Location: REMOTE Midwest to East Coast Region US
Field Systems Engineer (FSE)
The Single Use Technologies business with the BioProduction Division, part of Thermo Fisher Scientific, provides best-in-class single use systems to our customers. The Hardware Engineer is responsible for managing all aspects of field service support and customer relationship management. The successful candidate will provide complete services on Single Use Bioreactor, Single Use Fermenter, and Single Use Mixing systems, including equipment demonstrations, installations, qualification (FAT, SAT,IQ/OQ), troubleshooting and any necessary service/repairs, and preventative maintenance. Our ideal candidate will be customer oriented, an advocate for Thermo Fisher Scientific in customer laboratories, and be eager to drive growth.
In addition, this position will provide the necessary technical support to ensure optimal Single-Use technologies, products and services are utilized within the customers’ manufacturing processes and will provide support of process optimization and scale-up as needed.
Key Duties and Responsibilities:
- Oversee and perform on-site installation, qualification, service and repairs of Single-Use Systems including Bioreactors, Fermenters, and Mixing Systems
- Perform FAT (Factory Acceptance Testing) on equipment when needed.
- Must be client-focused, working in conjunction with other internal teams and Commercial Sales
- Provides a communication link between the customer and the company to help ensure that effective service is provided to the customer
- Reviews Customer User Requirements Specifications (URS) and product specifications; Collaborates with customer and internal teams on product opportunities
- Analyzes review and inspection findings to determine source of problem, and recommends repair, replacement, or other corrective action
- Provide necessary VOC and insight to new technologies that could complement the existing range from the perspective of identified customer needs
- Develops and conducts effective training activities on safe operations of equipment and demonstrates skills to trainees, including both team members and customers
- Supporting Commercial Sales activities in providing customer technical support and product troubleshooting
- Support Field Applications team as needed in providing effective value-added solutions on design and development, optimization, consultation, technical support, and troubleshooting of Single-Use systems to our customers
- Other duties that may be assigned
- Comprehensive knowledge of Single-Use systems including Bioreactors, Fermenters, and Mixers and Bioprocess Containers (BPCs)
- Comprehensive understanding of processes and applications used within the biopharmaceutical, biotech, human and animal vaccine industries
- Comprehensive knowledge and understanding with proven operational and technical experience in hardware installations and qualification and system integration
- Good knowledge & understanding of cGMP & other regulatory guidelines for the Biotech and Biopharmaceutical manufacturing industry
- Excellent knowledge and experience with integrated controls systems (i.e. Delta V, Siemens, and Allen Bradley) typically used within the Biotech and Biopharmaceutical Industry
- Good project management skills combined with the ability to multi-task effectively
- Highly motivated and self-directed requiring minimal supervision including the ability to work on multiple projects
- Excellent communication and team-working skills
- Ability and willingness to work across professional & cross-functional teams
- Excellent computer skills including experience of Microsoft Office (Word, Excel, PowerPoint, & Project), AutoCAD, Solid Works or other related design software
- Willingness to travel up to 60% of time and operate from a home-base
- Maintain a valid driver’s license and safe driving record
Non-Negotiable Hiring Criteria:
- Bachelor’s Degree (or work related equivalent) in an Engineering, Technical, Life Science, or related field
- 5-7 years of experience working within the biotech, biopharmaceutical, biologics, and/or life sciences industries in an engineering, technical or manufacturing capacity
- Proven hands-on experience in hardware installations, qualifications (IQ/OQ), integrated control systems integration and ideally with experience using Single-Use products
This position has not been approved for Relocation Assistance.