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Senior Project Engineer

FUJIFILM Diosynth Biotechnologies

This is a Contract position in Irvine, CA posted December 31, 2022.

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 facility Preferred 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 Trackwise Salary 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 or call 979-431-3500.