publications
- Ability to author or review protocols, technical reports and technology transfer documents.
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus
- Repetitive motions due to certain laboratory techniques
Selected candidate will report to CEO and others as assigned.
You will be part of
Esco Aster's MSAT team and contribute to the overall site mission and
objectives. You will ensure Commissioning Qualification and Validation (CQV)
activities and tasks are planned and executed in an efficient and compliant
manner, while adhering to GxP standards. You will work with the Leadership team
of MSAT to develop a continuous improvement mindset and engage in teamwork with
cross-functional departments.
Primary work
location: Ayer Rajah Crescent, Singapore
- Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes.
- Develop validation protocols and reports that fulfil regulatory requirements and industry best practices.
- Assist in developing User Requirements Specification documents.
- Prepare design review and design qualification documents at the initial design stage to align with specifications.
- Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ).
- Prepare and execute validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.
- Complete assigned CQV tasks according to planned schedule, budget, safety and engineering standards.
- Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives.
- Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives.
- Investigate deviations and write deviation reports and findings.
- Undertake tasks assigned by leaders as and when appropriate.
- Degree and/or Diploma in Engineering/Science or related studies.
- Minimum of 3-5 years’ experience in pharmaceutical/biopharmaceutical manufacturing facility.
- Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
- Competent in technical writing and presentations.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Strong team player to work with both internal and external stakeholders.
- Develop positive relationship with a strong set of interpersonal skills.
Apply now by submitting a Cover Letter and CV to [email protected].