Senior Engineer, Global Process Validation

Senior Engineer, Global Process Validation

Hybrid - Shanbally, Ringaskiddy, Cork

Closing Date: 26th October 2026

Summary Description

The Senior Engineer, Global Process Validation reports to the Senior Manager, Global Process Validation and is responsible for supporting lifecycle process validation and technical assessment activities within a global cGMP environment. This position leads and coordinates projects associated with the implementation of new manufacturing processes, process improvements, technology transfers, and commercial lifecycle management activities across drug substance manufacturing operations.

The role provides technical leadership for process validation and associated technical assessments supporting enzyme replacement therapies and other advanced medicines produced by various process modalities including biologics, conventional small molecules, peptides, and oligonucleotides. Activities may include but are not limited to manufacturing process validation, filtration studies, mixing and hold time evaluations, process characterization studies, shipping qualification, technology transfer, microbial/contamination control evaluations, and risk-based impact assessments. The position supports validation lifecycle activities consistent with FDA, EMA, ICH, and international regulatory expectations.

This individual operates in a highly cross-functional environment and is expected to independently manage technical projects, author and review validation documentation, perform scientific evaluations, communicate recommendations, and support regulatory inspections and submissions.

Responsibilities

• Lead process validation activities for drug substance manufacturing processes from late-stage development through commercial lifecycle management.

• Develop and execute risk based validation strategies consistent with lifecycle process validation principles, including process design, process qualification, and continued process verification.

• Author and review validation master plans, protocols, reports, risk assessments, technical assessments, and supporting regulatory documentation.

• Support implementation of new processes, process changes, manufacturing site transfers, and capacity expansion projects.

• Perform technical evaluations supporting manufacturing process changes, deviations, investigations, CAPAs, and change controls.

• Lead process impact assessments and risk-based evaluations utilizing tools such as FMEA and other quality risk management methodologies.

• Collaborate with Manufacturing, Manufacturing Sciences, Technical Development, Quality, Regulatory Affairs, Engineering, Supply Chain, and external partners to ensure successful project execution.

• Support generation and review of Common Technical Document (CTD) sections and responses to regulatory authority questions.

• Provide technical assessment and oversight for: Extractables and leachables studies, Container closure system evaluations, Material compatibility assessments, Single-use technology evaluations, Shipping and distribution assessments, Facilities/Utilities/Equipment (FUE) Qualification, Cleaning Validation, microbial/contamination control assessments, Process characterization studies, Comparability evaluations.

• Review toxicological risk assessments and scientific justifications supporting material and manufacturing changes.

• Evaluate supplier and contract manufacturing data packages supporting process validation and technical assessments.

• Coordinate activities with contract manufacturing organizations, contract laboratories, and internal manufacturing sites.

• Participate in regulatory inspections, partner audits, and internal audits as a subject matter expert.

• Identify opportunities to improve validation systems, procedures, and business processes.

• Mentor junior engineers and technical staff in validation principles, risk-based decision making, and technical assessment approaches.

• Remain current with evolving industry guidance, emerging technologies, and regulatory expectations.

• Scope

• The Senior Engineer plays a significant role in the approval and implementation of manufacturing processes and technical systems supporting commercial product supply. Decisions and recommendations made by this position may directly impact product quality, regulatory compliance, manufacturing readiness, and supply continuity.

• The position routinely influences project timelines, validation strategies, technical decisions, and regulatory risk assessments that affect global manufacturing operations and external partners.

Education

• Bachelor's degree in Chemical/Biochemical Engineering, Engineering, Biological Sciences, Pharmaceutical Sciences, Chemistry, or related technical discipline required.
• Master's degree or advanced scientific degree is advantageous.
• Formal training in project management or quality risk management is advantageous.

Experience

• 8+ years of experience in a cGMP-regulated biotechnology or pharmaceutical manufacturing environment preferred.

• Demonstrated expertise in manufacturing processes and control strategy with associated experience supporting process validation, technical development, manufacturing, manufacturing sciences, engineering, or related technical functions.

• Experience independently developing risk-based validation approaches as well as authoring and reviewing validation protocols, reports, and supporting technical assessments.

• Experience with biologics, peptides, oligonucleotides, small moleculesor advanced therapy products preferred.

• Working knowledge of FDA, EMA, ICH, Annex 1, and global regulatory expectations governing process validation.

• Strong communication particularly in technical writing, presentation skills, and ability to influence technical decisions.

• Demonstrated ability to lead cross-functional projects and to track and on time delivery of project milestones.

• Experience interacting with regulatory authorities, auditors, or inspection teams is preferred.

• Comfort exploring the use of new tools and technologies such as AI (e.g. Cowork)

• Skills & Competencies

• Process Validation Lifecycle Management

• Quality Risk Management

• Technical Assessment Development

• Microbial and contamination control

• Process Characterization

• Technology Transfer

• Change Control

• Data Analysis and Statistical Evaluation

• Project Management

• Regulatory Compliance

• Technical Writing and Communication

• Cross-functional Leadership

• Supervisor Responsibility

• No direct reports required.

• May provide technical leadership, mentoring, and project oversight for junior engineers, contractors, and cross-functional teams.

• Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

• Equal Opportunity Employer/Veterans/Disabled

• An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status, protected veteran status or any other characteristic protected by law.}