Job Description

The Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.

This Individual will provide leadership as the senior automation engineer for an aseptic manufacturing facility. Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups. Supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Provides direct support to Automation Lead including leading cross functional teams and providing direct guidance to the Automation team. Also provides technical coverage on automated systems.

Primary Activities include, but are not limited to:

• Understands and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations. Review and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.

• Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.

• 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.

• Assists in the Automation Lead in the training, development, motivation, and assignments for employees and contractors.

• Coordinates projects with staff group for timely implementation.

• Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems.

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

• Project coordination leadership and implementation of troubleshooting activities and change control.

• Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.

• On-floor support of manufacturing activities.

• Identify and implement process/equipment improvements and manufacturing efficiencies.

• Serves as liaison with corporate and divisional automation and IT groups.

Education Minimum Requirement:

• B.S., B.A., or greater preferably in Engineering, Science, or Information Technology

Required Experience and Skills:

• Minimum 2 yrs of experience in process automation or equivalent.

• Minimum of 3 yrs of aseptic processing/sterile manufacturing experience.

• Experience programming Emerson DeltaV or PLCs (ladder logic, HMIs, or SCADA) required.

• Computer validation and systems life-cycle development methodology experience required.

Preferred Experience and Skills:

• Experience working with Information Technology teams.

• Minimum of 3 yrs of aseptic processing/sterile manufacturing experience.

• Experience with regulatory audits and working knowledge of data integrity principles.

• Understanding of Lean Manufacturing /Six Sigma methodology.

• Strong leadership, interpersonal and communication skills.

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. VETJOBS #EBRG

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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".

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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.

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Relocation:

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Requisition ID:R306223