New · posted Nov 11
AbbVie · Pharmaceuticals
Cleaning Validation & Commissioning Specialist
- North Chicago, IL
- On-site
- Full-time
- Senior & Principal
What you need
What you'll do
- 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.”
- 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.
- 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
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 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$85,000 – $162,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Short-term incentive program
Where you'll work
North Chicago, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in North Chicago, IL
From the posting
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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 applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,000 | — | $162,000 |
| All US (middle half) | $105,250 | $123,500 | $139,375 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 97 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification7
- Documentation and SOPs6
- Collaboration and leadership5
- Quality systems and risk4
- Lab testing and methods3
- Clinical trial conduct3
- GMP and compliance1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
AbbVie on Regulatory Jobs
- 74
- Open roles
- 74
- Distinct roles
- 17
- Locations
By discipline
- Clinical60 52%
- Quality29 25%
- Regulatory26 23%
By level
- Director52 45%
- Manager28 24%
- Senior & Principal20 17%
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Cleaning Validation & Commissioning Specialist at AbbVie
Open until filled. $85K–$162K a year, employer provided.