Senior Process Engineer, Pharma Ops & CPV Lead

Katalyst CRO; Morristown (NJ); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO in Morristown, NJ is seeking an experienced Senior Technical Operations professional to provide technical support for products manufactured at third-party CMOs and to lead CPV activities across CMOs. You will ensure GMP compliance and collaborate with Quality, MSAT, and regulatory teams to maintain product robustness.

The role emphasizes cross-functional teamwork, process validation, tech transfers, and investigations to drive product releases while aligning with FDA submissions and

Qualifications

• 8–10+ years in Pharmaceutical Operations or Technical Operations with cGMP.
• 10+ years in a Technical Services or engineering function.
• Experience in third party manufacturing, technical services support and plant operations.
• Strong Word, Excel and PowerPoint skills.

Responsibilities

• Provide technical support for products manufactured externally at third party contract manufacturers, North American locations.
• Act as technical expert on formulations, scale-up, process validation and equipment qualification.
• Review and/or author technical protocols, reports or memos.
• Lead Continued Process Verification (CPV) activities across CMOs.
• Collaborate with Quality, MSAT and CMO teams to ensure regulatory compliance and control.
• Support manufacturing tech transfer of new and existing products.
• Troubleshoot manufacturing issues and drive solutions leading to product releases.
• Review, execute and support validation activities at third party contractors.
• Work with Regulatory teams to support FDA submissions.

Skills

cGMP knowledge

FDA/EMA regs

Cross-functional

Problem solving

Data analysis

Technical transfer

Documentation

Education

B.S. in Pharmacy, Engineering or Chemistry

Tools

Word

Excel

PowerPoint

Job description

Katalyst CRO in Morristown, NJ is seeking an experienced Senior Technical Operations professional to provide technical support for products manufactured at third-party CMOs and to lead CPV activities across CMOs. You will ensure GMP compliance and collaborate with Quality, MSAT, and regulatory teams to maintain product robustness.

The role emphasizes cross-functional teamwork, process validation, tech transfers, and investigations to drive product releases while aligning with FDA submissions and