Validation Engineer

ESCO ASTER PTE. LTD.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Esco Aster Pte Ltd is seeking a dedicated MSAT CQV professional to lead commissioning, qualification and validation for biopharma equipment, utilities and processes in a GxP setting. You will prepare validation protocols, write reports and coordinate with multiple teams to ensure compliance.

The role requires a degree in engineering or science, strong CQV knowledge, and the ability to travel if required. Singapore site-based position with full-time commitment.

Qualifications

• GxP knowledge and regulatory awareness for pharma/biopharma.
• CQV/Validation lifecycle experience (URS, DQ, FAT/SAT, IOQ, CSV).
• Strong technical writing and presentation skills.
• Excellent written and verbal communication; able to coordinate cross-functionally.

Responsibilities

• Perform risk-based CQV activities for equipment, utilities, facilities and processes.
• Develop validation protocols and regulatory-compliant reports.
• Coordinate with internal teams and external vendors to meet CQV objectives.
• Prepare design reviews, URS and qualification documents as needed.
• Investigate deviations and contribute to CAPA and incident reports.

Skills

GxP knowledge

CQV/Validation

Technical writing

Communication

Education

Engineering/Science degree

Tools

MS Office

Job description

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.

The Scope

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

Job Responsibilities

• 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 FMEA and 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.
• Support Engineering and Facilities functions as needed.
• Undertake tasks assigned by leaders as and when appropriate.

Requirements

• Degree and/or Diploma in Engineering/Science or related studies.
• Minimum 1 year of experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred.
• 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 escalation any relevant issues.
• Strong team player to work with both internal and external stakeholders.
• Develop positive relationship with a strong set of interpersonal skills.
• Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.