Sr. Spclst , Manufacturing Automation

Merck & Co.-posted 3 months ago
$114,700 - $180,500/Yr
Full-time • Senior
Onsite • Durham, NC
Chemical Manufacturing
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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. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Senior 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.

  • 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.
  • Provides client services support for business area applications.
  • Serves as liaison with corporate and divisional automation and IT groups.
  • Bachelor's degree or higher in Engineering or Computer Science.
  • 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 company's Leadership Principles and Enterprise Leadership.
  • High personal integrity, credibility, and energy.
  • Excellent communication and influencing skills.
  • Strong written and verbal communication skills in English.
  • Data Integrity Acumen.
  • Lean Manufacturing /Six Sigma methodology.
  • Medical, dental, vision healthcare and other insurance benefits (for employee and family).
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, and compassionate and sick days.
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