Job Description

Laboratory Information System (LIMS) & Lab Automation Specialist

The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in updating master data for new and existing products and analysis 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.

Provide technical support for LIMS to site. 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.

Provides 100% second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, completeness.

Support the business in the creation and updating of training materials as changes to system occur.

Incumbent must complete technical assignments independently once specific objectives have been defined.

Minimum Education Requirement:

Bachelor's Degree or higher in Chemistry, Biological or Computer Science

Minimum Requirement:

Flexible working hours (up to ~25%/week) are required to support collaboration with project teams in US East coast, especially during initial training period.

A minimum of 2 years of LIMS hands on experience in the pharmaceutical environment. 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, reagent and instrument managers, reports and query tools is preferred.

Candidate must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.

Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.

Preferred Experience and Skills:

Familiarity with other compliant industry platforms/systems, electronic document management systems, change control systems)

Ability to write UAT scripts and support execution of UAT adhering to SDLC

Experience with LIMS/Labware v8 system use. System deployment, query and reporting development, and administration experience preferred. Programming/Administrator experience in LIMS preferred.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe

Who we are ...

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 ...

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--and 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's 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: No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 4