Senior Process Development Engineer - Pharma (Hybrid)

MSD; Ballydine; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

MSD Ballydine in Co. Tipperary seeks a Development Engineer to lead the design, scale-up, and transfer of new solid oral dosage manufacturing processes, ensuring robust commercial processes and timely technology transfers.

You will collaborate with IPTs to drive QRA, investigations, and continuous improvement, applying Lean Six Sigma while maintaining strict cGMP and regulatory standards.

Qualifications

• Minimum 6 years post-graduation experience in pharmaceutical process development and technology transfer.
• Strong understanding of process chemistry, formulation technology, and engineering principles for solid oral dosage platforms.
• Expertise in process development, scale-up, technology transfer, and cleaning validation.
• Knowledge of cGMPs, regulatory expectations, and Quality Risk Management (QRM).
• Proven experience with deviation management systems and root-cause analysis.
• Excellent written and verbal communication with ability to present complex data to diverse audiences.
• Demonstrated capability to lead project teams and work across functional boundaries.
• Strong project management, problem-solving and time-management skills.

Responsibilities

• Lead the design, scale-up, and transfer of new solid oral dosage manufacturing processes.
• Lead cross-functional teams to drive QRA, investigations, safety assessments, and process improvements.
• Author, execute, and lead process and cleaning validation programs to meet cGMP and regulatory expectations.
• Provide high-level scientific and technical troubleshooting support to IPT for multiple manufacturing processes.
• Operate as a project leader with robust planning to ensure successful product introductions and tech transfers.
• Pioneer Lean Six Sigma-driven improvements to enhance efficiency and optimization.
• Ensure engineering operations comply with cGMP, Environmental, and Health & Safety standards.

Skills

Process chemistry

Formulation tech

Engineering principles

cGMP & QRM

Deviation management

Root-cause analysis

Project management

Cross-functional leadership

Communication skills

Time management

Education

BSc/BEng in chemical engineering

MSc/PhD beneficial

Job description

MSD Ballydine in Co. Tipperary seeks a Development Engineer to lead the design, scale-up, and transfer of new solid oral dosage manufacturing processes, ensuring robust commercial processes and timely technology transfers.

You will collaborate with IPTs to drive QRA, investigations, and continuous improvement, applying Lean Six Sigma while maintaining strict cGMP and regulatory standards.