Senior Engineer I, Validation
Company: Disability Solutions
Location: Bothell
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:
.Position Summary
- The Sr. Engineer I, Validation is a skilled engineer who is
responsible for validation support to the production of
personalized cell therapy products for both global clinical trials
and commercial supply at the Bristol Myers Squibb, Bothell, WA. The
Sr. Engineer I, Validation will be responsible for the preparation,
review, and approval of quality and validation related
documentation and ensuring compliance during validation activities.
This includes developing and delivering GMP equipment, facilities,
and utilities validation programs to ensure compliance with
applicable cGMPs and global health authority regulations.The Sr.
Engineer I, Validation will partner with cross-functional teams to
develop validation plans and ensure their execution and lifecycle
management.Duties/Responsibilities The Sr. Engineer I, Validation
will play a critical role in ensuring compliance with all
regulatory requirements and industry standards related to GMP asset
management and validation in a regulated GMP manufacturing
facility. This position requires a hands-on leader with deep
expertise in GMP, a thorough understanding of lab/manufacturing
equipment, and a proven track record in validation processes.
- Develops and executes validation plan for cGMP critical
equipment and system with validation document deliverable in
respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part
11, computer system validation requirements, EU GMP Annex 15
principles and data integrity requirements.
- Establish validation protocols, risk assessments, and
qualification plans to support GMP operations.
- Acts as a validation Subject Matter Expert (SME) providing
support to multi-function teams, advises operations on validation
matters, and potentially serves as the point of contact to present
validation programs and strategies and defend their work before
Health Authority inspectors and auditors.
- Executes and/or leads multiple projects that require
qualification work arising from change controls, capital projects,
and ongoing supplemental validation deliverable per approved
validation plans as a point of contact for project
stakeholders.
- Work collaboratively with peers within the cross-functional
teams (Facilities and Engineering, IT, Manufacturing, Quality
Control, Supply Chain, Quality Assurance, and Quality Engineering
Validation) to manage workload to address priorities, meet
schedules, maximize productivity, reduce costs and COGM, and
increase efficiencies.
- With minimal supervision, executes validation projects and
tasks assigned and occasionally leads one or more projects within
the validation area and contributes to more complex projects and
initiatives for the broader site.
- Leads teams with specialized focus on strategic validation
projects to evolve the organization. With some frequency, makes an
impact on the broader validation team.
- Regularly reviews, prioritizes, and promptly responds to
customer equipment qualification and support requests.
- Quickly learns from others and consistently steps up
proactively. With some frequency, proactively supports other team
members and helps them to be successful.
- Routinely seeks opportunities to learn BMS values. Excels in
demonstrating one of the BMS values (Integrity, Innovation,
Passion, Urgency, Inclusion, Accountability) and works to address
perceived deficiencies.
- Support Global MSAT including our R&D site to execute
validation related projects and make standardization across the
sites. Develop and manage an ongoing monitoring program for GMP
assets to ensure continued compliance and performance.
- Foster a culture of compliance, quality, and continuous
improvement within the validation team.
- Stay abreast of all relevant GMP regulations, FDA guidelines,
and international standards to ensure lab operations remain in full
compliance.
- Interface with regulatory agencies during inspections and
audits, serving as the subject matter expert for validation
processes.
- Act as the primary point of contact for validation-related
inquiries during regulatory inspections and audits.
- Provide expert guidance and support to ensure that all
validation processes and documentation meet regulatory
expectations.
- Collaborate with cross-functional teams to address any findings
related to validation and implement corrective actions as
necessary.
- Oversee the qualification and validation of laboratory
instruments, equipment, and systems, including but not limited to
analytical instruments, autoclaves, and environmental monitoring
systems.
- Implement risk-based validation approaches to optimize
processes and reduce validation cycle times while maintaining the
highest quality.
- Ensure all validation documentation, including protocols, test
scripts, and reports, are accurately completed, reviewed, and
archived in accordance with company policies.
- Identify opportunities for process optimization and efficiency
improvements within the validation function, collaborating with
cross-functional teams as needed.
- Develop and deliver training programs for validation team
members to enhance their capabilities and knowledge of validation
principles and practices. Qualifications
- Bachelor's Degree in life sciences/engineering/STEM or
equivalent
- 5+ years of commissioning, qualification, and validation (CQV)
experience within technical and regulated industries
- Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations,
including 21CFR part 11, computer systems validation requirements,
EU GMP Annex 15, and data integrity requirements
- Experience with equipment/utility/facility qualifications and
general commissioning, qualification and validation CQV practices
are required.
- Experience with investigations, deviations and CAPA management
in a regulated pharmaceutical industry are required.
- Experience and in-depth understanding of validation lifecycle
deliverables and documents from equipment design through
qualification (starting with URS, to the end of IQ/OQ/PQ and SR)
and computer system validation (CSV) documents through system
retirement.
- Excellent project and program management, communication skills,
and technical writing skills are required.
- Knowledge and experience with electronic document management
systems for quality record, procedural documents and validation
lifecycle documents are desired.
- Possess the professionalism and technical competency required
to represent the department before our customers, regulatory
agencies, and management.
- Experience in the Pharma/Biopharma required, cell therapy
industry is plus.
- Detail oriented, with strong GMP, Validation and Engineering
experience
- Experience utilizing regulatory knowledge to drive innovation
and improvement in validation and engineering functions.The
starting compensation for this job is a range from $92,000 to
$121,000, 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 .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.BMSCARTIf 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 , Senior Engineer I, Validation, Engineering , Bothell, Washington
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