SR Process Engineer

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

CAI is a 100% employee-owned companyestablishedin 1996 that has grown year over year to almost 750 people worldwide. We provide commissioning qualification validation start-up projectmanagementand other consulting services to mission critical industries. We are global partner in providing professional services to enhance operational performance and reliability. We deliver consistentlyExpertlyandCompletely.

The Role

In this role you willbe responsible forensuring operability and reliability of equipment. This role is highly execution-focused and requires regular on-the-floor presence to support manufacturing operations troubleshoot equipment issues in real time and directly support technicians and operators as work closely with Manufacturing Process Development andiParkEnd Users to investigate troubleshoot and repair issues related to process equipment.

Youwillmonitorprocess performance and recommend/implement equipment related process and continuous improvement expect youto enjoyworking in a fast-paced dynamic and innovative environment.

Employee Type: Full Time Employee

Work location:Fujisawa KanagawaJapan

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:4-8yearsrelevant 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.

-a year

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

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience: