Process Sciences Engineer II
Process Sciences Engineer II
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1 Vacancy
Job Description
Position Overview
The Engineer II functions within a team based organization to actively address complex cGMP manufacturing issues. The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what FUJIFILM Diosynth Biotechnologies call Genki.
College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.
Job Description
Essential Functions:
- Applies scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
- Lead multiple overlapping crossfunctional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
- Identification of singleuse process equipment of appropriate scale and quality for the cGMP of client specified manufacturing processes.
- Prepares user requirements obtains vendor quotes and Capital Requests for equipment.
- Provides technical information for the preparation of change controls protocols and new user training for the process equipment.
- Reviews process specifications and provides input for scale up and requirements for GMP manufacturing.
- Reviews batch records prepared based on the process specification.
- Identifies raw materials and consumables of appropriate quality for the cGMP of client specified manufacturing processes; assists in the preparation of material specifications vendor quotes and the purchase of the materials.
- Responds to client and/or internal staff questions or concerns about cGMP equipment materials and procedures.
- Uses key and critical process parameters and their associated critical quality attributes in the preparation of product specifications.
- Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables.
- Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.
- Perform all other duties as assigned.
Required Knowledge/Technical Expertise
Individual will have knowledge/expertise relevant to:
- Working within cGMP environments in relation to biologics and vaccine manufacturing.
- Hands on process development or manufacturing experience with clinical scale projects.
- Experience with singleuse manufacturing equipment and materials.
- Documented understanding and experience in aseptic techniques.
- Document writing including protocols batch records and SOPs and summary reports.
- Experience with Microsoft Excel Word and PowerPoint and materials management with SAP.
Other Abilities:
- Build credibility by performing high quality work.
- Expand the technical capabilities of teams using academic and handson experience.
- Trains other members of the team with respect to the daytoday goals and activities by imparting their expertise to the group.
- Effectively communicates results of own work through meetings presentations discussions and documentation with some input from supervisor.
- Minimum supervision required on daytoday activities and accomplished tasks.
- Ability to work in a team oriented environment is essential as this person will work closely with other team members and clients.
- Selfmotivated and capable of demonstrating technical competence.
- Excellent interpersonal communication skills and ability to influence and collaborate in a team environment.
- Analytical and excellent problemsolving skills.
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 standing along with some bending stooping and stretching.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment.
- Ability to lift up to 20 pounds regularly and up to 50 pounds on occasion.
- Potential for exposure to hazardous chemicals gases fumes odors mists and dusts and other hazardous materials.
- Ability to wear personal protective equipment to include safety glasses lab coat gloves or other equipment as required.
- Attendance is mandatory.
Minimum Qualifications:
- PhD; OR
- Masters Degree with 4 years of relevant experience; OR
- Bachelors Degree with 6 years of relevant experience; OR
- Associates Degree with 8 years of relevant experience.
Preferred Qualifications:
- Experience in a cGMP environment.
- Degree preferably in Engineering Chemistry Biology Life Sciences or related field.
Join us! FDB is advancing tomorrows 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.
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 viaemail 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.
EEO Information
Fujifilm is committedto 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 Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.
Employment Type
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