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Company Description
AbbVie’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 Description
Responsibilities:
• Lab Equipment SME: Owner and technical representative for GMP and non-GMP test equipment used for combination product development and Design Verification. Responsible for equipment qualification, equipment SOPs and work instructions, resolving equipment issues, training operators, and coordination of equipment use schedules.
• Lab Support: Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Experience using Zwick (UTM), machine shop equipment, 3D printers is required. Familiarity with fixture development, volumetric accuracy equipment, viscometers, climate chambers, etc. is a plus.
• Test Methods: Develop, validate, and transfer test methods.
• Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.
• Software Tools: Experience with Solidworks, Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred. Experience with Minitab and Matlab is a plus.
• Work in an independent manner under the guidance of a supervisor or technical lead.
• Complies with applicable policies and procedures, regulatory and safety requirements.
Qualifications
• Significant experience with operation and maintenance of a Universal Test Machine (UTM), preferably Zwick
• Experience with machine shop equipment including 3D printers, bandsaws, milling equipment, lathes, and lasers.
• Experience with equipment including computer numerical control (CNC) and automated features is a plus
• Strong communication skills (both written and verbal) including the ability to influence without direct authority and ability to present to auditors on equipment qualification and data integrity.
• Knowledge of Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations.
• Documentation experience including technical reports, design verification plans, protocols, etc.
• Strong understanding of engineering fundamentals with strong problem solving and analytical skills.
• Knowledge in basic statistics and Six Sigma statistical techniques is a plus.
• Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams, strong decision making, and completing quality deliverables on time.
• BS in Mechanical, or Biomedical Engineering with 8+ years of experience or MS with 6+ years of experience (MS preferred)
• 3+ years of experience in medical device or combination products is required.
Additional Information
Applicable 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.
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.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
