The Biotechnology Process Sciences Technician I functions within a team based organization to actively address cGMP manufacturing requirements. The individual's main responsibility is to obtain documentation for cGMP appropriate materials (raw materials and components), prepare item specifications for these materials and track the completion of the specification paperwork. The individual will also assist with other cGMP pre-production activities such as the selection of cGMP appropriate materials and equipment as directed. This individual must work in a collaborative manner to assist the transfer of biological drug processes from process development (internal or client) groups in a CDMO environment.
- Contacts vendors to obtain quality documents for new raw materials and/or components that require item specifications.
- Complete item specification paperwork and obtain required approvals for these specifications.
- On a daily basis update the item specification tracking log.
- Assists in the preparation of item specification metrics presentations.
- Contacts vendors or other appropriate sources for information about existing materials.
- Assists in the preparation of user requirements, vendor quotes, and purchasing of equipment.
- Perform all other duties as assigned.
Required Skills & Abilities
Individual will have knowledge/expertise relevant to
- Proficient in utilizing software such as Microsoft Excel, Word, and PowerPoint.
- Excellent attention to detail.
- Ability to build credibility by performing high quality work.
- Demonstrated leadership skills and self-motivation.
- Ability to work in a team oriented environment is essential, as this person will work closely with other team members.
- Good interpersonal communication skills and ability to respectfully communicate comments and concerns in a team environment.
- Ability to go into labs and/or cleanrooms and dress in appropriate attire.
- Familiarity with the manufacturing environment for biologics and vaccine manufacturing is a plus.
- Familiarity with manufacturing equipment and materials is a plus.
- Awareness of Good Documentation Practices is a plus.
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.
- Wear required PPE on occasion.
- Attendance is mandatory.
- Preferred Associate's Degree preferably in Engineering, Chemistry, Biology, Life Sciences or related field; OR
- High School Diploma and 2 years of relevant 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 email FDBTHR@fujifilm.com or call 979-431-3528.