Validation - Planning & Logistics Engineer

  Our Validation team in College Station, Texas is expanding, and we are looking for a Planner and Logistics Engineer to provide technical and operational support-coordination for the execution of projects, improvements, installation, operations, maintenance and compliance of FUJIFILM Diosynth Biotechnologies Texas, LLC Validation department to meet organizational goals and objectives. This position will also work closely with other operators, engineers and managers coordinating and planning multiple activities and projects. While implementing continue operations improvements principals to the department.

External US

Essential Functions

• Support validation personnel in daily activities, daily meetings, and non-routines tasks.
• Perform coordination and scheduling of daily validation support, validation related projects and general tasks based on priorities.
• Search, develop and implement improvements and technics to the operations of the department.
• Work with other departments and validation resources to define priorities and provide preliminary assessment for validation requests.
• Support quality and compliance aspects like change controls routing and generation, corrective action / preventive action, deviations, impact assessments and qualifications as applicable to the validation department.
• Work effectively to gather information for the set-up, creation, and maintenance of tracking tools such as Smartsheets, MS Project and other similar software's.
• Work with purchasing systems like SAP, purchase requisitions, tracking order status and deliveries.
• Work with CMMS systems to schedule and complete work requests.
• Performs other duties as assigned.

Required Skills & Abilities

• Excellent verbal and written communication skills required for discussing complex business processes
• Technical writing experience
• Positive, customer service-oriented skills and behavior
• Ability to coordinate, facilitate, and organize resources
• Possesses the skills and capability to plan ahead and stay on schedule
• Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
• Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
• Strong written, verbal, and interpersonal communications skills and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment.
• Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, changing work environment.
• Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point) and general computer knowledge.
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to

• Experience prolonged sitting, standing, bending, stooping, climbing, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Be exposed to noisy environments.
• Travel time up to 10%.
• Wear required PPE.
• Support company manufacturing activities 24/7.
• Attendance is mandatory.

Minimum Qualifications

• Bachelor's degree in Engineering or Life Science discipline.
• Associates degree in an Engineering or Life Science discipline or related field with two (2) years of qualified experience in an FDA or other regulated engineering role.
• High School Diploma/GED with follow on education in a technical school or trade with four (4) years of qualified experience in an FDA or other regulated engineering role.

 Preferred Qualifications

• Experience with critical and non-critical utilities, biotechnology equipment and complex pharmaceutical systems are a plus.

Join us!  FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

 

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.

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.