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Principal Engineer, Operational Excellence
2 months ago
The Site Engineering division plays a crucial role in the design and commissioning of new machinery as well as managing modifications to existing systems in accordance with FUJIFILM standards and specifications.
This team also spearheads various operational excellence initiatives within the engineering sector and oversees compliance efforts related to validation, including regulatory SIP requalification utilizing contractor resources.
Reporting directly to the Site Engineering Manager, this role is integral to supporting daily plant and maintenance operations, along with projects that range from straightforward equipment procurement (valued between $10K - $1M) to more intricate undertakings involving facility construction or modifications (ranging from $1M - $10M). These projects aim to enhance capacity, reduce costs, improve efficiency, ensure system sustainability, and elevate quality and safety standards.
Key Responsibilities:
- Collect and analyze data, generate reports, and propose corrective actions or enhancements to minimize equipment failures.
- Develop and refine maintenance programs to uphold plant assets, including reviewing and modifying the Preventative Maintenance program to boost equipment reliability.
- Proactively identify engineering challenges or opportunities, applying technical expertise to devise and present viable solutions.
- Respond to and investigate engineering issues for prompt resolution, leveraging vendor or manufacturer expertise as necessary to address equipment and facility-related concerns.
- Support maintenance and inspection tasks on plant equipment in accordance with established procedures, sound engineering practices, and cGMP standards.
- Lead continuous improvement initiatives, troubleshoot complex issues, conduct deviation investigations, perform root cause analysis, and implement CAPAs and change control measures.
- Manage the site-approved lubricant database and the electrical panel schedule database.
- Oversee the annual vessel inspection and passivation/electropolish program.
- Coordinate and review contractor and vendor activities, interfacing with personnel as required to ensure adherence to company standards.
- Assist in identifying new equipment, including considerations for type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, and waste management.
- Maintain open communication channels to manage expectations with stakeholders and end users.
Qualifications:
Skills:
- Ability to organize and present technical information to engineering staff, cross-functional teams, and management independently.
- Knowledge of Reliability Maintenance and Right First Time (RFT) methodologies.
- Strong interpersonal skills and the ability to work effectively in a collaborative environment with employees at all levels.
- Build and maintain effective relationships across functional units, earning their trust and respect.
- Prioritize team goals over individual achievements.
- Share expertise with colleagues to enhance overall knowledge and skills.
- Seek input and feedback from others beyond departmental boundaries as a developmental opportunity.
- Approach situations with objectivity and openness to diverse perspectives.
- Exhibit professionalism and set a positive example for peers.
- Self-motivated and detail-oriented.
- Manage commitments for oneself and the team while demonstrating a willingness to learn and improve continuously.
- Possess excellent presentation skills, capable of articulating sound reasoning and data when recommending actions.
Education and Experience:
B.S. or M.S. degree in Engineering (preferably Chemical, Mechanical, or Electrical Engineering) with over 5 years of relevant experience in the pharmaceutical, chemical, or petrochemical sectors. Experience must include at least 1 year in a GMP-regulated environment.
FUJIFILM Corporation engages with technical data, technology, and materials subject to U.S. export laws and regulations. This position requires access to controlled technical data and technology, necessitating that applicants be U.S. citizens, lawful permanent residents, or otherwise eligible for export authorization from the U.S. Department of State or U.S. Department of Commerce.
FUJIFILM Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
