Senior, Quality Engineer Equipment Validation (Hybrid)
Senior, Quality Engineer Equipment Validation (Hybrid)
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Salary Not Disclosed
1 Vacancy
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 GMPregulated 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 crossfunctional teams or change initiatives.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
