FUJIFILM

Senior Process Engineer

Job Locations US-NC-Research Triangle Park
Posted Date 1 month ago(4/9/2021 8:52 AM)
Requisition ID
2021-14727
Category
Engineering
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Overview

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a Process Engineer within the Engineering department.  The successful candidate will support capital and operational projects with equipment design, commissioning, FAT/SAT testing and installation.  Working with the other functions within engineering, the position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations. FDBU Engineering consists of project, process, automation, and lab analytical responsible for both capital and operational projects in support of manufacturing, process development, and facilities/maintenance.

External US

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a Process Engineer within the Engineering department.  The successful candidate will support capital and operational projects with equipment design, commissioning, FAT/SAT testing and installation.  Working with the other functions within engineering, the position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations. FDBU Engineering consists of project, process, automation, and lab analytical responsible for both capital and operational projects in support of manufacturing, process development, and facilities/maintenance.

 

Reporting directly to the Director of Engineering, this position 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.

 

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
  • Working with end user, create URS for new equipment
  • Review equipment P&ID and other design documents to ensure engineering standards and operational needs are satisfied
  • Maintain open channel of communication to manage expectations with stakeholders and end users
  • Manage testing activities for projects, including mechanical and automation commissioning, installation and operational qualification
  • Ensure project documents are created accurately in a timely manner and review vendor / contractor documents including datasheets, drawings, specification documents, test documents, or other equipment documents
  • Respond to and research engineering problems for timely resolution to include leveraging vendor or manufacturer expertise to solve equipment and facility related problems

Requirements

Management

  • Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills
  • Must be flexible and able to manage multiple priorities and projects
  • Must be results driven and goal oriented with the ability to manage risks
  • Hands-on active management style while maintaining awareness of team activities
  • Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to upper management
  • Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management
  • Maintains effective relationships across functional units gaining their trust and respect
  • Puts accomplishing the goals of the group ahead of accomplishing individual goals
  • Openly shares knowledge/information needed to accomplish a task or solve a problem
  • Exhibits professionalism and sets an example for others to follow
  • Self-starter and detail oriented with high energy and positive approach
  • Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve

Technical  

  • Practical knowledge and application of cGMP requirements and systems
  • Practical knowledge of pharmaceutical manufacturing operations and equipment utilized in upstream, downstream, media prep, CIP/SIP, etc.
  • Practical knowledge of clean and dirty utilities
  • Practical knowledge of equipment design (stainless steel and single use) and safety standards
  • Understanding of equipment and process validation
  • Experience managing outside contracting firms
  • Proficiency with MS Project, MS PowerPoint, MS Excel, MS Word, Visio, and SharePoint and other most common applications for analysis/problem resolution
  • Keen ability to assess end user processes and operational needs
  • Problem-solving mentality to creatively troubleshoot unexpected process or equipment issues

 

Education and Experience

  • B.S. Degree in Engineering Discipline (Mechanical or Chemical preferred) with 5+ years relevant experience in process equipment engineering.  Experience must include 2+ years in GMP regulated industry
  • M. S. Degree in Engineering Discipline (Mechanical or Chemical preferred) with 3+ years relevant experience in process equipment engineering.  Experience must include 2+ years in GMP regulated industry

 

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.

 

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.

 

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.

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