Associate Engineer I, Validation

About the Role

The Associate Engineer I, Validation is an entry-level position providing support for equipment, utility, analytical instrument, and facility qualification at the Arrowhead Verona site.

Key Responsibilities

• Creates C&Q and temperature mapping worksheets and protocols from site templates with oversight.
• Advances internal and external C&Q and equipment lifecycle documentation through the review and approval process.
• Executes, or oversees vendor execution, for simple or routine qualification testing with Subject Matter Expert support.
• Investigates protocol events with manager support.
• Completes qualification documentation following good documentation practices.
• Prepares and reviews requirement trace matrixes and qualification reports.
• Participates on project teams to report status and meet project deliverables.
• Develops ability to manage individual tasks against project schedule and prioritizes commitments.
• Participates on teams during the preparation of system design and specification documents and supports updates.
• Supports completion of gap assessments for existing equipment qualifications in response to new products.
• Shares gaps with project teams to develop and execute action items.
• Supports senior team members in execution of qualification activities for systems of growing complexity, automated equipment, and systems integrated with validated computer systems.
• Responsible for completion of periodic reviews for simple equipment per assigned schedules.
• Reviews simple equipment changes for impact to qualification and completes requalification deliverables.
• Develops an awareness of qualification best practices and applies a science and risk-based approach to C&Q.
• Understands qualification requirements for automated equipment and systems integrated with validated computer systems under guidance.
• Performs other related duties as assigned.

Requirements & Tech Stack

• Bachelor’s degree in Engineering or related scientific field.
• Strong communication and documentation skills.
• Proficient with Microsoft Office Suite.
• Prior experience or internship in the pharmaceutical industry, preferably with validation or quality systems.
• Prior experience with automated manufacturing equipment.
• Familiar with Blue Mountain Regulatory Asset Manager software.
• Awareness of cGMP requirements.
• Familiar with engineering drawings such as P&IDs, piping, and electrical drawings.