Requisition ID: QUA008150
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Laboratory Information Systems (LIMS) Specialist is responsible for supporting site business in updating master data for new and existing products, updating master data for new and existing 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 and Support Center 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.
Education Minimum Requirement: Bachelor's Degree or higher in Biological or Computer Science
Required Experience and Skills:
- A minimum of 2 years of LIMS hands on experience in the pharmaceutical environment; entering, approving or reporting test results or updating master data templates.
- 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:
- Use of LabWare v6 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.
- Use of SQL*LIMS including template building
- Programming experience (E.g. SQL, LIMS Basic)
- Experience using Microsoft Access, Word and Excel
- Familiarity with other systems (E.g. TrackWise, SAP, Crystal Reports, MIDAS)
- Ability to write UAT scripts and support execution of UAT adhering to SDLC
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Quality Operations
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck
Nearest Major Market: Philadelphia