Process Engineer – Product & Process Technical Services

Galway
Contract
Full-time

1 month ago

Process Engineer – Product & Process Technical ServicesAbout the opportunityTake on a key role in a leading global pharmaceutical company as a Process Engineer – Product & Process Technical Services, contributing to critical process improvements and new product introductions.This is a 12-month contract opportunity. You will be responsible for supporting process development and optimization, ensuring regulatory compliance, and leading key activities such as technology transfer, alternate source qualification, and new product introductions (NPIs).Key Responsibilities include:Design, develop, and optimize aseptic pharmaceutical manufacturing processes to ensure robustness, scalability, and cost-effectiveness.
Conduct process risk assessments (e.g., FMEA) and define risk-mitigation strategies.
Lead investigations into deviations, non-conformances, and root cause analyses.
Support scale-up, technology transfer, ASQ, and commercialization of new products through study design, protocol generation, and reporting of outcomes.
Prepare and execute Process Validation (PV) protocols, including PPQ and Continued Process Verification (CPV).
Provide on-the-floor technical support for routine manufacturing operations and deviations.
Support technology transfers between development, pilot, and commercial manufacturing sites.
Collaborate with R&D and Site Operations teams to ensure smooth transitions and successful NPIs.
Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and scale-up.
Perform other duties as necessaryRequirements:Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related discipline.
3–7 years of experience in pharmaceutical manufacturing, process engineering, or technical services and a minimum of 2 years of experience in sterile injectables or biologics manufacturing.
Practical knowledge of filling lines, isolators, autoclaves, dehydrogenation tunnels, and lyophilizers.
Strong understanding of aseptic processing, terminal sterilization, and lyophilization.
Experience with process validation (PPQ/CPV), DOE, and statistical process control (SPC).
Working knowledge of cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile manufacturing.
Familiarity with aseptic behaviours, filter integrity testing, and single-use systems.
Proficiency in cGMP documentation (protocols, reports, change controls).
Experience using data analysis tools (e.g., Minitab) and process modelling software.
Strong analytical, problem-solving, and communication skills.Preferred:Lean or Six Sigma certification.
Knowledge of Process Analytical Technology (PAT).
Experience with automation systems (SCADA, MES).

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