Cleaning Validation & Commissioning Specialist

BioSpace; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking an engineering professional to plan and complete commissioning, qualification and validation activities for equipment, facilities, utilities, and processes. The role emphasizes risk management, regulatory alignment, and documentation to deliver high-quality products.

Responsibilities include developing test protocols, leading risk assessments, coordinating validation efforts, and mentoring junior staff while ensuring EH&S and compliance with company standards.

Qualifications

• Bachelor's degree in engineering or closely related field; 3+ years of engineering/operational experience.
• Experience in commissioning, qualification, validation and risk management deliverables.
• Experience in manufacturing/quality/engineering with Validation subjects.
• Strong interpersonal and communication skills; team oriented.

Responsibilities

• Develop and execute commissioning, qualification and validation test protocols.
• Support broader project leadership, developing operational procedures and training staff on new equipment or processes.
• Leads Execution of Risk Management, including RRAs and FMEA facilitation.
• Coordinate and review documentation, change requests, and validation support.
• Supervise junior or contract validation resources when needed.

Skills

Commissioning

Qualification

Validation

Risk Management

FMEA

Project Leadership

Documentation

Regulatory Compliance

Education

Bachelor's Degree in Engineering or related field

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

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.

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

• Develop and execute commissioning, qualification and validation test protocols.
• Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of staff/operators on new equipment or processes, reviewing new or modified product documentation to ensure compatibility with qualified equipment/process and implementing changes as necessary
• Leads Execution of Risk Management. including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team & 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.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
• Responsible for the coordination and the execution of the sampling related to cleaning validation following the established procedures and applicable protocols. Document the results obtained and completion of cleaning validation summary reports accurately as required.
• Generate and process change requests per the applicable procedures.
• Lead the implementation of special projects related to cleaning validation area.
• Prepare area reports and presentations as applicable.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EH&S) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

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 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.

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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys 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, https://www.abbvie.com/join-us/reasonable-accommodations.html