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

MSD Malaysia; Dublin; Hybrid; EUR 80,000 - 110,000; Full time

Job summary

Merck & Co., Inc.'s Biotech Dublin site is seeking a Specialist MS&T (process engineering & NPI) to support sustaining activities, process qualification, and technology transfer for upstream or downstream biologics manufacturing. The role emphasizes cGMP compliance, QA collaboration and cross-functional troubleshooting.

The successful candidate will contribute to PPQ batches, CAPAs and continuous improvement initiatives while collaborating with manufacturing science, quality and regulatory teams

Qualifications

• 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 preferred but not essential.

Responsibilities

• Ensure compliance with cGMP in day-to-day activities and all job functions.
• Support development and PPQ batches, change control management and implementation.
• Assist investigations, ensure effective RCA and CAPAs.
• Participate in audits and inspections.
• Support Lean Six Sigma initiatives for site improvements.
• Assist site initiatives to improve compliance and efficiency.
• Support experimental design, data analysis and interpretation.
• Interpret process monitoring trends and support further investigations and changes.

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

Role Overview

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.

We have a great opportunity for a Specialist MS&T to join the team; we welcome candidates with either upstream or downstream process engineering experience. The Specialist MS&T (process engineering & NPI) supports sustaining activities, manages and drives process qualification and validation related activities. Supports the design, construction and qualification of upstream & downstream equipment, NPI/technology transfer and commercialization at our Biotech site.

Key Responsibilities

• 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 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.
• Facilitate problem solving & risk assessment (FMEA) projects/meetings.
• Make 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.

Required Qualifications

• 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

Desired Background

• 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.

Company Culture

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Employer Information

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Employee Status: Regular

Relocation: Yes

VISA Sponsorship: Yes

Travel Requirements:

Flexible Work Arrangements: Hybrid

Hybrid Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 10/13/2026

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.