Senior Bioprocess Engineer – Tech Transfer & Optimization

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

Job summary

Morgan McKinley is seeking a Senior Specialist, Process Engineering for its Dublin biopharmaceutical facility. You will champion upstream and downstream manufacturing design, qualification, and tech transfer to commercial readiness, while leading cross‑functional teams to improve yield and robustness.

You will also author regulatory submissions, manage analytics, and support audits in a high‑performing environment, leveraging Lean Six Sigma and PAT tools to drive continuous improvement.

Qualifications

• 7+ years in biopharmaceutical/biotechnology process engineering or related field.
• Experience with cGMP and global regulatory requirements.
• Strong DOE, MVDA, PAT and statistical analysis skills.
• Experience leading cross-functional teams and driving technical decisions.
• Ability to author regulatory filings and CTD sections.

Responsibilities

• Drive design, qualification, and commissioning of upstream and downstream equipment through tech transfer to commercial readiness.
• Oversee process monitoring, deviation investigations, and change controls to optimize yield and robustness.
• Direct DOE studies, laboratory-scale experiments, data modeling, and statistics to troubleshoot operations.
• Author and review master batch records, technical/campaign reports, and CTD sections for regulatory submissions.
• Lead continuous improvement using Lean Six Sigma tools and mentor MS&T teams.
• Act as SME during audits and regulatory inspections (FDA, HPRA/EMA).

Skills

Process engineering

cGMP

Regulatory submissions

DOE

MVDA

Statistical analysis

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Chemical/Biochemical/Biology related field

Master's degree

PhD in process science or related field

Tools

JMP

Design-Expert

Process Analytical Technology (PAT)

MVDA software

Job description

Morgan McKinley is seeking a Senior Specialist, Process Engineering for its Dublin biopharmaceutical facility. You will champion upstream and downstream manufacturing design, qualification, and tech transfer to commercial readiness, while leading cross‑functional teams to improve yield and robustness.

You will also author regulatory submissions, manage analytics, and support audits in a high‑performing environment, leveraging Lean Six Sigma and PAT tools to drive continuous improvement.