Senior Process Engineer in Indianapolis

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Job Description

Job Responsibilities

• Monitor and analyze manufacturing and equipment performance data to drive continuous improvement and support investigations.
• Lead implementation and execution of standardized decontamination protocols across filling and packaging lines.
• Mentor team members on process improvements, sterilization technologies, equipment requalification, and aseptic practices.
• Lead technical investigations using structured problem-solving methodologies (e.g., DMAIC, root-cause analysis).
• Act as the primary technical representative on cross-functional teams to resolve deviations, equipment failures, and process challenges.
• Evaluate and integrate new technologies such as advanced sterilization or automated filling systems into GMP operations.
• Develop and author protocols, reports, technical rationales, and documentation supporting qualification, validation, and lifecycle activities.
• Adapt quickly to evolving client and production needs, including occasional support for 24/7 operations.

Job Requirements

• Minimum 5+ years of experience in a pharmaceutical manufacturing environment.
• Bachelor’s degree or higher in an engineering discipline.
• Strong background in pharmaceutical sterile manufacturing operations.
• Proven ability to communicate complex technical information clearly to cross-functional or non-technical audiences.
• Familiarity with data analytics, root-cause methodologies, and risk-based decision making.

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