Senior Engineer, Validation

The Senior Validation Engineer for Facilities Utilities & Equipment (FUE) Qualification is responsible for leading planning executing and maintaining qualification/validation activities at AbbVies manufacturing site. This role ensures that all systems are installed commissioned qualified and maintained in compliance with regulatory requirements internal quality standards and industry best practices.

The successful candidate will serve as the subject matter expert (SME) for equipment facility and utility validation lead cross-functional projects and drive continuous improvement in validation strategies and lifecycle management.

This position is fully onsite Monday-Friday. Open to considering non-local candidates; relocation required. 

Responsibilities:

• Lead and execute qualification activities for facility utilities and equipment including but not limited to temperature-controlled chambers water for injection clean steam process tanks and autoclaves.
• 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 the risk assessment.
• Develop review and approve validation protocols such as URS FRS DQ IQ OQ PQ protocols as well as summary reports.

• Lead and document troubleshooting efforts of issues encountered during commissioning and qualification.
• Ensure risk-based validation approaches following current industry guidelines (e.g. GAMP 5 ASTM E2500 ISO FDA EMA).
• Support projects ensuring validation requirements are integrated into project deliverables and timelines are met.
• Coordinate with Engineering Quality Assurance Operations and Maintenance to support commissioning start-up and qualification activities.
• Maintain validation status of systems through the execution of Periodic Reviews Requalifications and Change Controls.
• Maintain Validation Master Plans as appropriate. Participate in Validation Review Board meetings. Responsible for Validation Change Control documentation.
• Support regulatory inspections and internal audits related to equipment utility and facility qualification.

Qualifications :

Qualifications

• Bachelors Degree a BS in an engineering discipline required 
• 5 years combined work experience in validation and/or engineering positions within the pharmaceutical area.
• Knowledge/experience in creating and executing validation documents.
• General understanding of pharmaceutical equipment.

Preferred: 

• Experience with clean utilities (e.g. WFI PW Clean Steam) facility monitoring systems and critical environment controls.
• Experience in the development of commissioning qualification validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• Experience in Manufacturing including 5 major validation subjects.
• Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.
• Strong knowledge of qualification and validation lifecycle principles and applicable regulatory guidelines (FDA EMA ICH Q7/Q9/Q10 GAMP 5 ASTM E2500).
• Sterile manufacturing qualification experience preferred.
• Quality System Experience such as Veeva Trackwise ComplianceWire.
• Ability to manage complex projects and multiple projects (5) simultaneously.
• Strong interpersonal communication and negotiation skills with demonstrated ability to work within a team environment.
• Hands-on experience with FUE systems and process equipment qualification.
• Excellent technical writing analytical and problem-solving skills.
• Experience with computerized system validation (CSV) and automation platforms.

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 employee remains in the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time