Validation Engineer II

AbbVie; Branchburg Township (NJ); On-site; USD 75,000 - 142,500; Full time

Benefits offered by this job

Short-term incentive programs

Comprehensive benefits including PTO

401(k)

Job summary

AbbVie is seeking an engineering professional to support commissioning and qualification of equipment, facilities, and utilities. The role ensures safe handover, operability, and traceability to meet schedule, cost, safety, and quality goals.

The role involves developing validation documents, executing IQ/OQ/PQ protocols, and managing multiple projects while coordinating with QA and manufacturing. BS in engineering or related field preferred; 3+ years of relevant experience.

Qualifications

• Bachelor’s degree in engineering, science, or closely related discipline required or equivalent technical experience.
• Experience developing commissioning and qualification deliverables with regulatory scrutiny in pharma/medical devices.
• Strong interpersonal, communication, and negotiation skills; team oriented.

Responsibilities

• Develop, Execute and Implement Validation Documentation - Specifications, SOPs, IQ/OQ/PQ protocols and validation reports.
• Execute qualification and requalification protocols including autoclave and temperature control units in QC and Production areas using Kneat.
• Plan and conduct small to medium validation/qualification projects across facilities, utilities, equipment, and automation systems.
• Process and complete EWR/EIR records in the CMMS and support equipment release procedures.
• Support Quality Investigations and CAPA with root cause verification and corrective actions.
• Support site Cleaning Validation program and CMMS-based work order reviews.

Skills

Validation documentation

Education

Bachelor’s degree in engineering, science, or closely related discipline

3+ years of significant engineering and/or operational experience

Tools

Kneat paperless qualification system

Job description

• Compensation: USD 75,000 - USD 142,500 - yearly

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

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’sdegree in engineering, science or computer scienceis 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 isHighly 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 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified 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 toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s 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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