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.

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 seeking an experienced Process Lead Engineer to provide technical leadership and process engineering support for pharmaceutical manufacturing operations.The role will have particular ownership of CIP, SIP, washers and autoclaves, while supporting process design, equipment qualification, troubleshooting, continuous improvement and automation-related activities. The successful candidate will act as a key technical interface between Manufacturing Science & Technology (MS&T), Engineering, Automation and Operations to ensure reliable and compliant manufacturing operations.

Key Responsibilities

• Process Engineering & Equipment Ownership
• Qualification & Validation
• Process Improvement & Troubleshooting
• Automation & MS&T Interface
• Quality & Change Management
• Technical Leadership
• Provide technical ownership and engineering support for CIP, SIP, washers, autoclaves and associated process systems.
• Develop and maintain process engineering documentation throughout the equipment and process lifecycle.
• Support process and equipment design activities, including:
• P&ID development and review
• User Requirements Specifications (URS)
• System Risk Assessments (SRA)
• Functional Risk Assessments (FRA)
• Design Reviews / Design Qualification
• HAZOP and other process risk assessments
• Provide technical support for equipment and process modifications, upgrades and improvement initiatives.
• Support FAT, SAT, commissioning, IQ, OQ, PQ, qualification, requalification and validation activities.
• Provide process engineering input during equipment qualification and ensure systems meet operational and process requirements.
• Support investigation and resolution of qualification-related issues and deficiencies.
• Lead engineering-related continuous improvement initiatives to improve:
• Process reliability
• Equipment performance
• Yield
• Cycle time
• Operational efficiency
• Lead complex process and engineering troubleshooting beyond frontline operational troubleshooting.
• Develop and implement solutions to minimise manufacturing and supply risks.
• Drive optimisation of processes such as CIP/SIP cycles and equipment operating parameters.
• Provide independent technical support to ensure smooth day-to-day site operations.
• Act as a key technical bridge between MS&T and Automation.
• Translate process requirements into appropriate automation requirements, including:
• Equipment modules
• Recipes
• Process parameters
• Control sequences
• Support recipe development and testing.
• Work closely with Automation teams to implement and verify process-related automation changes.
• Lead and manage process engineering-related:
• Change Controls
• Deviations
• CAPAs
• Technical investigations
• Ensure engineering changes are appropriately assessed for their impact on process performance, product quality and GMP compliance.
• Support risk assessments and implementation of corrective and preventive actions.
• Provide technical leadership and support to manufacturing, engineering and cross-functional teams.
• Represent the process engineering function during meetings and technical discussions when required.
• Support or deputise for the Engineering Lead where necessary.
• May provide limited oversight or coordination of engineering resources.
• Support technical decision-making and provide practical solutions to manufacturing issues.

Required Qualifications

• Degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology or another relevant engineering discipline.
• Strong process engineering experience within a pharmaceutical, biologics or GMP manufacturing environment.
• Hands-on experience with CIP and SIP systems is highly preferred.
• Good working knowledge of equipment such as:
• Parts / equipment washers
• Autoclaves
• Process vessels
• Clean utilities
• Automated process equipment
• Experience supporting IQ/OQ/PQ, FAT, SAT, commissioning and validation activities.
• Experience with change control, deviation investigations and CAPA management.
• Strong understanding of P&IDs, URS, process risk assessments and HAZOP.
• Experience working with Automation and MS&T teams and translating process requirements into automation recipes and parameters.
• Strong process troubleshooting and root cause analysis capability.
• Able to independently identify technical problems and develop practical engineering solutions.
• Strong stakeholder management and communication skills.

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.