Job Description

The Laboratory Information Systems (LIMS) Specialist is responsible for:

• Supporting site business in building and maintaining master data including materials, sample plans, product specifications, analysis, process schedules, other associated master data tables and maintaining system documentation.
• Processes change controls for the LIMS system following applicable procedures and documents changes in an electronic repository. The projects assigned are technical in nature and require a working knowledge of analytical testing methods and GMP Compliance.
• Ensure on time implementation of LIMS static data changes through collaboration with business areas in support of requirements definition, functional design, and master data configuration.
• Provides second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, and completeness.
• Provide technical support for Labware LIMS. Act as first level diagnostic of incidents and support end users in the management and timely resolution of technical incidents through the standard incident and problem management process.

Qualifications

Minimum Education Requirement:

• Bachelor\xe2\x80\x99s Degree or higher in Computer Science, BS Biology, Microbiology, Pharmacy, Chemistry, Engineering or demonstration of the applicable experience

Minimum Requirement:

• A minimum of 2 years of Labware LIMS (v6 or higher) hands on experience in the pharmaceutical environment.
• Experience and demonstrated skills in master data management in Labware LIMS to support Release testing, Stability, Environmental Monitoring, and integration to external systems such as SAP, Empower and other instruments.
• Experience with use of LabWare LIMS including but not limited to knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
• LIMS Basic experience to build or update component calculations and format calculations is required.
• Candidate must have knowledge of regulatory expectations for the manufacture and testing of vaccines, biological products, or sterile pharmaceutical products.
• Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
• Incumbent must complete technical assignments independently once specific objectives have been defined.
• Possesses a technical aptitude for computerized systems, analytics, and method evaluations.
• Flexible working hours (up to ~25%/week) are required to support collaboration with project teams in US East coast, especially during initial training period.

Preferred Experience and Skills:

• Familiarity with other compliant industry platforms/systems, electronic document management systems, change control systems.
• Ability to write test scripts and support execution of validation protocols adhering to SDLC.
• Use of databases, Oracle, data trending and basic coding capability (such as SQL, VBA)
• Development/validation of Microsoft Excel workbooks for GMP use.

Who we are \xe2\x80\xa6

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for \xe2\x80\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
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.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Merck Sharp & Dohme