Senior Specialist, Manufacturing Automation

Job Description
Position Description:
Senior Specialist, Manufacturing Automation
The Senior Specialist Manufacturing Automation person is primarily responsible for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility.
Responsibilities include: supporting commissioning and qualification efforts, troubleshooting equipment / automation issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality, IT, and engineering groups.
The Senior Specialist for Manufacturing Automation is responsible for providing automation technical support for the building.
Responsibilities may include, but are not limited to:

• Technical leadership for the assigned area and system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor support as needed.
• Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives.
• Provide technical guidance/support including authoring or review and approval of system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processes
• Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert
• Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.
• Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards
• Develops and supports corrective actions associated with automation related deviations/investigations
• Communicates periodically with immediate supervisor about status of area of responsibility.
• Support digital innovation initiatives on an as-needed basis.
• Initiate and lead collaboration within the Operations, Quality, and Technical organizations to resolve complex problems.
• 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. Oversees investigations of automation anomalies to prevent recurrence.
• On-floor support of manufacturing activities and periodic 24 x 7 on-call support.
• Identify and implement process/equipment improvements and manufacturing efficiencies.
• Maintain technical documentation.
• Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
• Responsible for Fermentation control Systems specific to areas of Seed and Production Fermentors and supporting tanks, supporting YSI, Raman, and Mass Spec equipment, supporting Bulk Chemical equipment, implementations of process change control, Delta V Network and troubleshooting in compliance with system life cycle (SLC), GMP, Data integrity, safety, and environmental regulations.
• Provides client services support for business area applications.

Working Relationships

• Reports to the Associate Director Manufacturing Automation
• Frequent interaction with employees from other departments
• Interacts with representatives from regulatory agencies and external suppliers

Position Qualifications:
Education Minimum Requirement:

• Bachelor's degree or higher in Engineering or Computer Science

Required Experience and Skills:

• Minimum five (5) years of experience in a production regulated industry
• Minimum of five (5) years of experience in a GMP manufacturing automation-related role and direct experience with SDLC and change controls
• Direct experience with at least two of the three platforms 1) Emerson DeltaV 2), Allen Bradley PLC (or equivalent), and 3) PI (or equivalent)
• Demonstrated ability to build relationships with team, peers and area leads
• Demonstrated leadership in achieving shared objectives in a matrix organization
• Strong understanding of manufacturing principles/ processes and ability to translate manufacturing requirements into Automation/digital solution
• Proven track record of analytical skills, problem solving and attention to detail
• Able to demonstrate the our companies Leadership Principles and Enterprise Leadership
• High personal integrity, credibility, and energy
• Excellent communication and influencing skills
• Strong written and verbal communication skills in English

Preferred Experience and Skills:

• Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88
• Data Integrity Acumen
• Experience in the following areas: DeltaV Version 14, DeltaV Live, SQL (basic querying)
• Lean Manufacturing /Six Sigma methodology.

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.
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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, 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".
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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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/22/2024
*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:05/22/2024
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:R286202