Process Engineer, MS&T

The Process Engineer is a key member of the Manufacturing Science & Technology (MS&T) organization responsible for leading new product introductions (NPI), technology transfers, process validation activities, commercial manufacturing support, and lifecycle management of pharmaceutical manufacturing processes.

This position will initially support Oral Solid Dosage (OSD) operations and play a critical role in onboarding new products, executing technology transfers, leading process and cleaning validation, and ensuring successful commercialization of customer products. The role serves as the technical process owner for assigned products and provides scientific and engineering leadership throughout the product lifecycle.

Working cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, Regulatory Affairs, and customers, the Process Engineer ensures manufacturing processes are robust, compliant, scalable, and capable of consistently delivering high-quality products.

As the site's manufacturing capabilities expand, the position may also support sterile drug product manufacturing, technology transfer, validation, and lifecycle management activities.

Technology Transfer & New Product Introduction

• Lead internal and external technology transfer activities for new and existing products.
• Serve as the technical lead for new product introductions into the site.
• Review product development histories, process characterization studies, validation reports, control strategies, and commercial manufacturing data.
• Perform process fit-gap assessments between sending and receiving sites.
• Evaluate process scalability, equipment compatibility, and manufacturing readiness.
• Develop and execute science- and risk-based transfer strategies.
• Lead cross-functional teams responsible for successful product transfer and commercialization.
• Support engineering batches, demonstration batches, registration batches, PPQ campaigns, and commercial launches.
• Facilitate process knowledge transfer from development organizations, clients, and manufacturing sites into commercial operations.
• Identify and mitigate technical risks throughout transfer and launch activities.
• Serve as the primary technical interface for products at the Middletown site.

Typical Deliverables

• Technology Transfer Protocols and Reports
• Product Introduction Plans
• Manufacturing Readiness Assessments
• Equipment Equivalency Assessments
• Process Comparability Evaluations
• Scale-Up and Scale-Down Assessments
• Process and Cleaning Validation Protocols and Reports
• Technical Risk Assessments
• Process Control Strategies

Process Validation

• Develop validation strategies using science- and risk-based principles.
• Author, review, and execute:
• Process Performance Qualification (PPQ) Protocols and Reports
• Validation Plans
• Continued Process Verification (CPV) Plans
• Validation Summary Reports
• Risk Assessments
• Provide technical oversight during execution of validation campaigns.
• Analyze process data and ensure manufacturing processes are robust, reliable, and maintain a validated state.
• Collaborate with Quality and Manufacturing organizations to resolve validation-related issues.
• Support implementation of lifecycle process validation practices.

Process Ownership & Lifecycle Management

• Serve as the process subject matter expert (SME) for assigned commercial products.
• Provide technical support throughout the product lifecycle.
• Monitor process performance and evaluate process capability trends.
  
  Lead Continued Process Verification (CPV) programs.
• Participate in Annual Product Quality Reviews (APQRs).
• Lead process improvements focused on robustness, yield, efficiency, and product quality.
• Ensure manufacturing processes remain compliant and in a state of control.
• Identify and implement opportunities for continuous improvement through process understanding and data analysis.

Manufacturing Support & Troubleshooting

• Provide direct technical support to manufacturing operations.
• Support commercial production campaigns and critical manufacturing activities.
• Investigate process deviations and manufacturing events.
• Perform root cause analysis and develop and implement corrective and preventive actions (CAPAs).
• Troubleshoot processing challenges associated with:
• Dispensing
• Blending
• Dry Granulation
• Roller Compaction
• Wet Granulation
• Milling
• Compression
• Encapsulation
• Film Coating
• Packaging Operations
• Assess process impacts associated with investigations and manufacturing changes.

Change Management & Regulatory Support

• Author and review change controls…