Validation Engineer II

An engineering professional that works with project engineers stakeholders and other project team members to complete tasks associated with commissioning and qualification of new or modified equipment facilities and utilities. The main objective of commissioning is to ensure the safe and orderly handover of the unit from the constructor to the owner guaranteeing its operability in terms of performance reliability safety and information traceability. When executed in a planned and effective way commissioning normally represents an essential factor for the fulfillment of schedule costs safety and quality requirements of the project.

Responsibilities

• Develop Execute and Implement Validation Documentation - Specification documents SOPs IQ/OQ/PQ equipment validation protocols re-qualifications and prepare applicable documents (functional requirements plans and final validation reports) to be compliant with applicable regulatory requirements internal company standards and industry practices. 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.
• Support site Cleaning Validation program.
• 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 :

• Bachelors 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

Bachelors 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 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:

Work :

No

Employment Type :

Full-time