Senior, Quality Engineer Equipment Validation (Hybrid)

Job Details

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 . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok .

Job Description

Purpose

To provide Quality oversight and approval for Quality Engineers on qualification/validation activities and documentation.

Responsibilities:

Provide interpretation and guidance regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization.

Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.

Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.).

Support CAPA activities related to validation and qualification

Provide guidance, direction, and support to peers.

Provide assurance that applicable national and international regulatory requirements are adhered to in the context of validation and qualification policies, processes, and procedures.

Lead or participate on process improvement projects and assist with the development of compliance plans and strategies.

Review new / updated regulations and provide comments on and assessments of how the new / updated regulations impact the organization.

Participate in preparation and execution of authority inspections, self- inspections, vendor audits, presentation of validation concepts and system validations.

Represent R&D QA in cross functional global expert teams, industrial and professional associations. This role is a hybrid role with onsite in Lake County, IL.

Qualifications

4 year college degree; preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology.

Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance.

Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, Data Integrity, etc.)

Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, and Test Method validation.

Excellent communication capabilities and teamwork capacities.

Proven ability to work in a global environment and on virtual teams.

Experience leading cross-functional teams or change initiatives. Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible to participate in our short-term incentiveprograms.

This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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