Product Process Engineer

Role Summary:

• A new vacancy has arisen for a Product Process Engineer to join our client’s manufacturing facility in Co. Galway.
• As part of the Technical Services function the Technical Services Engineer – Product/Process will be responsible for supporting the development & optimization of aseptic pharmaceutical manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives as well as Technical Transfer, Alternate Source Qualification and New Product Introductions.
• 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.

Core Duties and Responsibilities:

Process Development & Optimization:

• Design, develop, and optimize pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
• Conduct and document process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
• Lead investigations into deviations, non-conformances, and root cause analyses.
• Support scale-up, tech transfer, ASQ and commercialization of new products in respect of study design, protocol generation and reporting of outcomes.

Validation & Compliance:

• Preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
• Generation of change controls aligned with site procedures to support product/process changes
• Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
• Support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.

Manufacturing Support & Troubleshooting:

• Provide on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
• Collaborate with production and quality teams to ensure consistent process performance.
• Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).

NPI, Technical Transfer & Scale-Up:

• Support technology transfers between development, pilot, and commercial-scale manufacturing.
• Work closely with R&D and Site Operations teams to ensure smooth process transitions.
• Define critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up.

Continuous Improvement & Innovation:

• 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.

Perform other duties as assigned

Periodic travel is required

Minimum Qualifications and Experience:

Essential Requirements:

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
• 3–7 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
• At least two years 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 modeling software.
• Strong analytical and problem-solving skills, with ability to draw inferences and follow prescribed and detailed procedures to solve complex problems.
• Excellent communication and cross-functional collaboration abilities.
• Ability to manage multiple projects in a fast-paced environment.
• Good language skills, with ability to read/analyse/write/interpret detailed technical reports & correspondence
• Good interpersonal, presentation and communication skills

Preferred Qualifications:

• Six Sigma or Lean Manufacturing certification.
• Experience with automation systems (e.g., SCADA, MES).
• Knowledge of process analytical technology (PAT).

Please note, we do not require agency assistance with this role.