Process Engineer, MS&T

Location: Middletown, DE, US

Employment Type: OTHER

Overview

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

Responsibilities

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 related to manufacturing processes, materials, equipment, and facilities.
• Evaluate potential impacts to validation status, regulatory filings, and product quality.
• Support regulatory submissions and responses as required.
• Participate in customer audits, agency inspections, and technical due diligence activities.
• Ensure compliance with applicable cGMP, FDA, EMA, and ICH requirements.

Future Sterile Manufacturing Support

As site capabilities evolve, this role may support:

• Sterile product technology transfers.
• Aseptic manufacturing process introductions.
• Sterile process validation activities.
• Facility startup, qualification, and operational readiness activities.
• Contamination Control Strategy (CCS) implementation.
• Process lifecycle management for sterile products.
• Cross-functional initiatives supporting sterility assurance and aseptic manufacturing operations.

Qualifications

Education

• Bachelors degree in Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific discipline required.
• Advanced degree preferred.

Experience

• Bachelors degree with 8+ years of pharmaceutical manufacturing experience, or
• Masters degree with 6+ years of pharmaceutical manufacturing experience.
• Demonstrated experience leading complex technical projects in a GMP environment.

Required Experience

Experience in several of the following areas:

• Oral Solid Dosage (OSD) manufacturing
• Technology Transfer
• New Product Introduction (NPI)
• Process Validation
• Process Performance Qualification (PPQ)
• Continued Process Verification (CPV)
• Commercial Manufacturing Support
• Investigation and Root Cause Analysis
• Direct Compression
• Dry Granulation
• Roller Compaction
• Wet Granulation
• Compression
• Capsule Filling
• Film Coating
• Packaging Operations

Preferred Experience

CDMO Experience

• Customer-facing technical support.
• Commercial product launches.
• Multi-product manufacturing environments.
• Technology transfers across sites or organizations.

Sterile Manufacturing Experience (Preferred but Not Required)

Experience in any of the following is considered advantageous:

• Aseptic Processing
• Sterile Drug Product Manufacturing
• Sterile Filling Operations
• Lyophilization
• Terminal Sterilization
• Isolator or RABS Technology
• Sterility Assurance Programs
• Media Fills (APS)
• Environmental Monitoring
• Contamination Control Strategy (CCS)
• Sterile Process Validation
• Annex 1 Compliance

Strong OSD candidates without sterile experience are encouraged to apply.

 

Knowledge, Skills, and Competencies

• Strong understanding of cGMP principles and pharmaceutical manufacturing regulations.
• Knowledge of FDA, EMA, and ICH requirements, including ICH Q8, Q9, and Q10.
• Understanding of lifecycle process validation principles.
• Experience applying risk management methodologies and scientific decision-making.
• Strong troubleshooting and root cause investigation skills.
• Ability to analyze manufacturing data and apply statistical tools to support process decisions.
• Excellent technical writing and communication skills.
• Strong project leadership and organizational abilities.
• Ability to lead cross-functional teams and influence stakeholders without direct authority.
• Effective communication and presentation skills.

Success Measures

Success in this role will be measured by:

• Successful execution of technology transfer projects.
• On-time completion of new product introduction milestones.
• Successful process and cleaning validation, and PPQ execution.
• Process performance and CPV metrics.
• Reduction of process deviations and manufacturing disruptions.
• Timely closure of investigations and CAPAs.
• Improvement of process robustness, yield, and efficiency.
• Customer satisfaction and project delivery performance.
• Inspection and audit readiness.

Ideal Candidate

The ideal candidate is a technically strong pharmaceutical manufacturing professional with demonstrated expertise in technology transfer, new product introduction, process and cleaning validation, and commercial manufacturing support. They thrive in a fast-paced, customer-focused environment, can successfully lead cross-functional teams, and are capable of supporting both current OSD operations and the future expansion of sterile manufacturing capabilities at the site.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.