Engineer, Validation Commissioning

BioSpace; North Chicago (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

AbbVie seeks an engineering professional to plan and execute commissioning, qualification, and validation of automated systems, facilities, utilities, and processes in alignment with regulatory and quality requirements. You will design robust evaluation, testing, and documentation strategies while optimizing workflows for reliable manufacturing operations.

Responsibilities include developing specs, performing FAT, identifying risk controls via FMEA, and executing validation protocols.

Qualifications

• Bachelor's degree in Engineering or related field; 1+ years of significant engineering/operational experience.
• Experience developing commissioning, qualification, validation, or risk deliverables.
• Experience with Computer System Validation (CSV) is required.
• 2+ years in Manufacturing, Quality or Engineering with 2 major validation subjects preferred.
• Experience with automation systems, controls, PLC/SCADA, instrumentation.
• Healthcare/pharma industry background preferred.
• Strong interpersonal, communication, and teamwork skills.
• Ability to manage multiple projects (3+) simultaneously.

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
• Support Factory Acceptance Testing and verification activities to confirm facility and utility systems meet defined requirements prior to site deployment.
• Identify risk controls, critical elements, and traceability based on FMEA or risk assessments for qualified facilities and utility systems.
• Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC systems, and environmental/viable monitoring systems.
• Perform minor troubleshooting during commissioning including control logic, integration, instrumentation, documentation, and qualification deliverables.
• May support project activities such as leadership, SOPs, training, and documentation reviews; implement changes to equipment parameters or settings.
• Support risk management activities, including review per Validation Master Plan and interface with best practices; may perform FMEA facilitation.

Skills

Automation systems

PLC/SCADA

Instrumentation

Team collaboration

Regulatory knowledge

Risk management

Education

Bachelor's degree in Engineering/related field

Tools

CSV

FMEA

Job description

About AbbVieAbbVie'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.

Company DescriptionAbbVie\'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 owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modifiedautomated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level.The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows that support reliable and compliant manufacturing operations

Responsibilities

• Work with end users, project engineers, and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
• Support Factory Acceptance Testing and related verification activities to confirm facility and utility systems meet defined requirements prior to site deployment.
• Identify risk controls, critical elements, and traceability of design requirements based on FMEA or other risk assessment approaches for qualified facilities and utility systems.
• Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC systems, and environmental/viable monitoring systems to ensure performance against specifications and intended use.
• Perform minor troubleshooting of issues encountered during commissioning, including control logic, integration, instrumentation, documentation, and qualification deliverables.
• May support project activities such as project leadership, development of operational procedures, training of maintenance/technical staff/operators on new equipment and utilities, reviewing new or modified documentation for compatibility with qualified systems, and implementing changes to equipment parameters or facility-related settings.
• Support execution of risk management activities, including periodic review and update per the Validation Master Plan, interface with best practices and ccRA, and understanding of risk management principles, trace controls, change impact assessments, and rating scales. May perform FMEA authorization/facilitation as needed.
• May serve as a QRM facilitator commensurate with responsibility.
• Work with contract validation resources as part of a team to support timely completion of qualification activities within assigned area of responsibility.

Qualifications

• Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 1+ years of significant engineering and/or operational experience
• Experience in the development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• Experience with Computer System Validation (CSV) is required.
• 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
• Experience working withautomation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls strongly preferred.
• A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
• Works with junior or contract team members as part of a team
• Ability to manage multiple projects (3+) simultaneously

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,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Companys 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.

US & Puerto Rico only - to learn more, visithttps://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