The Engineer I, Validation will manage and execute commissioning, qualification, and validation (CQV) activities supporting internal GMP drug substance manufacturing at the Arrowhead Verona site. This may include CQV programs for equipment, instruments, utilities, facilities, and processes. The Engineer I is responsible for ensuring external and internal quality standards are applied and followed.

Responsibilities

Creates and maintains site Validation Master Plans, CQV protocols/procedures and templates for equipment qualification and lifecycle management based on a science and risk-based approach. Leads cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced.

Assists with preparation and maintenance of User Requirements Specifications.

Prepares and executes installation/operation/performance qualification protocols for new and existing pharmaceutical manufacturing equipment, utilities, and automation systems. Responsible for management of study completion with subject matter expert support.

Provides Validation oversight for Manufacturing, Engineering, and Metrology with development of process validation, cleaning validation, and instrument qualification studies.

Prepares and reviews CQV reports.

Reviews proposed changes for impact to system qualification and validation. Identifies and completes requalification activities to support change completion.

Maintains internal records for tracking requalification activities. Responsible for completion of periodic reviews per assigned schedules.

Maintains qualification documentation in a state of GMP compliance and supports licensee/partner and regulatory site audits.

Identifies and proposes process improvement ideas.

Collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, qualification testing, and deviation resolution.

Performs other related duties as assigned.

Requirements: years of experience in a validation engineering role, preferably in the pharmaceutical drug substance manufacturing industry Ability to read and understand engineering drawings such as P&IDs, electrical drawings, and functional specifications.

Bachelor’s degree in Engineering or related scientific field

Thorough understanding of cGMP and FDA requirements

Strong communication and documentation skills

Proven project management skills

Experience with equipment qualification following ISPE and ASTM guidelines.

Proficient with Microsoft Office Suite

Preferred

Prior experience with qualification of equipment integrated with process control systems and qualification of shared equipment in a multi-product facility. Prior experience implementing concepts in ISPE Baseline Guide , Volume for equipment qualification.

Familiar with software validation following a computer software assurance (CSA) model.

Prior experience with cleaning and process validation for the pharmaceutical industry.

Familiar with Blue Mountain Regulatory Asset Manager software.