Validation Engineer II

PowerToFly; New Jersey; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits package

401(k)

Short-term incentive programs

Paid time off

Job summary

The ideal candidate will have a engineering or science background with 3+ years of experience, strong teamwork, and knowledge of FDA cGMPs, in a US-based setting.

Qualifications

• Bachelor’s degree in engineering, science, or closely related discipline is desired, or equivalent technical experience with 3+ years of engineering/operational experience.
• Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Experience developing commissioning and qualification deliverables including specifications and testing protocols for regulatory scrutiny.
• Strong interpersonal, communication, and negotiation skills with ability to work in a team.
• Basic understanding of government regulations such as FDA cGMPs.

Responsibilities

• Develop, execute and implement validation documentation including specifications, SOPs, IQ/OQ/PQ, and final validation reports to comply with regulatory requirements and internal standards.
• Execute qualification and requalification protocols including autoclave and control temperature units in QC Lab and Production areas using Kneat paperless system.
• Independently plan and conduct small to medium projects across validation/qualification types and manage multiple deadlines.
• Process and complete EWR / EIR records in CMMS and support equipment release.
• Support Quality Investigations and CAPAs with root cause verification and corrective action implementation.
• Support site Cleaning Validation program and CMMS work order reviews.

Skills

Interpersonal skills

Communication

Negotiation skills

Regulatory knowledge (FDA cGMPs)

Technical writing

Education

Bachelor’s degree in engineering/science

Job description

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,XandYouTube.

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

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

• 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 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.