Senior Bioprocess Operations Specialist (24/7 Shift)

MSD Malaysia

Dunboyne

On-site

EUR 70,000 - 95,000

Full time

5 days ago
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Job summary

Merck & Co., Inc. in Dunboyne is seeking a Senior Manufacturing Bioprocess Associate to provide operational support for shop floor operations in the Late Stage and Launch Pipeline at a new state-of-the-art single-use biotechnology facility.

The role is site-based with a 24/7 shift schedule and requires expertise across Fed Batch and Continuous Manufacturing workflows. Responsibilities include operating according to batch records and SOPs, enabling end-to-end production, and contributing to the

Qualifications

  • Level 7 qualification in a science or engineering discipline desired.
  • Level 6 with a minimum of 2+ years’ GMP Manufacturing experience or equivalent.
  • Competent in troubleshooting and practical problem-solving.
  • Ability to work independently and within a cross-functional team.
  • Familiarity with contamination control and batch release requirements.
  • Understanding of Upstream or Downstream Unit Operations for mAb manufacturing.
  • Understanding of both continuous and batch fed manufacturing processes.
  • Experience with Emerson DeltaV, PAS-X, and the use of Automation in manufacturing processes.
  • Experience with various Single-Use techniques in end-to-end Single Use facilities.
  • Commissioning and Qualification experience.

Responsibilities

  • Support end-to-end production operations for Fed Batch and Continuous Manufacturing.
  • Operate equipment according to batch records, sampling plans, and SOPs.
  • Show initiative to solve problems and continuously improve processes.
  • Maintain safety and compliance culture on site.
  • Assist in authoring electronic batch records, sampling plans, work instructions, and SOPs.

Skills

Troubleshooting
Cross-functional teamwork
Contamination control
Unit Operations understanding
Continuous & batch manufacturing
Upstream Operations
Downstream Operations
Automation in manufacturing

Education

Bachelor-level qualification in science or engineering
Level 6 GMP experience (2+ years)

Tools

DeltaV DCS
PAS-X
SAP Systems
Single Use Technology

Job description

Merck & Co., Inc. in Dunboyne is seeking a Senior Manufacturing Bioprocess Associate to provide operational support for shop floor operations in the Late Stage and Launch Pipeline at a new state-of-the-art single-use biotechnology facility.

The role is site-based with a 24/7 shift schedule and requires expertise across Fed Batch and Continuous Manufacturing workflows. Responsibilities include operating according to batch records and SOPs, enabling end-to-end production, and contributing to the

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