Tech Operations

MSD Malaysia

Leinster

On-site

EUR 36,000 - 48,000

Full time

3 days ago
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Job summary

Our Company in Ireland is seeking an Operations Technician at our Dundalk manufacturing facility. You will join a fast‑growing team focused on drug substance manufacturing, quality control, and continuous improvement in a GMP environment.

The role requires 12 months+ in regulated GMP settings, knowledge of cGMP and safety policies, and experience with SOPs, batch records, and production controls. You will work in a high‑tech, single‑use facility and support lean initiatives and cross‑functional

Qualifications

  • 12 months or more in a regulated GMP environment.
  • Knowledge of cGMP, safety and environmental regulations in biopharmaceuticals.
  • Experience recording information in real‑time.
  • Experience executing operations following SOPs, Batch Records and Manufacturing Controls Systems.
  • Experience in the biopharmaceutical industry.
  • Experience in Grade C/D environments.

Responsibilities

  • Manufacture drug substance using inoculation, cell expansion and bioreactor activities.
  • Set up single‑use equipment between runs per GMP and EHS.
  • Perform DS Downstream Processing, Upstream Processing, and Buffer/Media preparation.
  • Lead shift handovers and liaise with Shift Lead on production issues.
  • Maintain a safety‑oriented, cGMP‑compliant work environment.

Skills

Analytical problem solving
Biological manufacturing
Cleanroom gowning
Computer literacy
GMP operations
Good Manufacturing Practices (GMP)
Manufacturing quality control
SOPs
Upstream processing
Vaccine production

Education

Certificate/Diploma/Degree/Trade qualification

Job description

Job Description Ireland – The Company: Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from our Company in Ireland to the world.

Our Commitment to Ireland: Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company's top products, helping save and enhance lives in over 140 countries around the world.

As a cutting-edge, state-of-the‑art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry‑leading network.

An exciting opportunity an Operations Technician has arisen at our Dundalk manufacturing facility, you will be a key member of our fast‑growing, dynamic startup, working with cutting‑edge technology. This role is focused on delivering to the patient through living the Dundalk culture, including a commitment to safety, focusing on right first time in everything we do, and concentrating on the engagement and development of self and peers. Bring energy, knowledge, innovation to carry out the following:

  • Manufacture drug substance through inoculation, cell expansion, and bioreactor activities, leading to filtration and purification of the product in a state‑of‑the‑art single‑use technology‑based facility.
  • Set up single‑use equipment between runs and carry out the production process according to world‑class GMP and EHS principles.
  • Perform manufacturing processes including DS Downstream Processing (DSP), Upstream Processing (USP), and Buffer/Media preparation.
  • Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records.
  • Assist in maintaining a safety‑oriented, cGMP‑compliant work environment at all times.
  • Write, review, and revise area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies, and Work Instructions.
  • Train and mentor colleagues in SOPs, process execution, and equipment operation.
  • Support the Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
  • Assist with the investigation of and operations deviations through the Quality System, engaging with all relevant personnel and functions as appropriate.
  • Lead and actively participate in shift handovers.
  • Liaise with the Shift Lead regarding issues that may arise within the production area, including highlighting operational challenges.
  • Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1, our company Production System (MPS)) to optimize efficiency and drive the culture of Continuous Improvement (CI).
  • Provide assistance and/or support maintenance, engineering, quality, or other colleagues as requested.
  • Conduct all activities in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.
  • Support the development, commissioning & qualification of new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.

What skills you will need: Certificate, Diploma, Degree, Trade qualification, or equivalent demonstrated experience of 12 months or more in a regulated environment, GMP environment.

Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.

Experience with recording information in real‑time using electronic or manual systems.

Experience in executing operations while following SOPs, Batch Records, and Manufacturing Controls Systems.

Experience in the biopharmaceutical industry.

Experience of working in Grade C, D, and CNC environments.

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing talented, and committed people together.

Required Skills:
  • Analytical Problem Solving
  • Biological Manufacturing
  • Cleanroom Gowning
  • Computer Literacy
  • GMP Operations
  • Good Manufacturing Practices (GMP)
  • Manufacturing Quality Control
  • Standard Operating Procedure (SOP)
  • Upstream Processing
  • Vaccine Production
Preferred Skills:
  • Lean Manufacturing
  • Team Training

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): NA

Flexible Work Arrangements: Not Applicable

Job Posting End Date: 09/17/2026

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. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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