Senior Project Engineer
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: June 16, 2022
Job Description:
Overview Summary: - The Sr. Project Engineer, under the
supervision of the Director of Engineering, will be responsible for
leading, preparing, coordinating and monitoring the implementation
of the assigned engineering projects including the development of
any specifications and infrastructure requirements, discussion with
A&E firms, project documentation review, contractors and/or
vendor coordination, field progress inspection and project closeout
documentation on behalf of the different facilities at Fujifilm
Diosynth Biotechnology Texas (FDBT). Assigned projects may be
related to new product introductions, local capital projects and/or
strategic projects as dictated by the business needs. This position
will work closely with facilities, manufacturing resources, CAPEX
team, validation, QA/QC, contractors and other functional areas to
execute and document the projects Change Controls procedures as the
main system for documenting changes to the facility, utility and/or
equipment as applicable. This position will also support P&IDs
development, maintenance strategies development, SOP's development
and equipment commissioning/qualification activities as required.
External US Essential Functions:
- Lead, prepare, coordinate, monitor and manage the
implementation of assigned engineering projects.
- Develop equipment/system specifications, identify
infrastructure requirements and perform capability assessments as
required for each project.
- Review, markup and ensure project documents such as
specifications, submittals, RFIs, test documents, drawings and/or
other project specific documents are created and documented
accurately.
- Responsible for the generation of the change controls
associated with the assigned projects conforming with industry
standards, quality and regulatory expectations.
- Work with outside contracting firms to bring projects from the
conceptual design stage to implementation and providing solutions
to technical problems that may arise during the life of the
project.
- Coordinate project activities with A&E designers, General
Contractors and vendors.
- Inspect field progress of building construction,
equipment/systems modifications and/or improvements
- Establish the methods by which all field tests are administered
and monitor the quality of those tests.
- Actively review projects status and communicate progress and
constrains.
- Track and ensure completion of project punch list items.
- Liaison with CAPEX team for the implementation of capital
projects.
- Support new product introductions (NPIs).
- Oversee contractors during projects implementation as
required.
- Works with QA/QC to ensure proper testing, inspection and
release after completion of project implementation.
- Support equipment IQ/OQ/PQ or any other
validation/commissioning startup activity as required.
- Ensure new equipment operates in compliance with required EHS,
regulations and codes.
- Develop, write, edit and/or review in collaboration with
Facilities SOPs, P&IDs and maintenance procedures for new
equipment and/or systems.
- Communicate efficiently with Contractors, Suppliers, OEM
providers as well as internal equipment owners and operators for a
successful operation of the FDBT facility.
- Able to work with other contractors, manufacturing, validations
and quality control personnel regarding changes or improvements to
the systems.
- Ensure compliance, as set forth in internal quality protocols
and SOPs including cGMP and FDA regulatory guidelines, within the
areas of responsibility, and document out of specification
conditions with deviations, CAPAs and Change Controls as
appropriate.
- Continuously stay current with assigned SOPs and keep up to
date training file ensuring compliance with all applicable Standard
Operating Procedures.
- Ensure a safe work environment is maintained through adherence
and compliance with safety guidelines, policies, site procedures
and job performance qualifications.
- Demonstrate continuous personal pursuit to increasing job
knowledge, proficiency in technical understanding, and
problem-solving abilities.
- Maintain a positive, professional, and customer-oriented
attitude.
- All other duties as assigned.Required Skills & Abilities:
- Identify engineering problems or opportunities and apply
technical expertise to develop and present feasible solutions.
- Demonstrate leadership, technical aptitude, and problem-solving
skills.
- Must be flexible and able to manage multiple projects,
priorities and tasks.
- Must be results driven and goal oriented with the ability to
manage risks.
- Knowledge and understanding using P&IDs, equipment manuals,
specifications, SOPs, and be able to use proper judgment when
implementing projects.
- Strong analytical and problem-solving skills. Possess or have
the ability to apply these skills to resolve technical problems and
to gain knowledge with respect to the operation of utility/process
systems.
- Must be able to develop, and draft operational procedures and
maintenance procedures for technical (utilities/process) equipment
using the OEM manual and system knowledge.
- Possess or have the ability to gain knowledge of FDA, OSHA,
EH&S, EPA, and state of Texas requirements.
- Must be able to use project management software such as
Microsoft Project. Proficient with MS Office products (Word, Excel,
Outlook, PowerPoint).
- Knowledge of regulatory requirements for manufacturing of
pharmaceutical products.
- Strong written and verbal communications 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.
- Be self-starter, self-motivated, detail oriented and possess
interpersonal skills.
- Ability to learn quickly and work effectively with little
supervision when needed.
- Desire to work in a fast paced, state of the art, alternately
research and customized manufacturing facility.
- Knowledge of bio-medical, bio-technical equipment, both
upstream and downstream highly desirable.
- All other duties as assigned. -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, walking, bending,
stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate portable tools, test instruments, as well as a computer
keyboard, telephone, calculator, and other office equipment is
required.
- Have a normal range of vision.
- The ability to regularly lift and/or move up to 50 pounds.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may require off shifts, weekends and/or holidays
support.
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is Mandatory -Minimum Qualifications:
- Bachelor's Degree preferably in Electrical, Chemical,
Mechanical or Biomedical Engineering
- Ten (10) years of qualified experience in an engineering role
in an FDA regulated research or manufacturing facilityPreferred
Qualifications:
- Relevant project engineering experience in a biotechnology or
pharmaceutical development and manufacturing environment managing a
portfolio of multiple complex projects
- Knowledge of quality management software specifically
TrackwiseSalary: - Starting salary will be commensurate with
education and experience. -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 e-mail
FDBTHR@fujifilm.com or call 979-431-3500.
Keywords: FUJIFILM Holdings America Corporation, College Station , Senior Project Engineer, Engineering , College Station, Texas
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