Senior Engineer, Validation Commissioning

BioSpace; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie in North Chicago, IL, seeks an engineering professional to plan and execute commissioning, qualification and validation of new or modified equipment, facilities, and processes. The role focuses on risk management, technical documentation and regulatory alignment to deliver robust, high-quality products.

Working with project owners and cross-functional teams, you will develop specifications, support FAT, identify risk controls and ensure traceability per validation plans, enabling

Qualifications

• Bachelor's Degree in Engineering, science, or related discipline; 3+ years of significant engineering/operational experience.
• Experience in commissioning, qualification, validation and risk management deliverables with regulatory scrutiny.
• 6+ years in Manufacturing, Quality or Engineering including 4 major validation subjects preferred.
• Technical background in healthcare, nutritional products, lab diagnostics, medical devices or pharmaceutical industries preferred.
• Strong interpersonal, communication, and negotiation skills with ability to work in a team.
• Knowledge of quality/compliance management and regulations affecting API, Bulk Drug or Finished goods manufacturing preferred.
• Ability to supervise junior or contract team members.
• Ability to manage multiple complex projects (5+) simultaneously.

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing in conjunction with Project Engineer.
• Identify risk controls and traceability based on FMEA or risk assessment.
• Develop and execute commissioning, qualification and validation test protocols.
• Troubleshoot issues and document unresolved items.
• Lead broader project aspects: leadership, operating procedures, training, reviewing documentation.
• Execute Risk Management per Validation Master Plan and assess change impacts.
• Supervise contract validation resources as needed.

Skills

Strong interpersonal skills

Effective communication

Negotiation skills

Project management

Education

Bachelor's Degree in Engineering or related discipline

Equivalent technical experience

Job 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.

Company Description

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 owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified 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 main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

Responsibilities

• Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
• Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
• Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications.
• Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
• Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
• Leads Execution of Risk Mngmnt. including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation.
• Qualification as QRM facilitator commensurate with responsibility.
• May supervise contract validation resources in the timely completion of activities in his/her 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 3+ years of significant engineering and/or operational experience.
• Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) 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
• Ability to supervise junior or contract team members (prior supervisory experience preferred)
• Ability to manage complex projects and multiple projects (5+) 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 roleat thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may be modified 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 isearned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat areallocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole and absolutediscretion, 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