Senior Laboratory Systems Specialist

MSD Malaysia; Dunboyne; On-site; EUR 90,000 - 120,000; Full time

Job summary

MSD Malaysia is seeking a Senior Laboratory Systems Specialist to lead data management and instrument control systems at our Dunboyne site. The role acts as SME for LIMS, Empower, MODA, and related solutions, driving digital initiatives and system harmonization within a GMP framework.

You will oversee qualification/validation, technical transfers, and NPIs, while ensuring SDLC standards and audit readiness.

Qualifications

• Bachelor’s degree in a technical or scientific discipline (e.g., Biochemistry, Chemistry, Computer Science, Engineering) required.
• Hands-on SME knowledge configuring, building and maintaining laboratory systems (LIMS, MODA, Empower) preferred.
• Strong understanding of analytical methodologies used in biologics testing and data integrity concepts.

Responsibilities

• Lead projects for instrument control and data management systems (LIMS, Empower, MODA, SoftMaxPro, LabX) and harmonize site systems with global standards.
• Provide SME oversight for qualification/validation, technical transfers, and NPI support.
• Ensure cGMP compliance and SDLC governance, including change control and document management.
• Mentor and coach Laboratory Systems team; communicate site progress to leadership.

Skills

Problem Solving

Communication

Strategic Mindset

Adaptability

Analytical Method Development

Bioanalytical Method Development

Driving Continuous Improvement

GMP Compliance

Instrumentation

Laboratory Management

Method Development

People Leadership

Quality Leadership

Quality Standards

Regulatory Requirements

Strategic Thinking

Technical Transfer

Technology Transfer

Education

Bachelor’s degree in a technical or scientific discipline

Tools

LIMS (GLIMS)

empower

MODA

SoftMaxPro

LabX

Digital Method solutions

Job description

Job Description We are seeking a highly skilled and collaborative Senior Laboratory Systems Specialist to join our Quality Operations team. In this pivotal role, you will serve as the Subject Matter Expert (SME) and project lead for data management and instrument control systems across our Dunboyne site. You will work cross-functionally to drive operational readiness, lead innovative digital initiatives, and support our biologics pipeline—including New Product Introductions (NPI) and Technical Transfers. If you are passionate about digital lab solutions, system harmonization, and operational compliance in a fast-paced GMP environment, this role offers an exceptional platform to grow your career and influence our digital strategy.

Key Responsibilities

System Ownership & Project Leadership

Serve as the site Subject Matter Expert (SME) and lead key projects for laboratory instrument control and data management systems, including LIMS (GLIMS), Empower, MODA, SoftMaxPro, LabX, and Digital Method solutions. Partner and build strong relationships with local Lab IT Systems teams and global System Business Owners to align systems with global standards. Support business processes and integration requirements, including data mapping translations for adjacent ERP systems and Middleware. Develop strategies and drive site activities for the harmonization and standardization of laboratory systems, including system maintenance, master/static data creation, and consistent data reporting.

Technical Transfers & Commercial Operations

Deliver SME oversight for qualification/validation, technical transfers, and routine commercial testing. Lead and support innovative system-related projects to facilitate New Product Introductions (NPI) and the commercialization of our biologics pipeline. Assist the laboratory team in resolving day-to-day and systemic issues related to the testing of raw materials, in-process drug substances/drug products, final drug products, stability samples, cell banking, and environmental and utility monitoring.

Compliance & Quality Assurance

Ensure all laboratory systems perform in strict compliance with cGMP, global regulatory guidelines, and Systems Development Life Cycle (SDLC) standards (including change control and document management). Maintain continuous audit and inspection readiness for laboratory systems. Represent the systems during regulatory audits by providing direct technical support and SME coaching. Implement industry best practices to support sample management, analytical testing, and validation workflows.

People & Culture

Provide coaching, mentorship, and development support to the Laboratory Systems team to foster a high-performance, agile organizational culture. Collaborate cross-functionally to champion a culture of Quality, EHS (Environment, Health & Safety), Learning, and Continuous Improvement. Effectively communicate site achievements, progress, and system-related challenges to leadership.

Qualifications, Skills & Experience

Education

A Bachelor’s degree (or higher) in a Technical or Scientific discipline (e.g., Biochemistry, Chemistry, Computer Science, Engineering, or a related field).

Technical & Systems Expertise

Proven, hands-on SME knowledge in configuring, building, and maintaining key laboratory computerized systems, specifically LIMS, MODA, and/or Empower. A strong understanding of analytical methodologies utilized in biologics testing (e.g., HPLC, ELISA, SDS-Page, PCR, capillary electrophoresis, bioassays, and compendial assays). Familiarity with data integrity concepts, SDLC principles, and data mapping integrations between laboratory systems and external systems/ERP/Middleware.

Regulatory & Compliance Knowledge

Demonstrated experience working in a cGMP-regulated Pharmaceutical or Biopharmaceutical manufacturing environment is highly desirable. In-depth knowledge of global compendial regulations and guidance (including GMP, ICH, and USP), particularly as they relate to analytical method development, validation, and system compliance.

Core Competencies

• Problem Solving & Autonomy: Strong organizational skills with the ability to manage multiple complex priorities, drive proactive programs, and elevate issues timely and effectively.
• Communication: Exceptional written and verbal communication skills, with the ability to translate complex technical/system requirements to non-technical stakeholders.
• Strategic Mindset: A comprehensive, end-to-end understanding of business processes and the product lifecycle to support digital strategy decision-making.

Required Skills

• Adaptability
• Analytical Method Development
• Bioanalytical Method Development
• Driving Continuous Improvement
• GMP Compliance
• Instrumentation
• Laboratory Management
• Method Development
• People Leadership
• Quality Leadership
• Quality Standards
• Regulatory Requirements
• Strategic Thinking
• Technical Transfer
• Technology Transfer

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/28/2026 *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.