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.
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
We are looking for a Senior Process / Facility Engineer to lead the design, integration, and qualification of biopharmaceutical manufacturing facilities, with a focus on upstream processes and aseptic fill-finish systems. The position requires strong expertise in GMP manufacturing, aseptic processing, and facility integration, with hands-on experience in specialized technologies such as isolators, RABS, lyophilizers, robotics, and automation.
Key Responsibilities
- Lead and support process design and facility integration for upstream and aseptic fill-finish systems.
- Act as the client representative for process-related activities, ensuring supplier alignment to specifications.
- Review and follow up on engineering documentation (P&IDs, layouts, datasheets, functional specifications, vessel/piping design, 3D models).
- Manage construction follow-up, SAT execution, and qualification of critical process systems.
- Provide technical troubleshooting and guidance during commissioning and handover.
- Coordinate with cross-functional teams (process design, C&Q, automation, EHS) to resolve technical challenges.
- Oversee integration of specialized technologies (isolators, RABS, lyophilizers, robotics, automation).
- Conduct compliance and risk assessments (e.g., EU Annex 1, cGMP) to ensure regulatory adherence.
- Support project delivery against cost, schedule, and quality objectives.
Required Qualifications
- Degree in Chemical, Process, Mechanical, or Bioprocess Engineering (or related).
- Minimum 10 years of process engineering experience in capital projects for biologics or vaccines.
- Proven expertise in commissioning and qualifying production trains (fermentation, extraction, media/buffer prep, antigen systems).
- Strong knowledge of GMP, aseptic processing, and regulatory guidelines.
- Experience managing complex projects from design through start-up.
- Hands-on exposure to facility integration, isolators, RABS, and high-containment systems.
- Familiarity with project management tools (MS Project, Visio, SchedulePro/SuperPro a plus).
- Strong communication, contractor management, and problem-solving skills.
- Willingness to work onsite in Tuas, Singapore, with flexibility for extended hours during commissioning.
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.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
