Senior Process Engineer, Biotech Manufacturing

Aphex Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Aphex Group in Ireland seeks a Senior Specialist - Engineering to lead compliant design, construction, qualification and operation of a new state‑of‑the‑art facility during the initial project phase. You will drive the use of the latest technology and automation to create a workplace of the future.

Reporting to the site manufacturing and technology head, you will work with multidisciplinary teams to optimize upstream and downstream processes, support technology transfer, regulatory filings and

Qualifications

• 5–7 years of directly related pharma/biotech experience.
• Strong independent and cross-disciplinary collaboration skills.
• Experience with upstream/downstream processes and tech transfer.
• Knowledge of regulatory filings and GMP practices.
• Excellent oral and written communication abilities.

Responsibilities

• Support design, construction and qualification of upstream & downstream equipment.
• Assist technology transfer and commercialisation activities.
• Support deviation management, change control and batch documentation.
• Collaborate with manufacturing science, quality, analytics and regulatory teams.
• Apply Lean Six Sigma and statistical tools to drive improvements.
• Participate in internal audits and inspections; lead as needed.
• Contribute to safety, quality and customer-focused processes.

Skills

Regulatory knowledge

Statistical methods

DOE design

Multivariate analysis

Lean Six Sigma

Quality & safety compliance

Interdisciplinary collaboration

Communication skills

Independent work

Education

Bachelor's or higher in Biological Sciences / Chemical Engineering / Biological Engineering / Chemistry

PhD without industry experience (considered)

Tools

JMP

Design Expert

SPC

PAT

Job description

Aphex Group in Ireland seeks a Senior Specialist - Engineering to lead compliant design, construction, qualification and operation of a new state‑of‑the‑art facility during the initial project phase. You will drive the use of the latest technology and automation to create a workplace of the future.

Reporting to the site manufacturing and technology head, you will work with multidisciplinary teams to optimize upstream and downstream processes, support technology transfer, regulatory filings and