Sr Engineer- Process Development (CQV)

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

Job-ID32258797Reference26-00593

Job Summary:

We are seeking a highly skilled Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. The role involves leading commissioning, qualification, and validation activities for both new and existing equipment and processes, ensuring compliance with FDA regulations and internal quality standards. The Sr. Engineer will serve as the site's technical expert for automated systems and combination product validation, collaborating closely with Engineering, Quality, and Manufacturing teams.

Roles & Responsibilities:

• Lead commissioning, qualification, and validation activities for automated and semi-automated combination product equipment and processes.
• Author, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain and manage Master Validation Plans and related documentation to ensure compliance with GMP and FDA regulations.
• Serve as the technical SME for automated systems, labeling, and packaging process validation.
• Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure robust and validated systems supporting 24/9 production operations.
• Conduct on-site and off-shift validation activities as needed to support continuous manufacturing operations.
• Identify process gaps and recommend improvements to optimize validation and operational efficiency.
• Support regulatory audits and inspections by providing accurate and complete validation documentation.

Education & Experience:

• Bachelor's or Master's degree in Engineering, Life Sciences, or related technical field.
• Proven experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated manufacturing environment.
• Hands-on experience with automated and semi-automated equipment, labeling, and packaging operations.
• Strong knowledge of FDA regulations, GMP standards, and internal quality systems.
• Experience with validation documentation including Master Validation Plans, IQ/OQ/PQ protocols, and reports.
• Familiarity with Kneat software is a plus.
• Ability to work flexible schedules, including on-site and off-shift validation activities.