New · posted Nov 10
AbbVie · Pharmaceuticals
QA Validation Engineer
- Irvine, CA
- On-site
- Full-time
- Associate & Specialist
The role
Under the direction of the Validation Section Manager and guidance from senior validation personnel, this individual executes assigned validation activities, prepares and reviews validation documentation, supports routine requalification activities, and helps maintain the validated state of systems at the plant. This role applies established procedures, escalates issues appropriately, and develops validation knowledge while contributing to the effectiveness of the Quality System.
What you need
What you'll do
Main responsibilities for this role include assigned execution, documentation, and support activities, with guidance from management or senior validation personnel as needed.
- Participate in the implementation and maintenance of validation programs and Quality System requirements to meet applicable regulatory and company standards.
- Follow approved practices and procedures to help ensure compliance with company policies, cGMP, and applicable regulations for assigned validation activities.
- Execute assigned tasks that support the Validation Master Plan and help maintain the validated state of equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, sterilization processes, and laboratory instruments.
- Support investigations of validation discrepancies or failures by gathering information, documenting results accurately, and assisting with corrective and preventive actions under supervision.
- Participate with plant, engineering, quality, laboratory, and external resources on new installations or system changes to help ensure commissioning and qualification documentation supports cGMP expectations.
- Support routine qualifications and requalifications by preparing materials, coordinating assigned activities, executing protocols, and helping ensure completion in a timely manner.
- Draft and revise validation-related documents such as protocols, reports, lifecycle documents, user requirements, system classifications, risk assessments, and procedures for review and approval by senior staff or management.
Required and preferred qualifications for this role include education, foundational technical skills, and relevant early-career experience.
- Bachelor's degree, preferably in Biology, Chemistry, Engineering, or a related scientific discipline; equivalent relevant experience may be considered where appropriate.
- 2+ years of overall experience in Manufacturing, Quality, Engineering, Validation, or a related regulated environment preferred.
- Good verbal and written communication skills, with the ability to document work clearly and accurately.
- Good problem-solving and analytical skills, with the ability to escalate issues and seek guidance when needed.
- Good interpersonal and cross-functional communication skills.
- Basic knowledge of quality systems, compliance expectations, cGMP, data integrity, and regulations or standards affecting API, bulk drug, or finished goods manufacturing preferred.
- Familiarity with cGMP systems such as RAM, Maximo, KNEAT, TrackWise, and Veeva Vault is a plus.
- Experience with Temperature mapping devices, such as Kaye, Ellab, and Temptales preferred.
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
$66,000 – $126,000 a year
Employer providedPaid time off
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CA
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.
Purpose:
The Validation Engineer supports the development and maintenance of validation activities for facilities, utilities, equipment, systems, processes, cleaning processes, and laboratory instruments in accordance with company standards, health authority regulations, cGMP, and site procedures.
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 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 25% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $66,000 | — | $126,000 |
| All US (middle half) | $67,500 | $77,000 | $91,250 |
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 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 96 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 qualification9
- Documentation and SOPs7
- GMP and compliance4
- Quality systems and risk4
- Lab testing and methods3
- Data and digital systems2
- Clinical trial conduct2
- Collaboration and leadership2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- 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 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
- 72
- Open roles
- 72
- Distinct roles
- 17
- Locations
By discipline
- Clinical62 54%
- Quality28 25%
- Regulatory24 21%
By level
- Director55 48%
- Manager25 22%
- Senior & Principal19 17%
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QA Validation Engineer at AbbVie
Open until filled. $66K–$126K a year, employer provided.