FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a Staff Project Engineer. The successful candidate is recognized as a senior level project manager/engineer with an extensive background in capital project management. The position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations. The Project Engineering group consists of 3 – 4 project engineers responsible for both capital and expense project management in support of manufacturing, process development, and facilities/maintenance.

Reporting directly to the Associate Director of Engineering, the Staff Project Engineer oversees the day-to-day project management activities of capital projects ranging from simple scope equipment procurement ($10K – $1M) to more complex scope involving facility construction/modification ($1M – $10M) aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement.

Essential Duties and Responsibilities

  • Lead / manage the execution of capital projects pursuant to project requirements.
  • 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 conceptual design stage to execution ensuring completion within time and budgetary constraints while delivering a high quality end product
  • Coordinate and review contractor and vendor activity and interface with personnel as required ensuring all company standards are maintained
  • Ensure thorough engineering standards for project execution, design, equipment standards, safety, and cost control
  • Direct procurement of required equipment and materials for a specific project, including fabrication, off-the-shelf components, and custom components
  • Maintain open channel of communication to manage expectations regarding project scope, timeline, progress, and required customer feedback
  • 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 project-specific 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
  • Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve

Technical

  • Proficient knowledge of pharmaceutical cGMP requirements and systems
  • Knowledge of regulatory requirements for manufacturing of pharmaceutical products
  • Strong project management capabilities; cost estimation; project scheduling; capital equipment specification, procurement and qualification; hands on equipment problem solving ability; experience in process validation; experience in cGMP manufacturing environment
  • Prior 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
  • Ability to effectively communicate requirements to vendors and manufacturers
  • Insight into customer processes and operational needs
  • Problem-solving mentality to creatively troubleshoot unexpected process or equipment issues
  • Strong interpersonal communication and leadership skills
  • Must be energetic, positive, detail-oriented, and self-motivated
  • Project Management Professional (PMP) certification is a plus
  • AutoCAD proficiency is a plus

Education and Experience

  • B.S. Degree in Engineering Discipline (Mechanical, Chemical, Electrical, Biochemical preferred) with 15+ years relevant experience in project or process engineering. Experience must include 10+ years in the pharmaceutical industry
  • M.S. Degree in Engineering Discipline (Mechanical, Chemical, Electrical, Biochemical preferred) with 12+ years relevant experience in project or process engineering. Experience must include 7+ years in the pharmaceutical 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.

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