Aseptic Process Engineer – Tech Transfer & NPI

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

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.