Senior CQV Engineer - GMP Automation & Validation

Katalyst Healthcares & Life Sciences; Newark (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst Healthcares & Life Sciences seeks a Sr. Engineer – Process Development (CQV) to lead commissioning, qualification, and validation of automated and semi-automated packaging equipment in a GMP FDP manufacturing environment.

You will author IQ/OQ/PQ protocols, maintain Master Validation Plans, and serve as the technical SME for automated systems, labeling, and packaging validation, collaborating with Engineering, Quality and Manufacturing.

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• Proven experience in CQV within a GMP-regulated manufacturing environment.
• Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations.

Responsibilities

• Lead commissioning, qualification, and validation activities for automated and semi-automated equipment and processes.
• Author, review, and execute IQ/OQ/PQ protocols and related validation documents.
• Maintain Master Validation Plans and ensure GMP/FDA compliance.
• Act as technical SME for automated systems, labeling, and packaging validation.

Skills

CQV experience

GMP knowledge

Validation documentation

Education

Bachelor's or Master's degree in Engineering/Life Sciences

Tools

Kneat software

Job description

Katalyst Healthcares & Life Sciences seeks a Sr. Engineer – Process Development (CQV) to lead commissioning, qualification, and validation of automated and semi-automated packaging equipment in a GMP FDP manufacturing environment.

You will author IQ/OQ/PQ protocols, maintain Master Validation Plans, and serve as the technical SME for automated systems, labeling, and packaging validation, collaborating with Engineering, Quality and Manufacturing.