FUJIFILM

Senior Engineering Manager

Job Locations US-NC-Research Triangle Park
Posted Date 2 weeks ago(6/1/2021 10:48 AM)
Requisition ID
2021-14981
Category
Engineering
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Overview

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Engineering Manager reporting to the Director of Engineering. The successful candidate will lead the Computer Systems Validation (CSV) and Lab Engineering (LE) groups as part of the Engineering Department. The position will ensure deliverables for the respective groups are well established and in line with their stakeholders expectations. The CSV group consists of 2 exempt FDBU employees and 1-2 contractors responsible for validation of computer systems and applications. The LE group consists of 5 exempt FDBU employees responsible for supporting installation of new analytical equipment as well as troubleshooting and preventative maintenance.

The Senior Engineering Manager oversees the day-to-day activities as well as implementation of new technology and continuous improvement aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement.

The Senior Engineering Manager will ensure adequate support of capital projects with a CSV and/or analytical equipment   element in accordance with FDBU and GMP standards to include Data Integrity. As such, this position requires solid working knowledge of computer systems validation and analytical equipment networking.

External US

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Engineering Manager reporting to the Director of Engineering. The successful candidate will lead the Computer Systems Validation (CSV) and Lab Engineering (LE) groups as part of the Engineering Department.

The position will ensure deliverables for the respective groups are well established and in line with their stakeholders expectations. The CSV group consists of 2 exempt FDBU employees and 1-2 contractors responsible for validation of computer systems and applications. The LE group consists of 5 exempt FDBU employees responsible for supporting installation of new analytical equipment as well as troubleshooting and preventative maintenance.

 

Essential Duties and Responsibilities

 

Management

  • Responsible for team of CSV and lab engineers in support of site and departmental goals.
  • Develop and manage team member’s performance and capabilities while providing formal and informal feedback to direct reports
  • Assures team activities are carried out in a manner of compliance with FDBU standards and cGMP regulatory requirements
  • Coaches team members in a learning culture with the goal of achieving employee empowerment and ownership
  • Establishes team objectives and ensures alignment with site and departmental goals
  • Interface and build collaborative partnerships with key site functions including Manufacturing, Process Development Operations, Engineering, and Quality to deliver site goals and objectives
  • Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training
  • Performance
  • Assess equipment and systems to design and implement sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while ensuring data integrity  
  • Ensure support required for capital projects with a CSV and/or analytical equipment element from conception, design and initial specifications through completion and turnover.
  • Support development of User Requirement Specifications, Functional Specifications, and Design Specifications for new computer systems and analytical equipment
  • Support the generation and execution of IOQs and PQs for computer systems and analytical equipment
  • Develop, revise and abide by standard operating procedures
  • Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with computer systems and analytical equipment in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence
  • Provide CSV and analytical equipment subject matter expertise for regulatory inspections and interact with auditors as required
  • Other duties as assigned Management

 

Requirements

  • Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills.       Strong team building skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
  • 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
  • Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel

 

Technical

  • Thorough working knowledge of CGMPs, regulatory guidelines to include data integrity, and validation principles
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise (e.g. process automation, process engineering, quality, etc.)

 

Education and Experience

  • Bachelor's Degree in Engineering related discipline
  • 10+ years relevant experience in cGMP regulated industry
  • 5+ years’ experience managing technical/engineering staff and contract labor

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.

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.

 

In order to ensure the Company’s compliance with the U.S. export laws and regulations, we ask that you answer the following question.

I am one of the following: (a) a citizen of the United States; (b) a lawful permanent resident of the United States; or (c) a person admitted into the United States as an asylee or refugee: YES or NO

  1. If you answered "NO" to Question 1, then please indicate your Citizenship and U.S. Immigration Status: _____.

 

 

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