Senior Validation Engineer I (Aseptic Processing & Environmental Controls)
Company: Disability Solutions
Location: Bothell
Posted on: May 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:
careers.bms.com/working-with-us .Position SummaryThe Senior
Engineer I, Validation is responsible for supporting the production
of personalized cell therapy products for clinical and commercial
supply at the BMS Manufacturing Plant (Jump), in Bothell, WA. The
Senior Engineer I, Validation is responsible for ensuring the
compliance of aseptic processes and environmental control systems.
The Senior Engineer I, Validation supports airflow visualization
study (AVS), aseptic process simulation (APS), cleanroom
reclassification (CRC), environmental monitoring performance
qualification (EMPQ), and non-routine simulation (NRS) programs as
a member of the Jump Manufacturing Sciences and Technology (MSAT)
department. This role involves developing and executing validation
protocols, as well as providing technical expertise and guidance to
ensure the highest level of quality and regulatory compliance to
ensure patient safety and implement best in class
practices.Duties/Responsibilities
- Develops and executes validation plan for cGMP critical
equipment and system with validation document deliverable in
respect to cGMP, GDP, GXP, including 21CFR Part 11, , EU GMP Annex
1 principles.
- 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.
- Develop, execute, and report on APS, AVS, CRC, EMPQ, and NRS
aseptic and environmental control activities and manage
requalification schedule for routine APS and CRC
- Plan APS, AVS, CRC, EMPQ, and NRS aseptic and environmental
control activities and coordinate cross-functional teams comprised
of Materials Management, Manufacturing, Patient Services,
Scheduling, Quality Assurance, Quality Control, and Validation
- Investigate and resolve deviations and non-conformances with
oversight from Validation and Quality Assurance leadership
- Maintain accurate and up-to-date validation documentation,
including protocols, reports, and standard operating procedures
(SOPs), in compliance with regulatory standards
- Develop and manage electronic validation documentation such as
risk assessments, protocols, studies, and reports using the
ValGenesis validation lifecycle information management system
- Serve as a subject matter expert for aseptic and environmental
control programs
- Support quality record processing through assisting in impact
assessments and owning action items
- Provide oversight, training, and support to APS, AVS, CRC,
EMPQ, and NRS participants during aseptic and environmental control
activities
- Support cross-functional efforts to ensure regulatory
compliance and protect patient safety
- Follow validation regulations, policies, standards, procedures,
and work instructions
- Provide strong technical knowledge of cellular therapy systems,
materials, equipment, and aseptic processing techniques
- Provide technical input and investigation support for
production related investigations to maintain the validated state
of the aseptic process
- Stay current with industry standards and participate in best
practice forums consistent with function responsibilities
- Work collaboratively with peers within the cross-functional
teams (F&E, IT, MFG, QC, Supply Chain, and QA/QEV) 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.
- 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 GMSAT to execute validation related projects and make
standardization across the sites.Reporting RelationshipThis
position will report to the Associate Director- Validation,
Engineering & Technology (VET), MSATQualifications
- Bachelor's Degree in life sciences/engineering/STEM or
equivalent
- 4+ years of experience in the biotechnology, biopharmaceutical,
or cell therapy industry
- 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 leading small teams and projects
- Strong Knowledge of cGMPs and multi-national regulations,
related to aseptic processes and environmental control systems
- Knowledge of microbiology, aseptic processing, and facility
qualification
- Knowledge of facility, engineering, and contamination
controls
- Experience with the development, validation, and licensure of
new biopharmaceutical manufacturing facilities
- Experience with validation methodologies, including IQ,OQ, and
PQ, as well as risk assessment tools.
- Experience with single-use sterile technologies and closed
systems
- Experience working with external parties and leading
cross-functional teams
- Ability to interpret data and use sound science to drive
decision-making
- Ability to prioritize and provide clear direction to team
members in a highly dynamic environment
- 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 -
$115,000, plus incentive cash and stock opportunities (based on
eligibility). The starting pay takes into account characteristics
of the job, such as required skills and where the job is performed.
Final, individual compensation is decid ed based on demonstrated
experience. For more on benefits, please visit our BMS Careers si
te. Eligibility for specific benefits listed in our careers site
may vary based on the job and location. 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. WORKING CONDITIONS (US
Only):This job description is intended to describe the general
nature and level of work being performed by the person assigned to
this position. The primary duties and responsibilities are intended
to describe those functions that are essential to the performance
of this job.This job description does not state or imply that the
above are the only duties and responsibilities assigned to this
position. There are other duties and responsibilities that are
considered incidental or secondary to the overall purpose of this
job. Employees holding this position will be required to perform
any other job-related duties as requested by management.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.
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 ProtocolPhysical presence at the BMS worksite or
physical presence in the field is a necessary job function of this
role, which the Company deems critical to collaboration,
innovation, productivity, employee well-being and engagement, and
it enhances the Company culture.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 adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility 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.Any data processed in connection with role applications will
be treated in accordance with applicable data privacy policies and
regulations.
Keywords: Disability Solutions, Seattle Hill-Silver Firs , Senior Validation Engineer I (Aseptic Processing & Environmental Controls), Engineering , Bothell, Washington
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