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Job Description

Essential functions include, but not limited to:

Working within the Site DMO team, provides key automation support for various manufacturing systems such as PLC, DCS, MES, IT, and OEM systems in Manufacturing Operations. Responsible for resolution of significant automation issues and maintenance of automation systems in compliance with cGMPs, SLC, safety, and environmental regulations. Provides guidance on process control, data collection techniques, and failure mode and effects analysis. Develops strategies to optimize and ensure quality and stability of automation systems though future expansion, replacement, or upgrade. Supports preparation of digital/automation cost information to support necessary plans. Lead automation related investigations into Atypical Production Reports (APRs) and implement the corrective actions. Other responsibilities may include working as a representative of a startup or existing production team providing technical / leadership assistance in fulfilling the automation requirements for the team. For various project assignments / initiatives, the automation team member is responsible for working closely with various site / central groups in maintaining manufacturing requirements. Group supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Responsibilities include providing automation leadership/support on limited shifts/weekend in support of Manufacturing Operations. Responsibilities may include coaching responsibilities and management of contract resources.

Primary Activities include, but are not limited to:

+ Leads and provide key shopfloor support for various manufacturing systems such as PLC, DCS, MES, IT, Inspection, Serialization and OEM systems within Manufacturing Operations. Serves as interface between operations and other digital support organizations to resolve issues impacting shopfloor operations. Collaborates with Operations, Quality, Maintenance and other technical groups to resolve complex problems and provide innovative solutions. Participates in daily tier meetings and governance processes as necessary

+ Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. Identifies and implements process/equipment improvements and manufacturing efficiencies. Provides guidance on process control, data collection techniques, and failure mode and effects analysis. Prepares automation cost information to support necessary plans.

+ Understands and supports all GMPs, safety, and environmental regulations. Maintains shopfloor systems in compliance with SLC, cGMPs, safety, and environmental regulations. Responsible for providing subject matter expertise knowledge for new and existing equipment following current regulator ion change controls and qualification requirements approach. Offers expertise in the subject matter for both new and existing equipment, adhering to current regulatory change controls and qualification requirements. Provides leadership in the analysis of system data integrity requirements and system security. Periodically authors and reviews system documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. Participates in audits and training programs as SME in appropriate areas of knowledge and responsibility.

+ Responsible for recognizing and addressing irregularities in shopfloor systems and automated equipment. This involves troubleshooting issues, devising solutions, and implementing measures to rectify or prevent these anomalies. In atypical shopfloor system incidents, leads/supports investigations to determine root cause. Formulates and supports corrective measures to prevent recurrence. Addresses compliance requirements to document investigations and corrective actions.

+ Manages shopfloor system project activities following approved business processes to deliver results that are quality engrained, right first time, on-time with schedulerequirements, reconciled tothe budget, andmeet allQuality/Safety requirements. Deliver project plans, whichhave been developed andalignedwithall key stakeholders. Lead projects by engagingteammembers,settingclearexpectations,utilizingstrongcommunicationskills andexercisingcleardecision-making. Regularly and clearly communicate project plans, risks andstrategytoall key stakeholders,customersandgovernance committees. Prepares automation cost information to support necessary project plans.

+ Educates teammates and colleagues on manufacturing computer systems to ensure the efficient operation of various automated processing and information technology systems. This involves sharing knowledge on engineering principles and other areas of expertise as needed, serving as a subject matter expert for shopfloor control systems, creating knowledge-based problem resolution articles to share with colleagues, coordinating applicable training events and proactively sharing knowledge and experiences.

+ Manages repository for production equipment/system qualified automation programs and files with associated metadata. Ensures appropriate backups are maintained for recovery purposes. Ensures accuracy of site system inventory and that inventory data is current.

+ Responsibilities may include providing coaching leadership to other team members while exhibiting appropriate our Company's Leadership standards. May manage selected external contractors - monitoring performance and ensuring contractual obligations are met.

+ Role requires limited off shift/weekend support and participation in an on-call rotation.

Education Requirement:

+ B.S., B.A, or M.S. in Information Technology, Science, Engineering or related technical field.

Required Experience & Skills:

+ Minimum of eight years' experience in IT/Automation support of manufacturing or process engineering or equivalent.

+ Working knowledge of the regulatory requirements for pharmaceutical applications.

+ Working knowledge of PLCs, HMIs, Servo-Drives and Control Systems.

+ Effective leadership, interpersonal and communication skills (written and oral) are required.

+ Experience in computer validation and systems lifecycle development methodology.

+ Experience authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents.

+ Demonstrated ability to lead key projects across multiple site disciplines.

Desired** **_:_

+ Highly desired are skills in packaging technology equipment, Vision Systems, barcode systems, reject/verification processes, Serialization, MES, IT, and OEM equipment.

+ Experience with Continuous Improvement, Lean Manufacturing, Problem Solving and Right First-Time methodologies.

+ Data Integrity and Cyber Security acumens are desired.

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:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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

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, Monday - 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”.

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Applied Engineering, Audit Management, Automation, Business Processes, Business Process Improvements, Communication, Corrective Action Management, Data Integrity, Data Management, Environmental Regulations, GMP Compliance, Mechatronics, Preventive Maintenance, Problem Management, Process Engineering, Project Planning, Quality Management, Real-Time Programming, Regulatory Requirements, Servo Motors, Software Development Life Cycle (SDLC), Workplace Training

Preferred Skills:

Job Posting End Date:

06/6/2025

*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:** R350583