Process Engineer

No deviation Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Generous Leave

Health & Wellness

Professional Development

Inclusive Culture

Impactful Work

Job summary

No Deviation Pte Ltd in Singapore is seeking a Process Engineer to own manufacturing equipment and systems at a biologics site. You will improve performance, reliability and cost-effectiveness, support deviation investigations, change controls and equipment qualification, and assist with regulatory inspections.

Join a team focused on Next Generation Manufacturing technologies, continuous improvement, and collaboration across Manufacturing, Quality, and Validation.

Qualifications

• Bachelor's degree in Engineering (Chemical, Biochemical, Mechanical or related discipline)
• 4 to 7 years of relevant experience in biologics, biotech and pharmaceutical manufacturing
• Working knowledge of cGMP in a regulated environment
• Experience leading deviation investigations and root cause analysis, and developing CAPA
• Experience initiating and managing change controls of moderate to complex scope
• Familiarity with equipment commissioning, qualification and validation
• Ability to troubleshoot equipment, automation and process issues in the field
• Knowledge of contamination control, cleanroom practices and environmental monitoring programmes
• Experience supporting regulatory inspections as SME

Responsibilities

• Recommend, design and implement equipment or system modifications
• Partner with cross-functional teams to implement operational improvements
• Troubleshoot equipment, automation and process issues of simple to moderate complexity
• Help introduce Next Generation Manufacturing technologies into the plant
• Lead deviation investigations and CAPA; manage change controls
• Prepare inspection materials and support regulatory inspections as SME
• Review batch records and identify digitalisation opportunities to improve processes

Skills

Process engineering

cGMP knowledge

Root cause analysis

CAPA

Change control

Equipment qualification

Validation

Data analysis

Technical writing

Cross-functional teamwork

On-call support

Regulatory inspections

Education

Bachelor's in Engineering

Job description

About No Deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Process Engineer serves as process owner for manufacturing equipment and systems at a biologics manufacturing site, applying engineering principles to improve performance, reliability and cost-effectiveness. The role combines process support, contamination control and inspection readiness, working closely with Manufacturing, Engineering, Utilities, Maintenance, Quality Assurance and Validation. The Process Engineer leads deviation investigations, manages change controls and equipment qualification activities, and supports the introduction of advanced "Next Generation Manufacturing" technologies. The role also supports regulatory inspections as a subject matter expert and provides on-call support.

Key Responsibilities

• Recommend, design and implement new equipment or system modifications using engineering principles
• Partner with cross-functional teams to implement operational improvements and ensure reliable, cost-effective process systems
• Troubleshoot and resolve equipment, automation and process issues of simple to moderate complexity, and provide technical support to commercial manufacturing
• Help introduce advanced "Next Generation Manufacturing" technologies into the plant
• Lead root cause analysis for major deviations, and develop and implement corrective and preventive actions (CAPA)
• Initiate and manage change controls of moderate to complex scope, including continuous improvement and productivity initiatives
• Manage changes associated with process equipment commissioning, qualification and validation
• Prepare, analyse and present results and complex information at cross-functional meetings, teleconferences and management reviews
• Support the site contamination control program by owning deviations, leading low-to-moderate complexity investigations and supporting complex ones
• Maintain contamination control dashboards, metrics and trackers, and support cleanroom procedures, gowning practices and environmental monitoring deliverables
• Coordinate with the environmental monitoring sampling team and area owners to ensure sampling readiness and timely closure of observations
• Prepare inspection materials such as storyboards, evidence binders and pressure test packages, and support the triage room during regulatory inspections
• Act as SME to present deviations, CAPA and change control records during inspections, and follow up promptly on inspection requests and observationsReview batch records and documentation, and identify digitalisation opportunities to improve deviation, CAPA and change control processes

Required Qualifications

• Bachelor's degree in Engineering (Chemical, Biochemical, Mechanical or a related discipline) or a related science field
• 4 to 7 years of relevant experience in a biologics, biotechnology and pharmaceutical manufacturing environment
• Working knowledge of cGMP and experience in a regulated environment
• Experience leading deviation investigations and root cause analysis, and developing and implementing CAPA
• Experience initiating and managing change controls of moderate to complex scope
• Familiarity with equipment commissioning, qualification and validation
• Ability to troubleshoot equipment, automation and process issues in the field
• Knowledge of contamination control, cleanroom practices and environmental monitoring programmes
• Experience supporting regulatory inspections, including presenting records as a subject matter expert
• Strong data analysis, technical writing and presentation skills, with the ability to communicate with cross-functional teams and management
• Ability to work independently, prioritise multiple tasks and provide on-call support

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.