Process Engineer

1 day ago

Singapore No Deviation Pte Ltd Full time

About Nd

Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe.

We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy and regulatory quality and compliance. With a sharp focus on delivering value-adding commissioning, qualification, and validation services, we are leading experts in developing the lean CQV methodology. We extend our offerings to GMP-certified software for environmental monitoring and contamination control, paperless validation, training, and professional recruitment services.

We place keen attention on patient safety, process understanding, regulatory compliance and efficiency in the areas of safety, quality, delivery, and cost.

What you will be doing:

- Generate and/or review process design documents (P&IDs, PFDs, URS, data sheets etc.)
- Participate safety & design reviews (i.e. 3D model, HAZOP and DQ)
- Manage project and / or site change control
- Vendor management
- Participate Quality Risk Assessment
- Review and approve other technical documents, wherever applicable
- Reporting of status of the assigned project/task
- Execute and/or coordinate all field work, wherever applicable
- Execute and/or coordinate commissioning, qualification and validation activities
- Overall responsibility for HSE matters in appointed area
- Troubleshooting and resolution of process related issues
- Management of deficiencies and deviations
- Provide SME input wherever required
- Support SOP generation
- Coordinate with identified stakeholder
- Complete trainings in a timely manner

Job Requirements:

- Minimum Degree in Engineering or Science Disciplines
- Minimum 3 years’ experience in a related field / Pharmaceutical Industry
- Proven track record in following and promoting Safety in all aspects of your role
- Strong process and automation knowledge, adequate knowledge in utility and HVAC
- Project management / coordination experience
- Proactive and self-motivated
- Adequate knowledge on cGMP and other regulatory requirements, guidelines and industry best practices
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

EA License No**:19C9587

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