PRINCIPAL ENGINEER, ENGINEERING TESTING & ANALYSIS (TEAM LEAD)
Company: AbbVie
Location: Irvine
Posted on: October 17, 2024
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Job Description:
Company DescriptionAbbVie's mission is to discover and deliver
innovative medicines and solutions that solve serious health issues
today and address the medical challenges of tomorrow. We strive to
have a remarkable impact on people's lives across several key
therapeutic areas - immunology, oncology, neuroscience, and eye
care - and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram,
YouTube and LinkedIn.Job DescriptionAbbVie is looking for a
Principal Engineer to lead the Irvine Engineering Testing &
Analysis group (ETAG) within Combination Product Development (CPD).
This is a key role with a direct impact on AbbVie's exciting and
rapidly growing portfolio of combination products, with a major
focus on Eye Care and Neurotoxins products.The Principal Engineer
will direct project activities and professional development of a
group of testing engineers by effectively mentoring, guiding and
supervising personnel. He/she will serve as a technical lead on
his/her own projects while contributing engineering insights into
multiple other projects. Critical to this role will be the ability
to independently conceive, execute, and communicate novel
multi-disciplinary approaches and development strategies that
achieve project and area goals.Responsibilities:Effectively
function as a principal investigator for the Lab Testing function,
generating original technical ideas and strategies. Serve as
Technical Lead on one or more development projects.Demonstrate
creative 'out of the box' thinking to solve difficult problems and
champion new technologies to achieve project goals.Generate new
technical proposals and lead those efforts. Anticipate and
critically evaluate scientific or regulatory advances or
competitive threats and respond with appropriate new
strategies.Primary author of technical and regulatory documents
and/or primary inventor of patents.Mentor/supervise a team of one
or more and evaluate the performance of those individuals; is
accountable for the effective performance of the
team/individuals.Supervise the design and execution of experiments
supporting feasibility, development, and verification stages of
product development to meet project timelines and all relevant
regulatory compliance requirements.Contribute directly to technical
activities, including:Establish and maintain lab equipment/software
capabilities by authoring SOPs and qualification packages,
developing training, troubleshooting issues, and leading audit
reviews.Guarantee GMP compliant framework such as SOPs for the
overall Quality System, training requirements and
infrastructure.Define, develop, and validate/transfer test
methods.Create verification plans, protocols, records, and reports.
Support investigations and issue resolutions. Coordinate testing
across multiple test executors and manage test schedules.Analyze,
document, and present results to cross-functional teams. Ensure
scientific insights are leveraged across projects.Promotes
harmonized development strategies across CPD projects and
sites.Stimulate innovation and foster an inclusive and collegial
work environment.QualificationsA degree in an engineering field
(mechanical, materials, packaging, bioengineering): BS or
equivalent education and extensive, typically 14+ years of
experience; MS or equivalent education with typically 12+ years of
experience; PhD with typically 6+ years of experienceStrong
expertise in Design Verification for Medical Devices and experience
working in a regulated environment in compliance to 21 CFR 820 and
MDR.Significant background in engineering testing and analysis
including:Direct experience of test equipment validation (IQ, OQ,
PQ) is required.Expertise in statistical analysis.Significant
documentation experience including standard operating procedures
(SOPs), technical reports, and design verification
plans/protocols/reports. Expertise with Electronic Lab Notebooks
(ELN) and Design History File tools such as
Polarion/LinkUsDemonstrated effective people leadership -
deliverables produced on time, and personnel development plans in
effect.Recognized and sought out as an expert in his/her
discipline.Project management competencies in budgeting (External
Spend and Capital Expenditure) and resource planning as well as
scheduling and tracking of project tasks. Ability to manage
multiple, complex projects.Proficiency in MS Office, MS Project,
Solidworks.Lean Six Sigma, 5S experience desired.Good communication
skills, both written and oral. Ability to prepare technical reports
and presentations. Demonstrated scientific communication and
presentation skills, including the ability to present to senior
management.Willingness and ability to travel both domestic and
international up to 10% of the timeAdditional InformationApplicable
only to applicants applying to a position in any location with pay
disclosure requirements under state or local law: ---The
compensation range described below is the range of possible base
pay compensation that the Company believes in good faith it will
pay for this role at the time of this posting based on the job
grade for this position. Individual compensation paid within this
range will depend on many factors including geographic location,
and we may ultimately pay more or less than the posted range. This
range may be modified in the future.---We offer a comprehensive
package of benefits including paid time off (vacation, holidays,
sick), medical/dental/vision insurance and 401(k) to eligible
employees.---This job is eligible to participate in our short-term
incentive programs. ---This job is eligible to participate in our
long-term incentive programs---Note: No amount of pay is considered
to be wages or compensation until such amount is earned, vested,
and determinable. The amount and availability of any bonus,
commission, incentive, benefits, or any other form of compensation
and benefits that are allocable to a particular employee remains in
the Company's sole and absolute discretion unless and until paid
and may be modified at the Company's sole and absolute discretion,
consistent with applicable law. ---AbbVie is an equal opportunity
employer and is committed to operating with integrity, driving
innovation, transforming lives, serving our community and embracing
diversity and inclusion. It is AbbVie's policy to employ qualified
persons of the greatest ability without discrimination against any
employee or applicant for employment because of race, color,
religion, national origin, age, sex (including pregnancy), physical
or mental disability, medical condition, genetic information,
gender identity or expression, sexual orientation, marital status,
status as a protected veteran, or any other legally protected group
status.US & Puerto Rico only - to learn more, visit
https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS
& Puerto Rico applicants seeking a reasonable accommodation, click
here to learn
more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlSalary:
$117,500 - $223,500
Keywords: AbbVie, Rialto , PRINCIPAL ENGINEER, ENGINEERING TESTING & ANALYSIS (TEAM LEAD), Engineering , Irvine, California
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