Senior Process Engineer - GMP Validation & Equipment

Abbvie

Jersey (AR)

On-site

USD 90,000 - 130,000

Full time

11 days ago

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Job summary

AbbVie is seeking a Senior Process Engineer to provide technical support across cross-functional teams, oversee process validation and equipment qualification, and drive manufacturing improvements from concept through project closure. The role emphasizes GMP compliance and collaboration with development and operations on new products.

The ideal candidate has a strong engineering background, 5+ years of experience, and expertise in data analysis, SPC, and qualification protocols.

Qualifications

Bachelor's degree in Engineering, Science or closely related discipline; 5+ years of significant engineering/operational experience.
Has demonstrated competency within a discipline and strong technical knowledge.
Interacts well with diverse groups within engineering and maintains relationships with internal and external collaborators.
Excellent written and verbal communication; capable of presentations.
Experience in medical devices, pharmaceutical, biologics or similar industries.
Experience with financial systems and fiscal control.

Responsibilities

Lead process engineering activities in the product line, including validation and equipment qualification (IQ/OQ/PQ).
Troubleshoot production issues using data analysis and SPC tools to reduce losses and improve yield.
Support Engineering Change Orders and supplier changes with updated specs and training.
Design and develop equipment/fixtures for manufacturing, including in-house or vendor solutions.
Assist in integrating new products into manufacturing and advise on materials, processes, and cost aspects.
Validate new and revised manufacturing processes and ensure compliance with company standards.
Design and execute engineering studies to test hypotheses and drive project outcomes.