Process Engineer - Product & Process
Posted 8 hours 17 minutes ago by Asset Recruitment
Permanent
Full Time
Other
Connacht, Ireland
Job Description
Process Engineer - Product & Process 
Our client is a leading global pharmaceutical company, and they are seeking a Process Engineer - Product & Process to join their team at their site in county Galway on a 6-month contract role. As part of the Technical Services Function, the successful candidate 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). This role involves collaboration with cross functional teams, including Production, Quality, Regulatory and Engineering, to enhance efficiency, scale up processes, perform NPIs and troubleshoot manufacturing challenges.
Key Responsibilities Process Development & Optimization- 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).
- Generate and manage change controls in line with site procedures for product or process changes.
- Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
- Support regulatory submissions (e.g., CMC documentation) with technical data and justifications.
- Provide on the floor technical support for routine manufacturing operations and deviations.
- Partner with production and quality teams to maintain consistent process performance.
- Analyse process data trends to identify improvement opportunities and reduce variability in critical quality attributes (CQAs).
- 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.
- Identify and implement process improvements using Lean, Six Sigma, and other problem solving methodologies.
- Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
- Support cost reduction initiatives while maintaining quality and compliance standards.
- Perform other duties as necessary.
- 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.
- Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
- Experience with process validation (PPQ), DOE, and statistical process control (SPC).
- Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
- Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
- Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, and lyophilizers, modes of operation, critical process parameters etc.
- Good knowledge of aseptic behaviours, filter integrity testing, single use systems etc.
- Proficiency in data analysis tools (e.g., Minitab) and process modelling software.
- Strong analytical and problem solving skills.
- Excellent communication and cross functional collaboration abilities.
- Ability to manage multiple projects in a fast paced environment.
- Lean or Six Sigma certification.
- Knowledge of Process Analytical Technology (PAT).
- Experience with automation systems (SCADA, MES).