Merck KGaA Darmstadt Germany-posted 3 months ago
$114,700 - $180,500/Yr
Full-time • Mid Level
Onsite • West Point, PA
Chemical Manufacturing

Our Digital Manufacturing Operations team owns and manages automation systems to manufacturing our vaccine 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. The Senior Specialist is Manufacturing Automation, is responsible for: i) management of all automation process control systems in a live virus vaccine manufacturing facility, ii) leading or mentoring a small team of automation engineers, and iii) technical and compliant oversight on shop floor support, deviation investigations, change management, system administration, and management of small projects.

  • Direct/prioritize workload activities of a professional staff of 2 - 4 engineers to provide process automation support to enable the reliable and compliant supply of vaccines.
  • Possesses strong knowledge and experience in Distributed Control System (DCS) and/or has led mid to large projects involving automated systems such as DeltaV, PLC, BUS, OPC technologies.
  • Knowledgeable of S88 Batch Standard desirable.
  • Has strong problem-solving skills to investigate automation related incidents and propose sound solutions to improve the system.
  • Motivates staff in a manner that fosters an integrated team environment.
  • Understands and supports all GMPs, safety, and environmental regulations.
  • Responsible for maintaining system development lifecycle deliverables, including change control and ensure they are inspection ready.
  • Supports process automation inquiries during internal and external audits/inspections, and must, therefore, be able to speak knowledgeably about automation, process and cGMP details of the manufacturing operations.
  • Analyzes complex business requirements using tools and techniques and identifies internal/external solutions to meet these requirements.
  • Communicates regularly with the other functional groups (operation, technical, and quality representatives) within the area on priorities, status and escalations.
  • Familiar with six-sigma and lean manufacturing principles with an ability to convert business logic and requirements into detailed system requirements.
  • Performs preventive maintenance, performance monitoring, and revises or develops automation Standard Operating Procedures to keep the system and the user operability in an optimal state.
  • Leads complex software system testing and validation procedures and oversee system configuration and documentation.
  • Provides On-the-floor troubleshooting support of manufacturing activities.
  • Provides hands-on training and serves as a technical resource for other engineers.
  • A minimum a B.S degree in engineering, computer science/electrical/chemical/mechanical, or equivalent.
  • Minimum five (5) years in pharmaceutical process automation or equivalent.
  • Experience in Automation Platforms such as DCSs (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, Data Historians (OSI PI), Batch Reporting (Informetric Info Batch).
  • Demonstrated ability to communicate effectively and to build relationships with team, peers and area leaders.
  • Knowledgeable of cGMP's, safety guidelines, engineering standards, computer system validation and regulatory guidelines.
  • Experience leading or managing teams in a project or an operation environment.
  • 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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