Senior Specialist- Manufacturing Automation

Merck & Co. - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The Automation Support Engineer within the Digital Manufacturing Operations team is responsible for providing key automation support for various manufacturing systems, ensuring compliance with regulations and optimizing automation systems for quality and stability. This role involves troubleshooting significant automation issues, leading investigations into production anomalies, and collaborating with multiple teams to enhance manufacturing processes. The position requires a blend of technical expertise, leadership, and communication skills to effectively manage automation projects and support manufacturing operations.

Responsibilities

• Lead and provide key shopfloor support for various manufacturing systems such as PLC, DCS, MES, IT, Inspection, Serialization and OEM systems within Manufacturing Operations.
• Serve as interface between operations and other digital support organizations to resolve issues impacting shopfloor operations.
• Collaborate with Operations, Quality, Maintenance and other technical groups to resolve complex problems and provide innovative solutions.
• Participate in daily tier meetings and governance processes as necessary.
• Evaluate automated and information technology systems and develop strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.
• Identify and implement process/equipment improvements and manufacturing efficiencies.
• Provide guidance on process control, data collection techniques, and failure mode and effects analysis.
• Prepare automation cost information to support necessary plans.
• Understand and support all GMPs, safety, and environmental regulations.
• Maintain shopfloor systems in compliance with SLC, cGMPs, safety, and environmental regulations.
• Provide subject matter expertise knowledge for new and existing equipment following current regulation change controls and qualification requirements approach.
• Lead the analysis of system data integrity requirements and system security.
• Author and review system documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.
• Participate in audits and training programs as SME in appropriate areas of knowledge and responsibility.
• Recognize and address irregularities in shopfloor systems and automated equipment, troubleshooting issues and implementing solutions.
• Lead/support investigations into atypical shopfloor system incidents to determine root cause and formulate corrective measures.
• Manage shopfloor system project activities following approved business processes to deliver quality results on time and within budget.
• Communicate project plans, risks, and strategies to all key stakeholders, customers, and governance committees.
• Educate teammates and colleagues on manufacturing computer systems to ensure efficient operation of automated processing and information technology systems.
• Manage repository for production equipment/system qualified automation programs and files with associated metadata.

Requirements

• Bachelor's degree in Information Technology, Science, Engineering or related technical field.
• Minimum of 8 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).
• 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.

Nice-to-haves

• 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.

Benefits

• Health insurance
• Dental insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development opportunities