Senior Validation Engineer
About this opportunity
Company 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
We are hiring a Senior Business Systems Validation Engineer to join AbbVie Cork. This role focuses on validation and technical support for manufacturing business systems, particularly MES support for SAP and POMSnet. You will also lead validation activities for the implementation of these systems within the manufacturing environment. In addition, you will support new technology introduction, process improvement, GMP compliance, and troubleshooting throughout the commercial product lifecycle.
What You’ll Do
Support validation and production activities for MES systems e.g. EBR and SAP, including system upgrades, issue resolution, continuous improvement, and ongoing production support.
Support SAP and MES activities for new product introductions, including creation of new materials, BOMs, recipes, and system validation.
Maintain data integrity and data security risk assessments, including support for remediation of legacy systems.
Support product lifecycle activities, including SOP updates, investigations, study plans, protocols, reports, change plans, annual product reviews, and batch record updates.
Support the introduction of new products and new technologies, including equipment selection, validation, training, and process support.
Provide validation guidance for automation and business systems changes, including suitability assessments and VRB assessments where applicable.
Write and execute validation protocol for , cleaning, equipment, utilities, facilities, automation and process.
Support change control activities, validation documentation review and approval, and cross-functional project groups.
Support audit readiness and participate in GMP, corporate, and supplier audits.
Maintain compliance with cGMP, FDA, IMB, GxP, safety, and environmental requirements.
Actively contribute to AbbVie’s operational excellence and digital transformation goals by embracing AI tools, data-driven decision-making, and continuous improvement practices.
Comply with all applicable health, safety, and environmental policies, procedures, and regulations.
Qualifications
Bachelor’s degree in Engineering, Science, or a related discipline preferred, or equivalent relevant experience.
5–10 years’ experience in MES/automation systems validation, new product introduction, and/or manufacturing support within a pharmaceutical or GMP-regulated environment.
Experience with laboratory and manufacturing equipment validation, computer system validation, GAMP 5, and EU Annex 15.
Knowledge of process performance qualification, cleaning validation, hold time studies, and validation lifecycle activities.
Experience supporting ERP SAP systems and MES/EBR implementation.
Familiarity with data historians such as OSI PI and reporting tools is an advantage.
Strong project management, problem-solving, and communication skills.
Ability to work independently and as part of a team, with good people management skills and strong organizational capability.
Comfortable working under pressure, prioritizing workload, and meeting tight deadlines.
Additional Information
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, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 256 comparable Senior Quality roles across 66 biopharma companies.
Salary context
66 of 256 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 256 comparable roles
+ 24 more countries
Seniority mix
256 of 256 peers have a known seniority level
Therapeutic area mix
0 of 256 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.