Qualification Engineer

Responsibilities:

Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and all other regulatory requirements including GAMP5.

Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.

Compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements.

May also investigate and troubleshoot problems that occur and determine solutions.

Coordinates and executes validation change control and preparation of draft protocols, reports, and data tables.

Maintains all documentation pertaining to validation.

Will assist in developing procedures and/or protocols.

Coordinates contract personnel through the completion of assignments.

Participates in cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required. Requirements:

Understanding and application of validation principles, concepts, practices, and standards.- 8+ years.

Working knowledge of current Good Manufacturing Practices (GMPs).

Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.

6+ years of qualifying infrastructure and OT networks.

Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.

Strong verbal, written, and interpersonal communication skills.

Proficient in Microsoft Office applications.