Biotech Process Engineering Lead - Hybrid & Tech Transfer

PSC Biotech® Corporation; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

PSC Biotech seeks a Senior Specialist - Engineering to lead design, qualification and transfer of biologics processes at our facility in Ireland. The role emphasizes GMP compliance, analytics, and cross‑functional collaboration with quality, regulatory and manufacturing teams.

The ideal candidate has 5+ years (MSc) or 7+ years (BSc) in pharma/biotech, strong communication skills, and experience with Lean Six Sigma. Hybrid onsite work is expected with a January 4, 2027 start date.

Qualifications

• Minimum 5 years (MSc) or 7 years (BSc) directly related experience in academia, pharma or biotech.
• Working knowledge of regulatory requirements and current GMP.
• Ability to work independently and in multidisciplinary teams.

Responsibilities

• Support design, construction and qualification of upstream and downstream equipment.
• Assist technology transfer and commercialization of processes.
• Analyze data and interpret trends for process improvements.
• Support deviation management and change control prioritization.
• Author and review batch documentation and regulatory submissions.
• Lead Lean Six Sigma and risk assessment initiatives (FMEA).
• Contribute to audits and inspections and site readiness activities.

Skills

Self-starter

Multidisciplinary teamwork

Regulatory understanding

Communication skills

Process engineering knowledge

Education

Bachelor’s degree in Biological Sciences / Chemical Engineering / Biological Engineering / Chemistry

PhD (without industry experience)

Tools

JMP

Design Expert

Statistical process control (SPC) tools

Job description

PSC Biotech seeks a Senior Specialist - Engineering to lead design, qualification and transfer of biologics processes at our facility in Ireland. The role emphasizes GMP compliance, analytics, and cross‑functional collaboration with quality, regulatory and manufacturing teams.

The ideal candidate has 5+ years (MSc) or 7+ years (BSc) in pharma/biotech, strong communication skills, and experience with Lean Six Sigma. Hybrid onsite work is expected with a January 4, 2027 start date.