Senior Biopharma Process Engineer - Up/Downstream Excellence

Morgan McKinley; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Unknown Company in Dublin seeks a Senior Specialist, Process Engineering to lead design, qualification, and tech transfer of upstream and downstream manufacturing processes within a state-of-the-art biologics facility. You will partner with MS&T, drive investigations, boost yield, and ensure regulatory readiness across global submissions.

The role requires advanced degrees in chemical/biochemical fields, 5–7+ years of biopharma experience, and expertise in cGMP, DOE, MVDA, and PAT, with a

Qualifications

• Education in chemical/biochemical/biotech fields with advanced degrees.
• Experience in biopharmaceutical manufacturing and process engineering.

Responsibilities

• Drive design, qualification, and commissioning of upstream and downstream equipment through tech transfer to commercial readiness.
• Oversee proactive process monitoring, identify trend shifts, lead deviation investigations, and execute data-driven change controls to optimize yield and robustness.
• Direct DOE, laboratory-scale studies, data modeling, and statistical analysis to troubleshoot operations and streamline manufacturing.
• Author and review master batch records, technical reports, FMEA risk assessments, and CTD sections for global regulatory submissions.
• Utilize Lean Six Sigma tools to drive root-cause analysis, reduce process variability, and lead MS&T initiatives.
• Act as a key SME during internal audits and regulatory inspections (FDA, HPRA/EMA).

Skills

Leadership

Statistics

DOE

MVDA

PAT

Regulatory filings

Tech transfer

Education

Bachelor’s/Master’s/PhD in Chemical/Biochemical/ Biotechnology/ Biological Sciences/ Chemistry

Tools

JMP

Design-Expert

Job description

Unknown Company in Dublin seeks a Senior Specialist, Process Engineering to lead design, qualification, and tech transfer of upstream and downstream manufacturing processes within a state-of-the-art biologics facility. You will partner with MS&T, drive investigations, boost yield, and ensure regulatory readiness across global submissions.

The role requires advanced degrees in chemical/biochemical fields, 5–7+ years of biopharma experience, and expertise in cGMP, DOE, MVDA, and PAT, with a