Biotech Process Engineering Specialist - Hybrid, Visa

MSD; Swords; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Visa sponsorship

Hybrid work model

Career growth opportunities

Job summary

MSD in Ireland's Dublin Biotech site is seeking a Specialist MST (process engineering) to support upstream or downstream bioprocess activities, including qualification, validation, and technology transfer as part of NPI initiatives. The role will be placed based on relevant experience and aims to ensure cGMP compliance and robust manufacturing.

The candidate will work closely with QA, regulatory, analytics and manufacturing teams to drive CAPA programs, process optimization and continuous

Qualifications

• Degree in (Bio) Chemistry or related engineering field; experience in upstream or downstream bioprocess is preferred.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing is preferred but not essential.
• Experience in change management, deviations and CAPAs management is desirable.

Responsibilities

• Support process qualification, validation and PPQ batches; document and report results.
• Assist investigations and CAPA activities; support audits/inspections.
• Contribute to Lean Six Sigma-based process improvements and site initiatives.
• Collaborate with manufacturing science, quality, analytics and regulatory for end-to-end product focus.

Skills

CAPA Investigations

Cell Cultures

Manufacturing Operations

Process Control

Six Sigma

Technology Transfer

Education

Bachelor's degree in Biochemistry/ Chemistry / Biotechnology / Engineering

Job description

MSD in Ireland's Dublin Biotech site is seeking a Specialist MST (process engineering) to support upstream or downstream bioprocess activities, including qualification, validation, and technology transfer as part of NPI initiatives. The role will be placed based on relevant experience and aims to ensure cGMP compliance and robust manufacturing.

The candidate will work closely with QA, regulatory, analytics and manufacturing teams to drive CAPA programs, process optimization and continuous