Sr Principal Engineer, Process

AbbVie•Durham, NC

About The Position

The Sr Principal Engineer, Process leads technical workstreams and contributes to program outcomes by developing actionable methods and analyses, collaborating with cross-functional partners to integrate technical solutions throughout the lifecycle, and advising on complex technical decisions and risks. The role designs site-level processes and improvements by defining operating ranges, critical parameters, and acceptance criteria that support efficient, high-quality production. The position leads process improvement and optimization workstreams, including defining technical approaches, coordinating trials with production, and documenting results. It conducts process validation and troubleshooting for manufacturing processes by analyzing performance data, investigating deviations, and drafting corrective actions and supporting documentation for review and approval. It also establishes technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete. The engineer guides other engineers through technical decisions by running working sessions, documenting decision logic, and tracking actions to closure. The role delivers high-quality technical outputs for complex projects and programs, validates methods, documents results and assumptions, ensures adherence to applicable standards and controls, and communicates technical progress, impacts, and recommended mitigations to project leads and stakeholders. The position involves travel 10% of the time.

Requirements

  • Bachelor’s degree in an engineering discipline such as Mechanical, Electrical, or Chemical Engineering.
  • 8+ years’ experience in pharmaceutical industry formulation.
  • Knowledge of engineering standards.
  • Demonstrated leadership and team-building skills.
  • Strong problem-solving abilities.
  • Proven track record of managing projects through to completion.
  • Excellent communication skills with layers of management.

Responsibilities

  • Lead technical workstreams and contribute to program outcomes through actionable methods, analyses, cross-functional collaboration, and advice on complex technical decisions and risks.
  • Design site-level processes and improvements by defining operating ranges, critical parameters, and acceptance criteria for efficient, high-quality production.
  • Lead process improvement and optimization workstreams, define technical approaches, coordinate trial execution with production, and document results.
  • Conduct process validation and manufacturing-process troubleshooting by analyzing performance data, investigating deviations, and drafting corrective actions and supporting documentation for review and approval.
  • Establish technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete.
  • Guide engineers through technical decisions, run working sessions, document decision logic, and track actions to closure.
  • Deliver technical outputs for complex projects and programs; define and validate methods, document results and assumptions, ensure adherence to applicable standards and controls, and communicate progress, impacts, and recommended mitigations to project leads and stakeholders.

Benefits

  • Paid time off, including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance.
  • 401(k).
  • Eligibility to participate in long-term incentive programs.
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