Senior Aseptic Manufacturing Process Specialist

Morgan McKinley; Dún Laoghaire-Rathdown; On-site; EUR 90,000 - 130,000; Full time

Job summary

Morgan McKinley seeks a Senior Specialist Manufacturing with deep aseptic drug product knowledge to own and optimize critical manufacturing processes. You will lead process documentation, drive CAPAs, and steer continuous improvements across the aseptic operations, collaborating with Quality, Validation, Engineering, and Manufacturing teams.

The role emphasizes safe, compliant operations, pro-active problem solving, and delivering reliable performance in a high-paced environment.

Qualifications

• Bachelor’s degree in Science, Engineering or related discipline.
• 5+ years in aseptic Drug Product manufacturing or related cGxP environment.
• Experience with regulatory compliance and cGMP.
• Strong written and verbal communication for cGxP documentation.

Responsibilities

• Act as SME and single point of contact on site and network projects.
• Lead process ownership and drive safety, quality, and compliance.
• Direct initiatives to improve reliability and efficiency of manufacturing processes.
• Lead or support investigations and CAPA implementation to prevent recurrence.
• Identify and lead continuous improvement projects within assigned area.

Skills

Aseptic manufacturing knowledge

cGxP/good documentation

CAPA and investigations

SOP authoring and revision

Cross-functional collaboration

Education

BSc in Science/Engineering

Job description

Morgan McKinley seeks a Senior Specialist Manufacturing with deep aseptic drug product knowledge to own and optimize critical manufacturing processes. You will lead process documentation, drive CAPAs, and steer continuous improvements across the aseptic operations, collaborating with Quality, Validation, Engineering, and Manufacturing teams.

The role emphasizes safe, compliant operations, pro-active problem solving, and delivering reliable performance in a high-paced environment.