Process Engineer

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

• Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required.
• Act as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines.
• Review and/or author technical protocols, reports or memos.
• Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
• This includes overseeing data collection and analysis, ensuring ongoing process performance and control, partnering with CMOs to identify and mitigate risks, and driving continuous improvements to strengthen product robustness.
• The role will collaborate closely with Quality, MSAT, and CMO technical teams to ensure compliance with regulatory expectations and maintain a state of control throughout the product lifecycle.
• Support manufacturing tech transfer of new and existing products.
• Support multi-functional teams to formulate plans and strategy that meet defined objectives.
• Troubleshoot manufacturing issues, conduct effective problem-solving and provide solutions leading to product releases.
• Review, execute and support validation activities at third party contractors.
• Work with Regulatory teams as needed to support product submissions to the FDA.

Responsibilities

• Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required.
• Act as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines.
• Review and/or author technical protocols, reports or memos.
• Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
• This includes overseeing data collection and analysis, ensuring ongoing process performance and control, partnering with CMOs to identify and mitigate risks, and driving continuous improvements to strengthen product robustness.
• The role will collaborate closely with Quality, MSAT, and CMO technical teams to ensure compliance with regulatory expectations and maintain a state of control throughout the product lifecycle.
• Support manufacturing tech transfer of new and existing products.
• Support multi-functional teams to formulate plans and strategy that meet defined objectives.
• Troubleshoot manufacturing issues, conduct effective problem-solving and provide solutions leading to product releases.
• Review, execute and support validation activities at third party contractors.
• Work with Regulatory teams as needed to support product submissions to the FDA.

Requirements

• Bachelor of Science, Pharmacy, Engineering, or Chemistry.
• 8 to 10+ years in Pharmaceutical Operations or Technical Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• 10+ years in a Technical Services or engineering function.
• Experience in third party manufacturing, technical services support function and plant operations.
• Good knowledge and hands-on application of Word, Excel, and Powerpoint are necessary.

Skills:

• Thorough knowledge of cGMP's and regulatory requirements with respect to development, engineering and validation of pharma products.
• Comprehensive knowledge of drug product manufacturing for solid and liquid oral dosages. Knowledge of API manufacturing a plus.
• Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
• Knowledge of product manufacture, formulation, quality, FDA and EMA regulations, technical transfer, process development and validation.
• Skilled in improving productivity, cost analysis, and plant equipment evaluation.