Process Engineer, MS&T

WuXi AppTec•Middletown, DE

About The Position

The Process Engineer is a key member of the Manufacturing Science & Technology (MS&T) organization, leading new product introductions, technology transfers, process validation, commercial manufacturing support, and lifecycle management of pharmaceutical manufacturing processes. Initially, the role supports Oral Solid Dosage (OSD) operations and serves as the technical process owner for assigned products, providing scientific and engineering leadership throughout the product lifecycle. The position works cross-functionally with Manufacturing, Quality, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure processes are robust, compliant, scalable, and capable of consistently delivering high-quality products. As site capabilities expand, the role may also support sterile drug product manufacturing, technology transfer, validation, and lifecycle management. The Process Engineer leads internal and external transfers and product introductions; reviews development, characterization, validation, control strategy, and commercial manufacturing information; assesses process fit, scalability, equipment compatibility, and readiness; and develops science- and risk-based transfer strategies. The position supports engineering, demonstration, registration, PPQ, and commercial launch activities, facilitates transfer of process knowledge, and identifies and mitigates technical risks. The role develops validation strategies and authors, reviews, and executes validation plans, PPQ protocols and reports, Continued Process Verification plans, validation summaries, and risk assessments. It provides technical oversight during validation campaigns, analyzes process data, supports issue resolution, and helps maintain processes in a validated state. As process SME for assigned commercial products, the engineer monitors performance and capability trends, leads CPV programs, participates in APQRs, and drives improvements in robustness, yield, efficiency, and quality. The Process Engineer provides direct manufacturing support, investigates deviations and manufacturing events, conducts root cause analysis, develops and implements CAPAs, and assesses process impacts from investigations and changes. The position authors and reviews change controls; evaluates impacts to validation status, regulatory filings, and product quality; supports regulatory submissions and responses; and participates in customer audits, agency inspections, and technical due diligence. It ensures compliance with applicable cGMP, FDA, EMA, and ICH requirements. Future responsibilities may include sterile product transfers and introductions, aseptic process validation, facility startup and readiness, Contamination Control Strategy implementation, and sterility assurance initiatives.

Requirements

Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline.
At least 8 years of pharmaceutical manufacturing experience with a bachelor's degree, or at least 6 years with a master's degree.
Demonstrated experience leading complex technical projects in a GMP environment.
Experience in several relevant areas, including OSD manufacturing, technology transfer, NPI, process validation, PPQ, CPV, commercial manufacturing support, investigation and root cause analysis, or listed OSD processing and packaging operations.
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, communication, and presentation skills.
Strong project leadership and organizational abilities.
Ability to lead cross-functional teams and influence stakeholders without direct authority.

Nice To Haves

Advanced degree.
CDMO experience.
Customer-facing technical support experience.
Commercial product launch experience.
Experience in multi-product manufacturing environments.
Technology transfers across sites or organizations.
Sterile manufacturing experience, including aseptic processing, sterile drug product manufacturing, sterile filling, lyophilization, terminal sterilization, isolator or RABS technology, sterility assurance, media fills (APS), environmental monitoring, CCS, sterile process validation, or Annex 1 compliance.

Responsibilities

Lead internal and external technology transfer activities for new and existing products.
Serve as technical lead for new product introductions and primary technical interface for assigned products at the Middletown site.
Review product development histories, process characterization studies, validation reports, control strategies, and commercial manufacturing data.
Perform process fit-gap, scalability, equipment compatibility, manufacturing readiness, comparability, and scale-up or scale-down assessments.
Develop and execute science- and risk-based transfer strategies and lead cross-functional transfer and commercialization teams.
Support engineering, demonstration, registration, PPQ, and commercial launch batches and campaigns.
Facilitate process knowledge transfer from development organizations, clients, and manufacturing sites into commercial operations.
Identify and mitigate technical risks throughout transfer and launch activities.
Develop validation strategies and author, review, and execute PPQ protocols and reports, validation plans, CPV plans, validation summary reports, and risk assessments.
Provide technical oversight during validation campaigns; analyze process data; and support resolution of validation issues and maintenance of validated state.
Serve as process SME for assigned commercial products and provide technical support throughout their lifecycle.
Monitor process performance and capability trends, lead CPV programs, and participate in APQRs.
Lead process improvements to improve robustness, yield, efficiency, and product quality, and maintain compliant processes in a state of control.
Provide direct technical support to manufacturing operations and commercial production campaigns.
Investigate process deviations and manufacturing events, perform root cause analysis, and develop and implement CAPAs.
Troubleshoot OSD processes including dispensing, blending, dry granulation, roller compaction, wet granulation, milling, compression, encapsulation, film coating, and packaging.
Assess process impacts associated with investigations and manufacturing changes.
Author and review change controls related to manufacturing processes, materials, equipment, and facilities; evaluate impacts to validation status, regulatory filings, and product quality.
Support regulatory submissions and responses, and participate in customer audits, agency inspections, and technical due diligence.
Ensure compliance with applicable cGMP, FDA, EMA, and ICH requirements.
As site capabilities evolve, support sterile product technology transfers, aseptic process introductions and validation, facility startup and readiness, CCS implementation, sterile product lifecycle management, and sterility assurance initiatives.