Process Sciences Engineer II

at  Fujifilm

THE WORK WE DO AT FDB HAS NEVER BEEN MORE IMPORTANT—AND WE ARE LOOKING FOR TALENTED CANDIDATES TO JOIN US. WE ARE GROWING OUR LOCATIONS, OUR CAPABILITIES, AND OUR TEAMS, AND LOOKING FOR PASSIONATE, MISSION-DRIVEN PEOPLE LIKE YOU WHO WANT TO MAKE A REAL DIFFERENCE IN PEOPLE’S 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 FDB 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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas’ population lives within a 180-mile 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.
Summary: 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.
External US:

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 single-use 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 hands-on experience.
• Trains other members of the team with respect to the day-to-day 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 day-to-day 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.
• Self-motivated and capable of demonstrating technical competence.
• Excellent interpersonal communication skills and ability to influence and collaborate in a team environment.
• Analytical and excellent problem-solving 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 hand-eye 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
• Master’s Degree with 4 years of relevant experience; OR
• Bachelor’s Degree with 6 years of relevant experience; OR
• Associate’s 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.

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 cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams.
• Identification of single-use process equipment of appropriate scale and quality for the cGMP execution 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 execution 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.

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 hand-eye 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