Job Description

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.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Our company's campus in Elkton, Virginia is growing and has a bright future. At Elkton, we currently have multiple positions open in the Laboratory Automation & IT group. The Laboratory Automation & IT group is tasked with transforming the lab organization into an integrated and efficient organization that connects lab data, processes, systems, and instruments with enhanced digital capabilities and compliance. Major compliance initiatives include data integrity and security.

The Lab Automation & IT group supports Good Manufacturing Practices (GMP) regulated laboratories as well as a subset of systems in production areas. Systems include laboratory instrumentation systems as well as limited support of informatics systems.

The ideal candidate has a mixture of laboratory instrumentation knowledge and experience (lab work experience and knowledge are an advantage) and strong computer science experience and knowledge. Candidates with strengths heavily leaning in one of these areas are considered, but the strong candidates have experience supporting GMP laboratories.

Responsibilities

* Effectively manage projects from start-to-finish with minimal supervision. Act as primary point-of-contact and/or lead for computerized laboratory systems/instrument projects.
* Projects include serving as computerization specialists for new or upgraded laboratory instruments. Tasks may include, but not limited to: participation in writing system requirements, configuring system software, development of software testing scripts to verify requirements are met, etc.
* Communicate with instrument end-use expert (chemist, biologist, engineer, etc.) to understand the desired functionality of the system. Determine the best process and system configuration to meet business functions and our company's compliance requirements and specifications.
* Translate user requirements and compliance requirements into technical specifications, develop value-added system solutions, and develop software testing steps to verify solution meets requirements.
* Write standard operating procedures for administration and or software use of computerized laboratory systems.
* Work and collaborate with a complex network of teams and individuals throughout all levels of the company (including those from laboratories, other IT technical support teams, corporate governing teams) as well as external groups such as vendors.
* Provide administrative support to system users (e.g. account creation, password resets, etc.).
* Provide documentation/technical input during inspections and audits (Regulatory and Internal).
* Identify and leverage opportunities to continually improve the quality and effectiveness of data management systems, processes, and standards.
* Participate in the design of the processes, and the implementation of data integrity improvements.
* Support change management for data integrity and participate in maintaining a strong data integrity culture.

Example task

For a new instrument, read and review user manuals and obtaining minimal training on a system. Work with laboratory chemist/biologist on how the instrument is used, and then learn how the system software operates. Determine data integrity and security gaps to our company standards and requirements. Determine the configuration of the system software, operating system, adjunction systems or software, and business processes to satisfy requirements and mitigate risk. Configure system (instrument application, windows OS, and Desktop Secure). Write testing documents to verify the system meets requirements. Execute portions of such testing in cooperation with laboratory subject matter experts.

Qualifications

Education Minimum Requirement:

* BS degree required, with concentrations in Computer Science, Science, Engineering or related field

Required Experience and Skills:

* A minimum of four years of relevant experience.
* Technical knowledge of computerized systems / IT
* Computer coding, computer administration, or computer system implementations
* Demonstrated strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
* Self-motivated to take ownership and accountability of issues and drive them to completion.

Preferred Experience and Skills:

* Knowledge of GxP and regulatory requirements for pharmaceuticals
* Applied professional work experience in one of the following areas (a or b):

a) GMP regulated area such as pharmaceutical laboratory, manufacturing, or technical support

b) Computer systems with controls for a regulated industry

* Administration or implementation of Laboratory or computer-controlled instrumentation, LIMS, or related industry system
* Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes
* Familiarity with System Development Life Cycle methodologies

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network thats committed 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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2
Requisition ID:R61599