Engineer - Process Engineering

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

The Engineer is responsible for ensuring the reliability, performance, and compliance of assigned biotechnology process equipment. This role supports daily manufacturing operations by acting as the subject matter expert for equipment, leading troubleshooting and investigations, and driving continuous improvement initiatives. The engineer works closely with cross-functional teams to maintain equipment in a validated state, support new product introductions (NPI), and contribute to engineering projects, ensuring minimal disruption to operations and sustained production efficiency.

Key Responsibilities

• Own and manage assigned process equipment to ensure safe, compliant, and reliable operations
• Act as subject matter expert for equipment performance, troubleshooting, and optimization
• Lead equipment breakdown investigations and perform root cause analysis
• Develop and implement corrective and preventive actions (CAPA)
• Manage deviations and change controls related to equipment performance
• Collaborate with cross-functional stakeholders to resolve operational issues
• Support equipment readiness for NPI and product changeovers
• Perform equipment assessments during qualifications and change activities
• Develop and optimize maintenance strategies (e.g., preventive maintenance, job plans in Maximo)
• Ensure completion of periodic reviews, data integrity, and security assessments
• Analyze and present data for operational issues and engineering projects
• Support site projects as SME or System Owner, including design reviews and technical transfers
• Participate in equipment installation, system walkdowns, and project handovers
• Drive continuous improvement initiatives using operational excellence and data analysis tools
• Benchmark equipment performance and implement reliability improvements

Required Qualifications

• Degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field
• Experience in biopharmaceutical or biotechnology manufacturing environment
• Strong knowledge of process equipment, single-use systems, and GMP requirements
• Experience with deviation management, CAPA, and change control processes
• Hands-on troubleshooting and root cause analysis experience
• Familiarity with maintenance systems (e.g., Maximo) is an advantage
• Experience supporting NPI, CQV, or engineering projects preferred
• Strong communication and stakeholder management skills
• Ability to work independently and manage multiple priorities

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.

Skills

Subject Matter Expert, Deviations, Technical Product Support, Root Cause Analysis, Biotechnology, Preventive Actions, Equipment Qualification, Process Safety Management, Stakeholder Management, Project Engineering, Biopharmaceuticals, Mechanical Engineering, Change Control Management