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.

At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity, and transparency to every activity, including engagement with our candidates. We are an equal opportunity employer, value diversity, and promote inclusivity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

We are hiring for a Process Design Engineer for ATMP (Advanced Therapy Medicinal Products) who will be responsible for designing and optimizing manufacturing processes for advanced therapy medicinal products, which include gene therapies, cell therapies, and tissue-engineered products.

What you will be doing :

Generate and/or review process design documents (i.e. P&IDs, PFDs, URS, data sheets, as-built documents, manuals etc.) in Conceptual Design, Basic Design and Detailed Design phases
Participate safety & design reviews (i.e. 3D model, HAZOP and DQ)
Manage project and / or site change control
Prepare bidding documents for process equipment, perform technical evaluation of supplier’s quotation and manage the supplier in terms of technical, quality, schedule and changes
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

What you will need:

Minimum Degree in Engineering or Science Disciplines
Minimum 3 years’ experience in a related field / Pharmaceutical Industry
Experience in facility design, manufacturing process, process equipment and regulatory requirements for ATMP products
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
Be IT literate and familiar with Microsoft office suite of applications
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