Senior Packaging Engineer: Process & Validation Leader

Intellectt Inc; North Haven (CT); Presencial; USD 105.000 - 135.000; Jornada completa

Descripción de la vacante

Intellectt Inc. is seeking an experienced Senior Packaging Engineer to lead packaging process development, equipment qualification, and validation efforts in a regulated medical device environment.

You will ensure FDA and quality system compliance, collaborate across Manufacturing, Quality, Regulatory, and Engineering teams, and drive continuous improvement through Lean and Six Sigma methodologies. This role requires a Bachelor’s in a related field and 7+ years of experience.

Formación

• Bachelor’s degree in a relevant engineering discipline is required.
• 7+ years of Packaging Engineering experience, or an advanced degree with relevant experience.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
• Strong problem-solving, project leadership, and technical communication skills.
• Ability to collaborate effectively with cross-functional teams.

Responsabilidades

• Lead packaging process development and improvement activities.
• Perform packaging equipment qualification and process validation, including IQ/OQ/PQ.
• Collaborate with cross-functional teams to resolve manufacturing and production issues.
• Conduct root cause investigations and develop corrective and preventive actions (CAPA).
• Maintain technical documentation and support packaging validation activities.
• Ensure compliance with FDA regulations and applicable quality system requirements.
• Drive operational excellence through Lean Manufacturing and Six Sigma methodologies.
• Support continuous improvement initiatives across packaging and manufacturing operations.

Educación

Bachelor’s degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline

Descripción del empleo

Intellectt Inc. is seeking an experienced Senior Packaging Engineer to lead packaging process development, equipment qualification, and validation efforts in a regulated medical device environment.

You will ensure FDA and quality system compliance, collaborate across Manufacturing, Quality, Regulatory, and Engineering teams, and drive continuous improvement through Lean and Six Sigma methodologies. This role requires a Bachelor’s in a related field and 7+ years of experience.