Readiness Engineer I

Readiness Engineer I is an entry to midlevel position in the Manufacturing department. This position will report directly to the US/DS Readiness Lead but may also have a functional reporting relationship with a senior colleague on a projecttoproject basis.

This role works independently and with colleagues to provide expertise and assistance for the design development standardization and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person would be the liaison between the technical transfer team and Manufacturing and will provide input into the Processes being transferred to Manufacturing to ensure that the Process Designed is executable in Manufacturing. Additionally this engineer may be assigned to revise records between runs or batch campaigns prepare study plans and prepare and execute engineering test plans as needed.

We are Advancing tomorrows medicines and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies we partner with our clients to deliver recombinant proteins viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO) our focus is to combine technical leadership in cell culture microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrows medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies and programs with the ultimate goal of delivering products that transform the lives of patients.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Work under general supervision with latitude for independent judgment.
• Interface with Process Development and Process Sciences to transfer processes into the manufacturing plant.
• Ensure Equipment and room assignment reflects process needs.
• Interact with clients and effectively communicate throughout the multiple stages of a project
• Able to juggle multiple projects and adhere to their corresponding deadlines
• Provide onthefloor support for new and complex projects
• Able to efficiently communicate with internal Clients and Partners (Manufacturing Customer Project Management Quality) and external clients.
• Able to efficiently communicate escalations and potential issues that may lead to a missed deliverable
• Assists in the identification and procurement of process consumable items as it relates to manufacturing readiness and process equipment
• Assist in Process training process and conduct Process Refreshers
• Attend all internal handson training for the SOPs in the curriculum assigned to the position

BACKGROUND REQUIREMENTS:

• A BS/BA in science engineering or another related field is preferred.
• 25 years of experience with a degree or 49 years of experience without a degree in the biotech industry is required. Plant experience is preferred.
• Good working knowledge of cGMP requirements
• Experience with laboratory and/or manufacturing instruments/equipment required
• Experience with Biotech/pharmaceutical processes required
• Due to the various interactions with external and internal groups interpersonal and organizational skills are essential attributes. Must have the ability to work in a crossfunctional team environment

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.

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.

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 .