Senior Development Engineer - Pharma Process & NPI Leader

Merck

Ireland

On-site

EUR 70,000 - 110,000

Full time

4 days ago
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Job summary

Merck Ireland in Ballydine, Co. Tipperary, is seeking a Development Engineer to lead process development, scale-up and technology transfers for solid oral dosage products within the CDS team.

You will drive cross-functional collaboration, ensure cGMP compliance, and deliver robust, validated commercial processes while guiding IPTs and QA. This role emphasizes transfer of processes to production and ongoing process optimization.

Qualifications

  • Post-graduate degree and 6+ years in pharma process development, manufacturing and tech transfer.
  • Strong knowledge of cGMPs, regulatory expectations and Quality Risk Management (QRM).
  • Ability to lead cross-functional project teams and manage complex programs.

Responsibilities

  • Lead design, scale-up, and transfer of new solid oral dosage manufacturing processes.
  • Drive Quality Risk Assessments, investigations, safety assessments, and process improvement initiatives.
  • Author and lead validation programs to ensure compliance with cGMP and cleaning validation requirements.
  • Provide high-level technical support to IPT for multiple manufacturing processes and material evaluation.
  • Manage projects with robust planning to ensure successful product introductions and technology transfers.
  • Identify and implement Lean Six Sigma driven improvements to enhance efficiency.

Skills

Process leadership
Project management
Cross-functional collaboration
Quality risk management
Problem solving

Education

BSc/BEng or higher in Chemical Engineering, Chemistry, Natural Sciences or related
Advanced degree (MSc/PhD) beneficial

Job description

Merck Ireland in Ballydine, Co. Tipperary, is seeking a Development Engineer to lead process development, scale-up and technology transfers for solid oral dosage products within the CDS team.

You will drive cross-functional collaboration, ensure cGMP compliance, and deliver robust, validated commercial processes while guiding IPTs and QA. This role emphasizes transfer of processes to production and ongoing process optimization.

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