{bc}
Apply
greenhouse

Associate Engineer I, Validation

Arrowhead Pharmaceuticals
Verona, USA
Mid
Onsite
USD 60000-70000 / year
Discovered Today

Full Job Posting

Requirements

  • Bachelor’s degree in Engineering or related scientific field
  • Strong communication and documentation skills
  • Proficient with Microsoft Office Suite
  • Preferred
  • 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.
  • Wisconsin pay range $60,000—$70,000 USD
  • Arrowhead provides competitive salaries and an excellent benefit package.
  • Candidates must have current, valid authorization to work in the country where this role is located.
  • California Applicant Privacy Policy

Preferred Qualifications

  • Preferred

Responsibilities

  • Creates C&Q and temperature mapping worksheets and protocols from site templates with oversight by management or senior team members.
  • Advances internal and external C&Q and equipment lifecycle documentation through the review and approval process.
  • Execute, or oversee vendor execution, for simple or routine qualification testing with Subject Matter Expert support. Identifies protocol events and investigates with manager support.
  • Completes qualification documentation following good documentation practices.
  • Prepares and reviews requirement trace matrixes and qualification reports from internal or vendor provided qualification protocols.
  • Participates on project teams to report status and meet project deliverables including qualification testing, and event resolution, and closure.
  • Develops ability to manage individual tasks against project schedule. Works with manager to prioritize commitments across projects.
  • Participates on teams during the preparation of system design and specification documents and supports updates with oversight from team members.
  • Supports completion of gap assessments for existing equipment qualifications in response to new products introduced into a manufacturing platform. Shares gaps with project team 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.
  • With management or team member oversight reviews simple equipment changes for impact to qualification, identifies actions needed, and completes requalification deliverables to support change completion.
  • Develops an awareness of qualification best practices and looks to apply a science and risk-based approach to C&Q.
  • Begins to understand qualification requirements for automated equipment and systems integrated with validated computer systems under guidance of senior team members.
  • Performs other related duties as assigned.

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Arrowhead Pharmaceuticals

Senior Director, Quality Control

Verona, USA

Discovered Today

Associate Director, Manufacturing Science and Technology

Verona, USA

Discovered Today

Analyst II, Cyber Security (Operational Technology)

Madison, USA

Discovered Today

Lead, Technical Transfer

Verona, USA

Discovered Today

Associate Director, Medical Value, Evidence, and Outcomes (MVEO)

Pasadena, USA

Discovered Today

Associate Scientist I, In Vivo Research

Madison, USA

Discovered Today

Metrology Technician ll

Verona, USA

Discovered Today

Team Leader, Raw Materials

Verona, USA

Discovered Today