West Point, Pennsylvania

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.  

The Senior Specialist, Laboratory Information Management (LIMS) System & Automation is accountable 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.

Major Tasks

  • Processes change controls for the LIMS system following applicable procedures and documents changes in an electronic repository | 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 partnership 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 sponsor end users in the management and timely resolution of technical incidents through the standard incident and problem management process

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

  • Complete technical assignments independently once specific objectives have been defined


Education Requirement

  • Bachelor degree or higher in Biological or Computer Science, or related areas of study

Experience and Skills

Required

  • At least five years of prior work experience in the pharmaceutical/biotech industry.

  • LabWare v6 or higher 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

  • Working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical and vaccine products

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

  • Microsoft Access, Word and Excel

Preferred

  • Minimum two years of LIMS direct experience in the pharmaceutical environment | Entering, approving or reporting test results or updating master data templates

  • Programming (e.g. SQL, LIMS Basic)

  • Familiarity with other systems (e.g. SAP, Crystal Reports, MIDAS)

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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

Who we are …

We are known as Merck & Co., Inc., Kenilworth, 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. 

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R123042

West Point, Pennsylvania

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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