Senior Process Development Engineer, Parenteral Drugs

Biopharma Careers; Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amgen seeks a process development specialist to support NPI and tech transfer for parenteral drug products. You will lead process characterization, validation planning and cross-functional investigations across sterile operations. Strong communication and regulatory knowledge are essential.

The role involves collaboration with operations, engineering and external vendors to ensure compliant, high-quality manufacturing and successful technology transfers.

Qualifications

• Problem solving ability and excellent oral and written communications skills.
• Knowledge of cGMPs and other worldwide regulatory requirements.

Responsibilities

• Provides process development support for NPI, technology transfer and lifecycle changes for vial and syringe products.
• Leads risk assessment and CAPA for drug product operations and supports cross-site teams.

Skills

Problem solving

Communication

Regulatory knowledge

Education

Bachelor’s degree in Science/Engineering/Quality

Master’s degree

Associate’s degree

Job description

Amgen seeks a process development specialist to support NPI and tech transfer for parenteral drug products. You will lead process characterization, validation planning and cross-functional investigations across sterile operations. Strong communication and regulatory knowledge are essential.

The role involves collaboration with operations, engineering and external vendors to ensure compliant, high-quality manufacturing and successful technology transfers.