Process Engineer

• Global Company
• Collaborative and inclusive work culture
• Continuous Professional Development

We are delighted to partner, with our client a world leader in technical services, providing global expertise across 18 countries. The company provides solutions and services that support the energy, commercial and digital needs of industries, cities and buildings where performance improvement, reliability and innovation are essential. We are seeking an experienced Process Engineer to join the Integrated Facility Management team supporting a pharmaceutical manufacturing facility. This is a highly hands-on and execution-focused role, requiring regular on-the-floor presence to support manufacturing operations, troubleshoot equipment issues in real time, and provide direct technical support to technicians, operators and cross-functional teams.

Responsibilities include:

• Providing direct engineering support and subject matter expertise for manufacturing and process equipment, including ultrafiltration systems, chromatography systems, single-use mixers, temperature control units, fermenters, reaction vessels, microfluidizers, analytical equipment, component preparation equipment and critical utilities.
• Supporting manufacturing operators and technicians through training, equipment troubleshooting, best-practice guidance and hands-on support where required.
• Reducing manufacturing events, user interventions and batch record excursions by ensuring equipment and machinery operate reliably and effectively.
• Participating in all phases of engineering projects relating to process equipment, including design, procurement, asset induction, construction, installation, start-up, commissioning, qualification and validation activities.
• Responding to alarms, out-of-specification conditions and out-of-tolerance events, ensuring appropriate product impact assessments are completed where required.
• Troubleshooting equipment failures, identifying root causes and driving corrective and preventative actions through to completion.
• Supporting the implementation and use of CMMS systems for asset and maintenance management.
• Managing and supporting preventative maintenance plans, calibration data sheets, spare parts and work order workflows.
• Coordinating vendor-led repair, calibration and maintenance activities where required.
• Supporting quality records including change controls, deviations and CAPAs relating to equipment in a non-GMP but controlled manufacturing environment.
• Maintaining engineering turnover packages, including specifications, component lists, operating manuals and equipment drawings.
• Documenting manufacturing setup, troubleshooting activities and automated method updates in accordance with SOPs, work instructions and applicable guidelines.
• Developing and implementing updates for automated processing equipment methods with minimal disruption to operations.
• Providing guidance and training on new processes and equipment.
• Working closely with Quality Assurance to ensure manufacturing processes meet internal and external requirements.
• Ensuring manufacturing activities comply with health, safety and environmental regulations.
• Performing operational assessments to ensure appropriate procedures, tools and systems are in place.
• Following ISO regulations, internal policies, SOPs, work instructions, Good Documentation Practices and Data Integrity requirements.
• Completing assigned training within required timeframes and requalification schedules.

This role is ideal for someone who enjoys working in a fast-paced, dynamic and innovativemanufacturing environment and is confident providing practical engineering support in regulated or controlled environments.

About you

• A bachelor’s or master’s degree in chemical engineering, Mechanical Engineering or an equivalent discipline.
• Significant relevant experience in engineering, manufacturing operations, process equipment or facilities support.
• Experience working in GMP, pharmaceutical, biotechnology, life sciences or another regulated manufacturing environment is preferred.
• Familiarity with industry unit operations such as chromatography, tangential flow filtration, fermentation and/or cell culture.
• Experience with process equipment troubleshooting, root cause analysis, CAPA management and change control.
• Experience evaluating production line performance, including OEE, MTBF, MTTF, reliability metrics and lifecycle management.
• Strong analytical, technical and problem-solving skills.
• The ability to manage multiple complex assignments with minimal supervision.
• Excellent interpersonal and communication skills, both written and verbal.
• Strong technical writing skills and the ability to present work clearly to peers, managers and cross-functional stakeholders.
• The ability to influence decisions and work effectively across departments.
• Good time management skills and the ability to deliver against project and operational timelines.
• Proficiency in Microsoft Office Suite.
• Basic statistical analysis skills would be advantageous.
• Japanese language proficiency and working-level English proficiency are preferred.