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Draftsman and Doc Control

3 weeks ago

Queenstown, Singapore Esco Aster Pte Ltd Full time

**The Opportunity**

Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.

Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.

**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 cGMP 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, Singapore

**Responsibilities**:

- Create technical drawings based on given specifications and calculations from project engineer and engineering personnel.
- Incorporate specifications into drawings and plans that will be used in the CAPEX project and tender submission.
- Liaising with architects and engineers to gather design information, calculating dimensions, weight limitations and structural requirements.
- Develop procedure for drawing or document version control, maintain inventory list, secure access with authorization and updating workflow.
- Create detailed designs with computer-aided design (CAD) software and 3D modeling tools.
- Develop design diagrams, panel schematic diagram, P&ID, maps and layouts to illustrate workflow.
- Assign and upkeep tag number for equipment / instruments for the sites.
- Prepare and review rough sketches and review them along with the engineering team.
- Identify potential operational issues and redesign layout to improve functionality.
- Ensure final designs comply with regulations and quality standards.
- Conduct field inspections and walkdown on project sites to confirm the drawing accuracy.
- Review, maintain and update technical documents (e.g. manuals and workflows).
- File documents in physical location/cabinet with lock and digital records in server for accessing by employees.
- Manage the workflow of documentation relevant to Engineering or CAPEX project.
- Maintain confidentiality around sensitive information and terms of agreement.
- Prepare ad-hoc reports for projects when necessary.
- 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 cGMP environment and keeping up to date with current cGMP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Good knowledge of cGMP, 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.