Computer Validation Engineer

Actavis is a strong leader in the development, manufacture and sales of first-class generic pharmaceuticals with operations in 32 countries, products registered in more than 60 countries, a robust development pipeline and an aggressive acquisition strategy.

 

This position requires an overall knowledge of pharmaceutical operation, cGMP’s, computer hardware and software and 21CFR Part 11 compliance. In addition, the incumbent must be capable of working proactively with individuals at all levels within the organization and be willing to take a lead role in driving software implementation projects to closure. The Computer Validation Engineer must possess the knowledge to question proposed changes, while adherence to established timelines and budgets. Additionally the engineer will be responsible for authoring validation deliveries such as strategy documents, requirements, protocols and final reports for computer based systems. This position may require scheduling and execution of activities during evening/weekend hours for certain projects.

 

Key Responsibilities: 



 

·  Write validation strategy documents, protocols and reports for computer systems. Execute validation protocols.

·  Review and summarize validation results.

·  Author, review, and approve operating and validation procedures related to Computer systems.

·  Maintain current systems in a cGMP complaint manner and evaluate impact of computer change requests on the validated state of the system.

·  Maintain CIS inventory of computer systems at the facility.

·  At times, perform assessments of existing computer systems for compliance with 21 CFR Part I and corporate policies. Develop validation plans for computer systems remediation. Develop and implement validation deliverable/activity timelines, ensuring commitments are met and reporting validation project status to management.

·  Maintain site alignment with Actavis corporate policies/procedures for CIS validation.

·  Interface with User Groups to establish software intent of use requirements.

·  Provide training on protocols and SOPs.

·  Participate as needed in inspections by regulatory agencies.

·  Provide guidance regarding deviations that occur during validation testing.

·  Complete/maintain up-to-date GMP and Technical training as per job curricula.

Requires experience in one of the following areas:

 

·  Computer systems (MS Windows OS, Networking)

·  Change Control

·  Computer Validation

·  Laboratory testing methodology

·  Microsoft Project, Visio and Excel, cGMPs

·  BS/BA preferred

·  3 years pharmaceutical experience

 

 

Actavis offer a competitive salary and comprehensive benefits package to all eligible employees.  For consideration, e-mail your resume, in a WORD document,  and current compensation information to:  recruiter@actavis.com .  Subject line MUST indicate Code:  CompValiEng/EP.

 

Actavis is an Equal Opportunity Employer and appreciates diversity in our workforce.