Associate Engineer I, Validation

Arrowhead Pharmaceuticals•Verona, WI

1d•$60,000 - $70,000•Onsite

About The Position

The Associate Engineer I, Validation is an entry-level role supporting equipment, utility, analytical instrument, and facility qualification at Arrowhead’s Verona site. The position coordinates and executes commissioning and qualification (C&Q) activities for internal GMP drug substance manufacturing and testing. Work may support new systems, modifications to existing equipment, and periodic reviews. The role helps ensure that internal system specifications and quality standards are applied throughout the equipment lifecycle. The Associate Engineer I prepares and advances qualification documentation, performs or oversees routine qualification testing with subject matter expert support, and participates in project teams to deliver qualification work and resolve events. With guidance from management and senior team members, the employee supports increasingly complex systems and equipment, assesses the qualification impact of changes, and develops an understanding of qualification best practices and science- and risk-based approaches to C&Q.

Requirements

Bachelor’s degree in Engineering or a related scientific field.
Strong communication and documentation skills.
Proficiency with Microsoft Office Suite.

Nice To Haves

Prior experience or an internship in the pharmaceutical industry, preferably in validation or quality systems.
Prior experience with automated manufacturing equipment.
Familiarity with Blue Mountain Regulatory Asset Manager software.
Awareness of cGMP requirements.
Familiarity with engineering drawings such as P&IDs, piping, and electrical drawings.

Responsibilities

Create C&Q and temperature-mapping worksheets and protocols using site templates, with oversight from management or senior team members.
Advance internal and external C&Q and equipment lifecycle documentation through review and approval.
Execute, or oversee vendor execution of, simple or routine qualification testing with subject matter expert support; identify protocol events and investigate them with manager support.
Complete qualification documentation in accordance with good documentation practices.
Prepare and review requirement trace matrices and qualification reports based on internal or vendor-provided protocols.
Participate on project teams, report status, and meet deliverables related to qualification testing, event resolution, and closure.
Develop the ability to manage individual tasks against project schedules and work with a manager to prioritize commitments across projects.
Participate in preparing system design and specification documents and support updates with oversight from team members.
Support gap assessments for existing equipment qualifications when new products are introduced to a manufacturing platform; share gaps with the project team and help develop and execute action items.
Support senior team members in qualification activities for systems of increasing complexity, automated equipment, and systems integrated with validated computer systems.
Complete periodic reviews for simple equipment according to assigned schedules.
Review simple equipment changes with oversight, assess qualification impact, identify required actions, and complete requalification deliverables to support change completion.
Develop awareness of qualification best practices and apply a science- and risk-based approach to C&Q.
Begin learning qualification requirements for automated equipment and systems integrated with validated computer systems under senior team member guidance.
Perform other related duties as assigned.