Senior Validation/Validation Engineer

Esco Aster; Singapore; On-site; SGD 60,000 - 80,000; Full time

Benefits offered by this job

Learning and Development

Competitive Compensation

Overseas Travel Opportunities

Job summary

A leading contract research organization in Singapore is looking for a qualified professional to join its MSAT team. The role involves risk-based commissioning and validation of pharmaceutical equipment while following GxP standards. Ideal candidates will have a degree in Engineering or Science, along with 3-5 years in the pharmaceutical industry. Proficiency in technical writing and strong teamwork skills are essential. This position offers the opportunity to contribute significantly to the company's mission of transforming solutions in biosciences.

Qualifications

• Minimum of 3-5 years’ experience in pharmaceutical/biopharmaceutical manufacturing.
• Familiar with working in a GxP environment.
• Good knowledge of CQV approaches including Validation Lifecycle.

Responsibilities

• Perform risk-based commissioning, qualification and validation of equipment.
• Develop validation protocols that fulfill regulatory requirements.
• Coordinate with internal teams to achieve CQV objectives.

Skills

Analytical skills

Technical writing

Communication skills

Team collaboration

Education

Degree and/or Diploma in Engineering/Science

Tools

MS Office Suite

Job description

Join us for the world we are making, redefining biosolutions for current and future generations to come, transcending planetary boundaries, sustainability, and One Health.

Growth

Weempower each other to produce better resultsby providingprofessional advancement and personalgrowth.

Weare driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus onthings that matter mostand help each otherdrive success.

Commitment

We see the good. We work hard. We keep things in balance.

Growth

Weempower each other to produce better resultsby providingprofessional advancement and personalgrowth.

Weare driven by the challenge of creating something new and discovering better opportunities.

We value a positive attitude. We make working a more pleasant experience for everyone.

Communication

We value communication, for it creates better intercultural relationships.

Competence

We focus onthings that matter mostand help each otherdrive success.

We want ourworkforceto become a happier,
healthier, more productive place to work.

BENEFITS

Learning and
Development

Competitive
Compensation

Overseas
Travel Opportunities for
many positions

One Team, One Mission

Are you a seasoned professional looking
foryournext challenge? Be one of us!

The Opportunity

Esco Lifesciences Group is Singapore’s most globalizedlife sciences company, with annual revenues close to SGD 200M and globaloperations in over 42 locations and 26 direct countries across North America,Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of EscoLifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development andmanufacturing organization founded and deeply rooted by scientists enablingfellow scientists to translate their bench work into commercially availableproducts at affordable prices.

Ourscientific work is in emerging and frontier biology utilizing cells as a finalproduct or deriving products from cells which often we use cells as the factoryto derive our target product.

Ourfirst commercial breakthrough success is Esco Aster is commercially first inclass being first in the world to be certified for cultivated/cell-based meatto FSSC 22000 and by a competent food regulatory body.

Weare first in the region to operate an end-to-end integrated full cell linecreation/immortalization or engineered cell line, cell culture processdevelopment, analytical development for stem cells and exosomes with full cGMPCapabilities from Drug Substance and small-scale fill & finish for finalCell Therapy Product.

The work we do creates a remarkable and lasting impacton our world. We offer you an opportunity to be part of this exciting journeyto own your career and firsthand exposure to new emerging modalities supportingtranslational sciences.

Join us as we redefine BioSolutions for One World andOne Health for the current and future generations to come.

One World Biosolutions for One Health.

Who we’re looking for

• 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

Report To:

Selected candidate will report to CEO and others as assigned.

The Scope

You will be part ofEsco Aster's MSAT team and contribute to the overall site mission andobjectives. You will ensure Commissioning Qualification and Validation (CQV)activities and tasks are planned and executed in an efficient and compliantmanner, while adhering to GxP standards. You will work with the Leadership teamof MSAT to develop a continuous improvement mindset and engage in teamwork withcross-functional departments.

Primary worklocation: 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.
• 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.

Requirements

• 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.