Senior Quality Engineer

United Pharma; Connecticut; On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma is seeking a Quality Engineer to support packaging validation and manufacturing quality activities across regulated environments.

You'll execute IQ/OQ/PQ, validate post-sealing/packaging equipment, and maintain QMS compliance while supporting audits. The role includes statistical analysis, CAPA investigations, and driving continuous improvement with cross-functional teams in a fast-paced setting.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of experience in Quality Engineering, Manufacturing Quality, Process Engineering, or Validation.
• Experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing environments preferred.

Responsibilities

• Support packaging validation and manufacturing quality activities
• Execute equipment qualification and process validation (IQ/OQ/PQ)
• Validate post-sealing and packaging equipment
• Maintain QMS compliance and support regulatory audits
• Perform statistical analysis and process capability studies
• Manage nonconformances, deviations, CAPA, and root cause investigations
• Develop inspection and testing procedures
• Drive continuous improvement and lean manufacturing initiatives
• Collaborate with Quality, Manufacturing, and Engineering teams

Skills

Quality Engineering

Manufacturing Quality

Process Engineering

Validation

Education

Bachelor’s degree in Engineering, Life Sciences, or a related technical field

Job description

• Support packaging validation and manufacturing quality activities
• Execute equipment qualification and process validation (IQ/OQ/PQ)
• Validate post-sealing and packaging equipment
• Maintain QMS compliance and support regulatory audits
• Perform statistical analysis and process capability studies
• Manage nonconformances, deviations, CAPA, and root cause investigations
• Develop inspection and testing procedures
• Drive continuous improvement and lean manufacturing initiatives
• Collaborate with Quality, Manufacturing, and Engineering teams

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field
• 5+ years of experience in Quality Engineering, Manufacturing Quality, Process Engineering, or Validation
• Experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing environments preferred