Process Engineer – Product & Process

Asset Recruitment; Connacht; On-site; EUR 65,000 - 90,000; Full time

Job summary

Asset Recruitment is seeking a Process Engineer – Product & Process for a 6-month contract at a Galway site. The role focuses on developing and optimizing aseptic manufacturing processes, ensuring regulatory compliance, and leading technology transfer and NPIs.

You will work with Production, Quality, Regulatory, and Engineering to drive process improvements, scale-up, and PICCP-CPP/CQ A monitoring for robust transfer and scale-up.

Qualifications

• 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.

Responsibilities

• 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, and commercialization of new products through study design and reporting.
• Prepare and execute PV protocols, including PPQ and CPV.
• Generate and manage change controls for product or process changes.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Support regulatory submissions 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 reduce variability in CQAs.
• Support technology transfers between development, pilot, and commercial sites.
• Collaborate with R&D and Site Operations for NPIs.
• Define and monitor CPPs and CQAs for robust transfer and scale-up.
• Identify and implement Lean/Six Sigma improvements.
• Evaluate new technologies to enhance efficiency and yield.
• Support cost-reduction initiatives while maintaining quality and compliance standards.

Skills

Aseptic processing

Process validation (PPQ)

DOE

Statistical process control (SPC)

cGMP

FMEA

Scale-up

Technology transfer

Data analysis (Minitab)

Documentation proficiency

Education

Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related discipline

Tools

Filling machines

Isolators

Autoclaves

Depyrogenation tunnels

Lyophilizers

Analytical software (e.g., Minitab)

Job description

Ref. 1396

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.

Validation & Compliance

• 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.

Manufacturing Support & Troubleshooting

• 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).

Technology Transfer, NPI & Scale-Up

• 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.

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 standards.
• Perform other duties as necessary

Requirements:

• 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.

Technical Skills

• 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.

Soft Skills

• Strong analytical and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.
• Ability to manage multiple projects in a fast-paced environment.

Preferred:

• Lean or Six Sigma certification.
• Knowledge of Process Analytical Technology (PAT).
• Experience with automation systems (SCADA, MES).