Principal Engineer, OEM Technology Development & Integration Lead
Company: Disability Solutions
Location: Seattle
Posted on: October 2, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more: .Title:
Principal Engineer, OEM Technology Development & Integration
LeadLocation: Seattle, WACell Therapy is one of the most
groundbreaking new forms of cancer treatments being studied today.
With therapies only in their infancy and BMS's continued investment
in our Cell Therapy capabilities, the growth potential of this
science, your career, and the ability to help patients are
incredible.We are seeking a Principal Engineer to lead the design,
development and integration of bespoke cell therapy production
technologies in efforts to advance next generation cell therapy
manufacturing. The OEM Technology Development & Integration Lead
will leverage their expertise in cell therapy operations and GMP
system design to actively shape, define and lead the ideation and
development of industrial cell therapy production technologies and
ensure process and analytical integration within BMS' manufacturing
platform. Specifically, the OEM Technology Development &
Integration Lead will systematically evaluate the current state of
BMS' cell therapy production, in conjunction with our process
constraints, and create and execute a design and development
strategy to attain highly robust and reliable production systems,
in collaboration with internal and external partners.Key
Responsibilities:
- Leverage a deep understanding of BMS' current state cell
therapy technologies, operations and process constraints to
establish and execute a development and automation technical
strategy for the creation of highly robust and reliable production
systems, in collaboration with key OEMs.
- Provide technical and project leadership to internal and
external stakeholders and partners to drive the development of
novel and customized equipment, single-use systems and automation
software for executing process operations unique to cell therapy
manufacturing.
- Oversee the transformation of novel prototype and early
development equipment into GMP ready unit operation platforms in
preparation for deployment into clinical and commercial
manufacturing operations.
- Evaluate OEM system configurations and designs, and draft
standard GMP equipment project documents including User Requirement
Specifications, Design Specifications, Process and Equipment System
FMEA to inform OEM system designs and tech transfer packages.
- Lead the evaluation & testing of bespoke prototype and GMP
systems to demonstrate suitability for applicable cell therapy
processes and integration with BMS' manufacturing platform, in
alignment with OEM system and functional requirements.
- Develop a comprehensive equipment & system reliability
program/champaign for equipment systems to achieve high-capacity
and autonomous cell therapy production. This includes the creation
of a comprehensive Process and Equipment FMEA, OEM technology
design integrations against known system failure modes, creation of
auto-recovery methods and systematic characterization of OEM system
robustness.
- Creation of internal service and maintenance strategy and
executable plan associated with OEM technologies to minimize system
downtime and recovery.
- Lead supplier interfaces and manage external relationships in
efforts to drive innovation and successfully execute on project
deliverables.Qualifications & Experience:
- Ph.D in an engineering field with 4+ years of experience in
design and development of process or analytical equipment/ systems
for biologic, cell and/or gene therapy products. B.S./M.S. in a
scientific or engineering field with 8+ years of process or
analytical equipment development experience. Experience in cell and
gene therapy technology development preferred.
- Experience in developing and implementing automated
technologies and/or automation systems into GMP manufacturing.
DeltaV automation expertise is preferred.
- Strong experimental design skills with hands-on experience with
development and operationalization of cell therapy technologies to
support end-to-end process applications.
- Experience drafting standard GMP equipment project documents
including User Requirement Specifications, Design Specifications,
FAT Protocols, Installation/Operation Qualification Protocols, Tech
Transfer Package.
- Experience executing equipment of facility qualification
protocols (FAT, SAT, IQ, OQ, etc.).
- Familiarity with GMP biomanufacturing requirements, preferably
direct experience working in a GMP environment.
- Broad knowledge of equipment and pharmaceutical facility
industrial standards and guidelines including ICH Q7, GAMP5, NEMA,
UL
- Experience drafting, reviewing, and approving equipment systems
drawings and designs.
- Can-do attitude and ability to work in a highly matrixed and
dynamic business environment.
- Deep scientific curiosity and commitment to advancing
therapeutic innovation that provides better options for
patients.
- Strong problem-solving and risk-based decision-making skills
and a strong ability to influence or manage without direct
authority.
- Highly developed interpersonal, communication and negotiation
skills.
- Self-motivated individual with demonstrated ability to lead and
support highly cross-functional teams.
- Demonstrated ability to analyze technical data and design
experiments. If you come across a role that intrigues you but
doesn't perfectly line up with your resume, we encourage you to
apply anyway. You could be one step away from work that will
transform your life and career. The starting compensation for this
job is a range from $127,000 - $159,000, plus incentive cash and
stock opportunities (based on eligibility). The starting pay rate
takes into account characteristics of the job, such as required
skills and where the job is performed.Final, individual
compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may
vary based on the job and location. For more on benefits, please
visit our BMS Career Site. Benefit offerings are subject to the
terms and conditions of the applicable plans then in effect and may
include the following: Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and
employee assistance programs (EAP). Financial well-being resources
and a 401(K). Financial protection benefits such as short- and
long-term disability, life insurance, supplemental health
insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional
holidays, Global Shutdown days between Christmas and New Year's
holiday, up to 120 hours of paid vacation, up to two (2) paid days
to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave. Family care
services such as adoption and surrogacy reimbursement,
fertility/infertility benefits, support for traveling mothers, and
child, elder and pet care resources. Other perks like tuition
reimbursement and a recognition program. #LI-HybridBMSCARTVETERANIf
you come across a role that intrigues you but doesn't perfectly
line up with your resume, we encourage you to apply anyway. You
could be one step away from work that will transform your life and
career. Uniquely Interesting Work, Life-changing CareersWith a
single vision as inspiring as Transforming patients' lives through
science--- , every BMS employee plays an integral role in work that
goes far beyond ordinary. Each of us is empowered to apply our
individual talents and unique perspectives in an inclusive culture,
promoting diversity in clinical trials, while our shared values of
passion, innovation, urgency, accountability, inclusion and
integrity bring out the highest potential of each of our
colleagues.On-site Protocol BMS has a diverse occupancy structure
that determines where an employee is required to conduct their
work. This structure includes site-essential, site-by-design,
field-based and remote-by-design jobs. The occupancy type that you
are assigned is determined by the nature and responsibilities of
your role: Site-essential roles require 100% of shifts onsite at
your assigned facility. Site-by-design roles may be eligible for a
hybrid work model with at least 50% onsite at your assigned
facility. For these roles, onsite presence is considered an
essential job function and is critical to collaboration,
innovation, productivity, and a positive Company culture. For
field-based and remote-by-design roles the ability to physically
travel to visit customers, patients or business partners and to
attend meetings on behalf of BMS as directed is an essential job
function. BMS is dedicated to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace accommodations/adjustments and ongoing support
in their roles. Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, South Hill , Principal Engineer, OEM Technology Development & Integration Lead, IT / Software / Systems , Seattle, Washington
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