Spclst, Process Engineering (MS&T) - Upstream or Downstream

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

Job summary

MSD in Dublin seeks a skilled professional to join its Biotech manufacturing science & technology team. You will ensure cGMP compliance, support development and PPQ batches, and assist investigations with root cause analysis and CAPAs.

You'll participate in audits, apply Lean Six Sigma to drive continuous improvement, and collaborate with regulatory, quality, analytics and manufacturing groups to secure product quality and process robustness.

Qualifications

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable.
• Experience with upstream cell culture and/or downstream purification of biological molecules.
• Experience in change management, deviations and CAPAs management (desirable)

Responsibilities

• Ensure cGMP compliance and regulatory requirements in day-to-day activities.
• Support development and PPQ batches, change control management and implementation.
• Assist investigations, root cause analysis and CAPAs.
• Participate in audits and inspections.
• Support Lean Six Sigma and continuous improvement initiatives.
• Lead cross-functional MS&T initiatives and support process improvements.
• Apply Lean Six Sigma tools and lead FMEA projects.

Skills

CAPA Investigations

Cell Cultures

Manufacturing Operations

Process Control

Six Sigma

Technology Transfer

Education

Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or comparable

Job description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno-oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

Bring energy, knowledge, innovation to carry out the following

• Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Support the execution of development and PPQ batches, change control management and implementation.
• Assist in and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs.
• Participate in audits and inspections.
• Support continuous improvement through Lean Six Sigma methodologies.
• Support various site initiatives to improve compliance status and overall operational efficiency of the site.
• Support the experimental design, execution, data analysis and interpretation.
• Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
• Author and review of batch documentation, technical reports and global regulatory submissions.
• Support multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
• Apply Lean Six Sigma tools by
• Securing continuity of an appropriate LSS/CEM level of knowledge.
• Facilitating problem solving & risk assessment (FMEA) projects/meetings.
• Making problems visible and strive for continuous improvement.
• Serve as a key member during internal audits and external inspections/audits.
• Lead and support various MS&T organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

In order to excel in this role, you will more than likely have

• Degree in (Bio) Chemistry, Process Technology, Biotechnology, Engineering or
• comparable.
• Experience with upstream cell culture and/or downstream purification of biological
• molecules.
• Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is preferred but not essential
• Experience in change management, deviations and CAPAs management (desirable)

Required Skills

CAPA Investigations, Cell Cultures, Manufacturing Operations, Process Control, Six Sigma, Technology Transfer

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

10/13/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R418785