PRINCIPAL ENGINEER, ENGINEERING TESTING & ANALYSIS (TEAM LEAD)
Company: AbbVie
Location: Irvine
Posted on: October 14, 2024
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.Qualifications
- A 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 experience
- Strong 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/LinkUs
- Demonstrated 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, Santa Monica , PRINCIPAL ENGINEER, ENGINEERING TESTING & ANALYSIS (TEAM LEAD), Engineering , Irvine, California
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