Validation Engineer II

Job Title

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

• 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.

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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Pay Range: $75000 - 142500 USD

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.