Job Description

Process Engineer - Singapore - 6 months contract with extension

Location: Singapore

Start Date: ASAP

Contract: 6 months contract likely to be extended

The Company

A service provider leading the Pharmaceutical and Medical Device sectors since 1998. A Company that is constantly growing and has over 2000 employees worldwide.

Roles and responsibilities

You will expected to provide support in site process engineering, installation verificiation, pre-commissioning, SAT and commissioning of equipment/utilities/ancillaries, used in biotech facilities.

You will also be required to:

• Be responsible for documentation development, SOP drafting, sequence of operation optimization and documentation
• Follow standard operating procedures and standards in a highly regulated environment
• Generate and execute procedures/protocols through GMP verification process
• Adhere to safe work practices
• Clearly communicate progress and issues to management and peers and finalize report writing for test protocols
• Perform all tasks in strict compliance with operating procedures, best practices, and regulatory requirements
• Provide feedback to leadership regarding potential issues and concerns with documentation
• Accountable for accurately completing GMP documentation

• Chemical Engineering master degree
• At least 3 years related process engineering design experience, with preferred experience in biotech, with understanding of automated process equipment, systems architecture and operations, and related components
• Knowledge of cGMPs and main pharmaceutical standards and rules
• Knowledge of process control and P&IDs standard settings and ISA standard symbology
• Knowledge of safety current rules for equipment/ plants design and attention to health and safety practices within the working environment
• Previous experience in equipment and process and equipment validation is helpful, but not just focusing on this
• Technical expertise in GMP biotech processes that include upstream & downstream manufacturing and clean utilities
• Ability to manage priorities, deliverables, and scheduled milestones
• Requires strong interpersonal, verbal communication, and technical writing skills

Leap29