Merck Jobs

Job Description

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

GENERAL SUMMARY:

Our Digital Manufacturing Operations (DMO) Senior IT Specialist - Manufacturing Automation (MES Engineer) is responsible for supporting the Manufacturing Execution Systems (MES) that directly support the Maurice R. Hilleman Vaccine Manufacturing Facilities (our Manufacturing Division, Durham), while actively participating in and embracing an empowered team culture.

The Sr. Specialist will lead a small elite team of like-minded Subject Matter Experts (SME) specific to our Manufacturing Division Durham supporting the MES application and its operational use in manufacturing production. The Sr. Specialist will partner with site manufacturing and automation leads, as well as corporate IT groups, to support multiple MES environments. The Sr. Specialist will be required to understand and promote IT strategies and initiatives as they relate to the MES environments.

GENERAL PROFILE:

• Our Digital Manufacturing Operations Senior IT Specialist - Manufacturing Automation (MES Engineer) must be able to work independently and be comfortable reaching across functional and geographical areas to collaborate with IT colleagues, third party solution providers and contractors.

• Work flexibly and collaboratively as a team leader or supporting personnel in an inclusive, dynamic operating environment.

• Works in an empowered, self-directed culture with independent decision making in the planning, coordination, and execution of multiple activities and projects.

• Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.

• Responsible for effective document review, approval, and conformance to our Company Manufacturing Standards, our Manufacturing Division Quality Policies, cGMPs for the generation and approval of the required documentation and testing.

• Develops, reviews, and approves site procedures and reviews updates to divisional guidelines.

• Responds to divisional initiatives and Quality Directives.

• Analyzes and solves problems using standard problem-solving processes.

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

• Provides training sessions to our Company personnel pertaining to MES requirements.

BUSINESS EXPERTISE:

• Understands the fundamental business drivers for the company; and uses this knowledge in own work.

• Understands and applies regulatory / compliance requirements.

FUNCTIONAL EXPERTISE:

• Our Digital Manufacturing Operations Senior IT Specialist - Manufacturing Automation (MES Engineer) responsibilities include:

• Provide 24 x7 on-call support for MES operational and system issues as a member of a rotating support group.

• Manage and perform change controls according to site procedures for master data and MES system parameters.

• Partners with corporate IT teams to resolve complex issues and ensure proper root cause is identified and preventative actions are implemented.

• Collaborate with MES Engineers at other sites to share best practices and discuss common issues.

• Creating and maintaining alignment between Master Batch Records (MBRs) and corresponding SAP Production Variant and DeltaV recipes.

• Maintaining the MES in compliance with Current Good Manufacturing Practices (cGMPs).

• Perform System Life Cycle upkeep of new and existing MES environments in accordance with Computer Software Assurance (CSA)

• Lead the definition, SDLC documentation and validation of new master data and system parameters as a member of a team responsible for new products/MBR’s.

• Lead the definition, SDLC documentation and validation of master data and system parameters changes required for MES system upgrades.

• Reviewing MES system and SDLC documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.

• Developing and supporting corrective actions for investigations related to MES.

• Participation in Kaizen events.

• SOP development and review.

• Direct support of regulatory inspections and audits.

• Direct support of validation activities and all other associated Quality functions.

• 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.

• Reviews and approves SOPs as appropriate.

• Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate.

• Performs special quality projects / investigations as requested by Senior Management.

IN ORDER TO EXCEL IN THIS ROLE, YOU WILL MORE THAN LIKELY HAVE: ​

• 8-10 years of experience in Vaccines / Pharmaceutical Manufacturing front line supervision and/or project/automation/IT support.

• Proven record of proficiencies associated with business analysis on small sized projects.

• Strong hands-on MES technical experience working on Werum, but also interfacing to other manufacturing systems.

• Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles. Excellent facilitation, problem solving, and decision-making skills.

• Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.

• Proven facilitation, meeting/workshop management, project management and change management skills are essential, along with excellent written and oral communication skills, as well as strong presentation skills.

• Familiarity with implementation of Manufacturing Execution Systems and associated business benefits. Project Management experience preferred.

INFLUENCE / DECISION MAKING / PROBLEM SOLVING:

• This position has an influence on the continuous acceptance of existing and new products at the Durham site through support of MES implementation and maintenance that lead to the expansion of the Durham product portfolio.

• The individual in this role is required to make real time decisions in a time constrained environment on the handling of data, configuration, implementation, and changes to ensure the appropriate documentation and testing is performed.

• This role requires interactions with personnel at all levels across multiple functional areas and above site teams to ensure timely completion of Manufacturing and Information Technology responsibilities.

• Development and maintenance of robust site-wide systems to govern the MES maintenance / control / and configuration data.

REQUIRED EXPERIENCE AND SKILLS:

• Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management

REQUIRED EDUCATION:

• BS in Engineering, Computer Science, or other technical degree. MS in Computer Science or related field/MBA is a plus.

#eligibleforerp

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

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Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

07/5/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 07/05/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R283460