Spclst, Operations, Tech Supply

MSD Malaysia; Dunboyne; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work arrangements

Travel 10%

Job summary

MSD Malaysia is seeking a Spclst, Operations, Tech Supply to act as SME for microbiological/virological methods across transfers. You will support method verification, qualification, and regulatory filings while training network teams.

The role requires 4–5 years in Pharmaceutical Microbiology/Virology, project management skills, and ability to work in multidisciplinary teams. Hybrid work arrangement and global collaboration are expected.

Qualifications

• Bachelor’s Degree (Level 8) in a relevant field; Masters desirable or equivalent.
• 4–5 years of experience in Pharmaceutical Microbiology/Virology.
• Strong project management skills and knowledge of GMP.
• Ability to work in multidisciplinary teams and communicate clearly.
• Analytical and technical skills with a focus on support and initiative.

Responsibilities

• Act as SME for microbiological/virological methods across transfers and network.
• Support method verification/suitability studies and regulatory filings.
• Provide training and expert scientific support for Rapid Microbiology methods.
• Lead or participate in root cause analyses and change control activities.
• Ensure GMP compliance in protocols, data, and reports; uphold lab safety.

Skills

Data Analytics

Driving Continuous Improvement

Manufacturing Quality Control

Method Validation

Method Verification

Process Optimization

Technical Transfer

Education

Bachelor’s Degree (Level 8)

Masters degree desirable or equivalent

Job description

Job Description A fantastic opportunity has arisen for a Spclst, Operations, Tech Supply. The individual is a Subject Matter Expert (SME) role for one or more microbiological/virological methods. As an SME, the individual will have an important role in supporting the method verification/method suitability of microbiological/virological methods for one or more commercialized products and provide training to the network. Their responsibilities encompass ensuring the proper introduction and qualification of microbiological/virological methods by the receiving unit (including Dunboyne site) during the transfer process in accordance with applicable guidelines. On an as-needed basis, the Specialist provides practical and scientific support for alternative microbiological technology (Rapid Microbiology Methods), microbiological studies and investigations supporting the Dunboyne site and/or network sites. This means that the SME offers both technical expertise during these processes and travels as required for at least 20% of their time. Bring energy, knowledge, innovation to carry out the following: Microbiological / Virological SME of at least two method / technique, with a scientific understanding of the microbial /virological techniques used in pharmaceutical industry. Responsible for best scientific practices within the lab space and supports from a microbiological perspective, troubleshooting, network and life cycle management activities in the Dunboyne site as well as for the network. Supports the implementation of microbiological methods (compendial/alternative microbiological methods) in a harmonized way to secure efficient implementation at the receiving unit (internally and/or externally). Provides scientific and practical support to analytical investigation during method suitability and routine use. Provides practical support for microbiological tests on an as-needed basis for methods and studies in their expertise for the transfer and commercialization of Biologicals/Vaccines. Participates as a SME in the evaluation, method development, method validation of alternative microbiological technology (Rapid Microbiology Methods). Responsible for authoring primary and secondary source documents used for regulatory filings. Project Member and/or lead. Support the implementation of microbiological methods at receiving units. Supports as SME the Dunboyne QC-Micro and AS&T team. Participates in Root Cause Analysis as SME for significant investigations. Participates as SME in multidisciplinary teams solving technical problems at global or multisite level. Participates in global change control processes as an SME or as change owner. Takes GMP requirements into account when setting up experiments and protocols. Ensures compliance of protocols, lab data and reports. Ensures safety at personnel and at lab level.

What skills you will need: In order to excel in this role, you will more than likely have: Bachelor’s Level 8 Degree, Masters is desirable or equivalent through experience. Minimum of 4 - 5 years relevant experience in Pharmaceutical Microbiology/Virology. Project management skills. Knowledge of regulatory and quality guidelines (GMP). Able to work in multidisciplinary teams. Excellent analytical and technical skills with strong support focus. Demonstrated initiative, and innovative process-oriented thinking within a team environment.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world. 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 diverse, talented, and committed people together.

Required Skills

• Data Analytics
• Driving Continuous Improvement
• Manufacturing Quality Control
• Method Validation
• Method Verification
• Process Optimization
• Technical Transfer

Employee Status: Regular

• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Hybrid
• Shift: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): Yes
• Job Posting End Date: 09/6/2026

*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.

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.