Overview

Reporting directly to the Manager of Process Engineering, the Process Engineer II will support projects ranging from simple scope equipment procurement ($10K - $1M) to more complex scope involving facility construction/modification ($1M - $10M) aimed at capacity increase, cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement. Additionally, this position will include up to 30% compliance validation / equipment requalification related activities, as directed by the site master validation plan.

External US

The Process Engineering team is responsible for the design and commissioning of both new equipment and the management of changes to existing equipment in line with FDBU standards and specifications. In addition, the team is responsible for most operational excellence (continuous improvement) initiatives within the engineering department and oversight of FDBU validation compliance efforts such as regulatory SIP requalification utilizing contractor resourcing.

Reporting directly to the Manager of Process Engineering, the Process Engineer II will support projects ranging from simple scope equipment procurement ($10K - $1M) to more complex scope involving facility construction/modification ($1M - $10M) aimed at capacity increase, cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement. Additionally, this position will include up to 30% compliance validation / equipment requalification related activities, as directed by the site master validation plan.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions
• Work with outside contracting firms to bring projects from the design stage to execution ensuring end user requirements are met
• Coordinate and review contractor and vendor activity and interface with personnel as required ensuring all company standards are maintained
• Lead the identification of new equipment including but not limited to proper type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, and waste requirements
• Working with end user, create user requirement specifications (URS) for new equipment
• Maintain open channel of communication to manage expectations with stakeholders and end users
• Manage testing activities for projects, including factory acceptance testing, site acceptance testing, mechanical and automation commissioning, and installation / operational qualification
• Ensure project documents are created accurately in a timely manner and review vendor / contractor documents including datasheets, drawings, P&IDs, specification documents, test documents, or other equipment documents
• Respond to and research engineering problems for timely resolution, including leveraging vendor or manufacturer expertise to solve equipment and facility related problems
• Lead and manage process improvements, corrective and preventive actions (CAPAs) and change control implementations for process equipment
• Provide technical support in case of equipment related deviations in root cause investigation and implementation of CAPAs
• CIP and SIP circuit development and qualification
• Process Engineering Team Breakdown
  • 50% - New Equipment Design and Commissioning
  • 30% - Validation Compliance
  • 20% - General support and continuous improvement

MINIMUM REQUIREMENTS:

Skills:

• Ability to organize and present technical overviews to engineering staff, cross functional departments, and management without assistance
• Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
• Maintains effective relationships across functional units gaining their trust and respect
• Puts accomplishing the goals of the team ahead of accomplishing individual goals
• Openly shares expertise with co-workers to help strengthen general knowledge and skills
• Solicits input / feedback from others beyond role or departmental boundaries as developmental opportunity
• Approaches situations objectively and is receptive to various viewpoints
• Exhibits professionalism and sets an example for others to follow
• Self-starter and detail oriented
• Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve
• Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action

Education/Experience:

• S. or M.S. Degree in Chemical, Mechanical, or Biomedical Engineering with 3-5 years relevant experience in process equipment engineering. Experience must include 1 years in GMP regulated industry. Experience developing and executing validation / qualification protocols is preferred

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU 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 identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.