Validation Engineer II

Responsibilities

• Develop, Execute and Implement Validation Documentation
• Technical review of Validation Documents.
• Execution of qualification and requalification protocols including autoclave and control temperature units within the QC Laboratory and Production areas using the Kneat paperless qualification system.
• Independently plans and conducts small to medium size assigned projects across various types of validation/qualification including facilities, utilities, equipment, and automation systems.
• Manages multiple, often concurrent, projects and meets deadlines and balances multiple demands.
• Process and complete EWR / EIR Records in the CMMS.
• Support equipment release using the CMMS system and associated procedures.
• Support Quality Investigations (Investigations and Corrective and Preventative actions (CAPA) and collaborating with quality and manufacturing in the root cause verification and corrective action implementation).
• Process and complete work order demand maintenance review and new equipment installation records in the CMMS (Computer Maintenance Management System) according to the site procedures.

Qualifications

• Bachelor’s degree in engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
• A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Experience in the development of commissioning and qualification deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• A basic understanding of government regulations such as FDA cGMPs.
• Preferred: Bachelor’s degree in engineering, science or computer science is Highly Desired. 3+ years validation experience writing and executing (IQ/OQ/PQ) with systems and equipment on the shop floor is Highly Desired. Experience with cGMP in a Pharmaceutical or Medical Device industry is Highly Desired. Knowledge of clean validation, temperature mapping, control temperature unit (autoclave and freezer) is Highly Desired.

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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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