Process Sciences- Sr. Engineer
The Senior Engineer functions independently and productively 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 takes responsibility for 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.
- Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines.
- Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Will also be responsible for assisting other teams as SME.
- Research and recommend single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes.
- Responsible for the preparation of user requirements, vendor quotes, and purchasing of equipment as well as supporting capital projects by providing technical expertise.
- Oversees and leads small complex engineering projects.
- Assist in overseeing contractor activities, as required.
- Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment.
- Reviews process requirements for GMP manufacturing through process specifications and batch records.
- 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 to assist 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:
- supporting single-use equipment and systems such as:
- Fermentation and Cell Culture reactors
- GE AKTA chromatography systems supported by Unicorn software
- Tangential Flow Filtration Systems
- Depth Filtration systems
- Working within cGMP environments in relation to biologics and vaccine manufacturing.
- Process development or manufacturing experience with clinical scale projects.
- Single-use manufacturing equipment and materials.
- Understanding and experience in aseptic techniques.
- Document writing including protocols, batch records, and SOPs and summary reports.
- Using Microsoft Excel, Word, and PowerPoint.
- Demonstrated credibility by performing high quality work.
- Coaching and mentoring less experienced team members.
- Expand the technical capabilities of teams using academic and hands-on experience.
- 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.
- PhD with 1 year of relevant experience; OR
- Master's Degree with 6 years of relevant experience; OR
- Bachelor's Degree with 8 years of relevant experience; OR
- Associate's Degree with 10 years of relevant experience.
- Experience in a GMP environment.
- Degree in Engineering, Chemistry, Biology, Life Sciences or related field.
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 FDBTHR@fujifilm.com or call 979-431-3528.