CAI

Operational readiness consulting for pharma

Senior Process Engineer

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeFujisawa, Kanagawa, Japan¥5.8M - ¥9.2M /yrIn-person

About the Job

Requirements

A B.S. or M.S. in Chemical or Mechanical Engineering, or equivalent.
Four to eight years of relevant experience in Engineering or Operations.
Proficiency in Japanese and working proficiency in English are preferred.
Be self-directed and have effective analytical and problem-solving skills; deliver results on multiple complex assignments simultaneously with minimal required direction from a supervisor.
Interact effectively with other groups and take ownership of and follow through on assignments.
Use a technical background and structured problem-solving approach to investigate issues, determine root causes, and develop effective corrective and preventative actions.
Excellent verbal and written interpersonal and communication skills are required.
Present work to peers and cross-functional managers and influence leadership decisions; technical writing skills are required.
Manage time and deliver to program timelines.
Experience evaluating production line performance, including Overall Equipment Effectiveness (OEE), reliability performance metrics such as Mean Time Between Failures (MTBF) and Mean Time To Failure (MTTF), and life cycle management.
Familiarity with Microsoft Office Suite is required.

Responsibilities

Provide direct engineering support and subject matter expertise for equipment including ultrafiltration, chromatography, single-use mixers, temperature control units, fermenters, reaction vessels, microfluidizers, analytical equipment, component preparation equipment, and critical utilities.
Develop, deliver, and support training for manufacturing operators and technicians on equipment operation, troubleshooting, and best practices to ensure consistent and reliable execution of Enzymatics processes.
Directly support manufacturing activities, including hands-on troubleshooting, equipment setup, and recovery activities when required.
Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.
Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, qualification, and fit-for-purpose validation of facilities or equipment, as applicable.
Respond to alarms, out-of-specification conditions, and out-of-tolerance conditions, and ensure product impact assessments are performed as necessary.
Troubleshoot equipment to determine root causes of failure modes, independently drive failure resolution and repair, and own corrective/preventative actions and associated change controls.
Support implementation of the Enzymatics computerized maintenance management system (CMMS) program for asset and maintenance management of relevant equipment.
Own and support maintenance and repair of Enzymatics equipment assets through the computerized maintenance management system, including preventative maintenance plans, calibration data sheets, spare parts, and work-order workflows, as applicable.
Coordinate and support end-to-end vendor-driven repair, calibration, and maintenance of equipment where necessary.
Own and support quality records, including change controls, deviations, and corrective and preventative actions, related to Enzymatics equipment in a non-GMP but controlled manufacturing environment.
Maintain engineering turnover packages, including specifications, component lists, operating manuals, and drawings for Enzymatics equipment.
Document activities related to manufacturing setup, troubleshooting, and automated method updates in accordance with applicable standard operating procedures and guidelines.
Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
Provide guidance and training on new processes and equipment.
Work closely with the Quality Assurance team to ensure manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, corrective and preventative actions, and out-of-tolerance investigations.
Ensure manufacturing activities comply with health, safety, and environmental regulations.
Perform operational assessments to ensure procedures and tools are in place.
Follow relevant International Organization for Standardization (ISO) regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks as defined in internal guiding documents, including standard operating procedures and work instructions.
Follow Good Documentation Practices and data integrity requirements so data, documentation, and records are completed and maintained for business use and available to support audits or inspections.
Complete training in the assigned required learning plan according to defined timing and prescribed requalification cadence.

Desired Qualifications

Experience in a Good Manufacturing Practice (GMP) or regulated manufacturing environment.
Familiarity with common industry unit operations such as chromatography, tangential flow filtration, and fermentation/cell culture.
Basic statistical analysis techniques.

Salary Range: 5814000 to 9177000 (Currency: JPY) (Pay period: per-year-salary)

CAI Overview
Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:
• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Employee Type: Full Time Employee

Work location: Fujisawa, Kanagawa, Japan

Responsibilities

Provide direct engineering support and subject matter expertise for equipment including Ultrafiltration, Chromatography, Single Use Mixers, Temperature Control Units, Fermenters, Reaction Vessels, Microfluidizers, Analytical Equipment, Component Prep Equipment, Critical Utilities, and more.

Develop, deliver, and support training for manufacturing operators and technicians on equipment operation, troubleshooting, and best practices, ensuring consistent and reliable execution of Enzymatics processes. Leverage subject matter expertise to directly support execution of Manufacturing activities, including hands-on troubleshooting, equipment setup, and recovery activities when required.

Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.

Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, qualification, and fit-for-purpose validation of facilities and/or equipment, as applicable.

Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.

Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution and repair, own Corrective/Preventative Actions and associated Change Controls.

Support implementation of Enzymatics CMMS program to enable asset and maintenance management for all relevant equipment.

Own and support maintenance and repair of Enzymatics equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows as applicable).

Coordinate and support end-to-end vendor-driven repair, calibration and maintenance of equipment, where necessary.

Own and support quality records (e.g., Change Controls, Deviations, CAPAs) related to Enzymatics equipment, appropriate for a non-GMP but controlled manufacturing environment.

Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for Enzymatics equipment.

Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.

Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.

Provide guidance and training on new processes and equipment.

Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.

Ensure all manufacturing activities comply with health, safety, and environmental regulations.

Perform operational assessments to ensure procedures and tools are in place.

Follow all relevant ISO regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Requirements

Education:B.S. or M.S. in Chemical or Mechanical Engineering or equivalent

Experience:4-8 years relevant experience in Engineering or Operations

Other Quantifiable Preference

Experience in a GMP or regulated manufacturing environment preferred.

Familiar with common industry unit operations such as Chromatography, Tangential Flow Filtration, Fermentation/Cell Culture preferred.

Proficiency in Japanese and working proficiency in English preferred

Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously with minimal required direction from their supervisor.

Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

Must be able to use their technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.

Excellent interpersonal and communication skills (verbal and written) are required.

Expected to be able to present their own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills are required.

Demonstrated ability to manage your own time and deliver to program timelines.

Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.

Familiarity with Microsoft Office Suite is required, and basic statistical analysis techniques are preferred.

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

CAI is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind.

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size: 1,001-5,000
Company stage: Pre-seed
Total funding: $3.4M
Headquarters: Indianapolis, IN
Founded: 1996

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