Senior Aseptic Manufacturing Process Lead

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

Job summary

Morgan McKinley is seeking a Senior Specialist Manufacturing to lead aseptic Drug Product manufacturing processes, including preparation, formulation, filling, lyophilisation and capping. You will own processes, drive continuous improvement, and champion safety, quality and compliance on site.

You will direct investigations, CAPA implementation, and document governance while collaborating with Manufacturing, Validation, Engineering and Quality teams to achieve operational excellence in a

Qualifications

• Bachelor's degree in Science/Engineering or related discipline with 5+ years in aseptic Drug Product Manufacturing.
• Deep knowledge of cGMP and Eudralex Volume 4 Annex 1.
• Proven ability to lead cross-functional teams and manage documentation.

Responsibilities

• Perform as SME and single point of contact on site and network projects to advance aseptic operations with safety, quality and compliance in mind.
• Accountable for process documentation (SOPs, Training, Electronic Batch Records, Risk Assessments) and gatekeeping of control documents.
• Lead strategic initiatives to develop future processes and continuous improvement projects within assigned area.
• Provide expertise to resolve escalated technical issues and support investigations and CAPAs.
• Monitor process trends and business metrics to drive performance improvements.
• Lead or support investigations impacting safety, quality or compliance and ensure timely CAPAs.
• Stay current on systems and processes and advise on adoption of new techniques.
• Ability to lead change from an aseptic operations perspective is a plus.

Skills

Aseptic manufacturing

cGxP compliance

Process ownership

Documentation control

Regulatory knowledge

Education

Bachelor's in Science/Engineering

Job description

Morgan McKinley is seeking a Senior Specialist Manufacturing to lead aseptic Drug Product manufacturing processes, including preparation, formulation, filling, lyophilisation and capping. You will own processes, drive continuous improvement, and champion safety, quality and compliance on site.

You will direct investigations, CAPA implementation, and document governance while collaborating with Manufacturing, Validation, Engineering and Quality teams to achieve operational excellence in a