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 escalate 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:

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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