Project Engineer II

Project EngineerThe 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 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.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 provide 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 improvementsEstablish the methods by which all field tests are administered and monitor the quality of those tests.Actively review projects status and communicate progress and constraints.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:Technical Expertise : Providing engineering and troubleshooting support, develop and present feasible solutions.Problem Identification and Solution Development : Spotting engineering issues and crafting solutions.Project Management : Leading installations and projects improvements.Project Execution : Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when implementing projects.Equipment Expertise : Select and specify equipment types and specifications and ensure it operates in compliance with regulations and codes.Collaborative/Coordination Skills : Working cross-functionally with teams like CAPEX and QA/QC. Coordinate execution of projects, improvements, and other engineering activities.Communication : Strong written and verbal communications skills with the ability to effectively communicate within cross-functional teams and upper management.Validation and Compliance : Assisting in equipment validation activities and adhering to environmental, health, and safety guidelines.Documentation and Procedures : Crafting URS, SOPs, P&IDs, and maintenance protocols. using the OEM manual and system knowledge.Effective Communication : Coordinating with diverse stakeholders effectively, including presenting technical overviews, such as FDA, OSHA, EH&S, EPA, and state of Texas requirements.Regulatory and Industry Knowledge : Understanding regulatory requirements and pharmaceutical manufacturing guidelines, including bio-medical, bio-technical equipment, both upstream and downstream is highly desirable.Continuous Improvement and Learning : Keeping up-to-update with SOPs and enhancing technical and problem-solving skills.Leadership and Professionalism : Demonstrating leadership, maintaining a positive approach, and managing multiple priorities efficiently.Results Orientation : Being goal-focused with strong analytical and risk management abilities.Software Proficiency : Proficient in project management software and MS Office.Adaptability and Self-motivation : Thriving in a fast-paced environment, learning swiftly, and working independently.Safety : A focus on safety and compliance with regulations at the forefront of all activities.All other duties as assigned.Working Conditions & Physical Requirements: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 MandatoryMinimum Qualifications:Bachelor's Degree preferably in Electrical, Chemical, Mechanical or Biomedical EngineeringTwo (2) 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 projectsKnowledge of quality management software specifically TrackwiseEEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io or View phone number on click.appcast.io).