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Merck Specialist, Business Consulting in Durham, North Carolina

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

GENERAL SUMMARY :

Our Manufacturing Division IT Specialist MES Author / Shop Floor Hardware support is responsible for conducting the Manufacturing Execution System (MES) Master Batch Record updates and supporting the (computerized) systems and peripherals used to access automation and IT systems that directly support Durham site shop floor manufacturing, while actively supporting, participating in and embracing an empowered team culture.

GENERAL PROFILE:

  • Requires working knowledge and experience in MES and/or Shop Floor Hardware

  • Builds knowledge of the company, processes and clients and/or customers

  • Solves a range of MES and Shop Floor hardware problems

  • Analyzes possible solutions using standard procedures

  • Receives a minor level of guidance and direction

  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

BUSINESS EXPERTISE:

  • Applies working knowledge of company business developed through education or past experience

  • Understands and applies regulatory/ compliance requirements relative to their role

FUNCTIONAL EXPERTISE:

  • The Specialist MES Author / Shop Floor Hardware support will be responsible for supporting the manufacturing batch record and lab shop floor hardware at the Durham site including the following:

  • Providing technical leadership for the assigned area and system(s) to ensure a compliant and reliable supply of product and on time project execution with production shop floor support as needed.

  • Providing technical support including authoring or review of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, System Development Life Cycle (SDLC) documents, and other key automation related processes.

  • Developing, reviewing and approving of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards.

  • Leading problem solving practices to identify and resolve technical and operational problems; able to collaborate with peers to resolve problems that cross into inter-related units.

  • Leading the proper maintenance and operation of tablets, desktops, laptops, peripherals, printers, scanners, production phones and communications equipment, and local network connections for computer equipment used in the manufacture of product in GMP manufacturing facilities, included in classified space.

Providing support for cGMP and non-cGMP business applications, including (but not limited to):

  • Site Services: Visitor Watch, Camera System “Milestone”, Badging System, GMP clocks, conference room audio visual

  • Production: MES, PAS-X, SAP, Citrix, My-Apps, GLIMS, Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms

  • Supports hardware installation, troubleshooting and repair of PSU, RAM, hard drives, motherboards, touch screens, POS devices, Tablets, ELO touch screens, bar code Scanners, badge readers, and Printers.

  • Support Account administration for service accounts, machine accounts group administration (MES, admin groups for workstation and server administration) for tablets, desktops, and laptops used in GMP manufacturing facilities.

  • Participating in site and department tier structure, leading a tier meeting for FTEs supporting shop floor hardware.

  • Evaluating automated and information technology systems, and developing strategies to optimize and ensure quality and stability of these systems through future expansion, replacement, or upgrade. Interacts with above-site IT groups to align solutions with current corporate IT platform and guidelines.

  • Leading investigations of problems and anomalies and implement corrective actions to prevent recurrence.

  • Participating in audits and training programs in the area of responsibility.

  • Developing, maintaining, and reporting metrics to trend problems and identify solutions.

  • Leading contract employees to provide the above, in compliance with safety and cGMP procedures.

  • Managing vendors and contract employees for conduit, network drop, and equipment installations, and incursion management for work in classified space, coordinating with the Quality unit.

  • Other duties requested by Management.

Education Minimum Requirement:

  • High School Diploma

  • College courses preferred

Required Experience and Skills:

  • Minimum of 5 years experience in IT and Windows Operating System.

  • Working knowledge of Purpose and Use of Manufacturing Execution Systems

  • Leading the proper maintenance and operation of tablets, desktops, laptops, peripherals, printers, scanners, production phones and communications equipment, and local network connections for computer equipment used in the manufacture of product in GMP manufacturing facilities, included in classified space.

  • Providing technical leadership for the assigned area and system(s) to ensure a compliant and reliable supply of product and on time project execution with production shop floor support as needed.

  • Participating in audits and training programs in the area of responsibility.

  • Providing technical support including authoring or review of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, System Development Life Cycle (SDLC) documents, and other key automation related processes.

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 that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at staffingaadar@merck.com

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

EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R25505

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