Process Engineer

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.

We are seeking a motivated and technically strong Process Engineer to support a new technology & scale‑up project within a pilot‑scale manufacturing facility. This role will focus on capital project execution, commissioning & qualification, and process engineering support to enable the safe and efficient introduction of new processes into the facility. You will collaborate closely with operations, engineering, quality, and external vendors to ensure that new equipment and processes are designed, installed, qualified, and implemented in accordance with project requirements, internal standards, and regulatory expectations.

• Lead capital projects from initiation to completion, defining scope, developing execution strategies, and delivering within approved timelines and budgets.
• Lead cleanroom qualification activities, including environmental qualification, airflow visualization, and classification tests, ensuring compliance with regulatory and internal standards.
• Identify gaps or limitations in new process capabilities and recommend engineering solutions to enhance plant readiness.
• Develop and justify project scopes, capital requests, and investment proposals.
• Lead and oversee commissioning activities, prepare commissioning reports, and ensure smooth handover to operations.
• Develop, review, and execute IQ/OQ/PQ protocols and related validation documentation in line with GMP and QMS requirements.
• Address and resolve validation deviations promptly, escalating concerns where necessary.
• Prepare process engineering documentation to support technology transfer into commercial manufacturing environments.
• Collaborate with cross‑functional teams to ensure processes are designed for safe, scalable, and efficient manufacturing.

• Bachelor's degree in Chemical Engineering or a related discipline.
• 3–5 years of experience in API or pharmaceutical process engineering, manufacturing, or pilot‑plant operations.
• Strong knowledge of cleanroom and equipment commissioning, qualification, and validation principles.
• Experience in cleanroom qualification (ISO 14644, EU GMP Annex
  1) including airflow visualization, HEPA integrity testing, and environmental monitoring setup.
• Familiarity with GMP, EHS requirements, and engineering standards.
• Hands‑on experience in capital project execution and equipment troubleshooting.

• Generous leave policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive health & wellness coverage: robust medical and dental coverage to support your health needs.
• Professional development opportunities: 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.

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.

Not applicable.

Contract.

Management and manufacturing.

Pharmaceutical Manufacturing.