Automation Engineer - (Onsite)

Merck KGaA Darmstadt Germany - West Point, PA

Full-time

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Automation Engineer is responsible for the day-to-day operations support activities within a Good Manufacturing Practice (GMP) environment. This role involves problem-solving and developing both short and long-term solutions for automation issues, validating computer equipment, and maintaining current systems in compliance with GMP standards. The engineer will create and maintain standard operating procedures for automation systems, ensuring that all processes are efficient and compliant with regulatory requirements. In this position, the Automation Engineer will support all automation system components on the shop floor, directly contributing to manufacturing activities. Responsibilities include designing, implementing, testing, and closing out change controls for automation-related corrective actions and continuous improvement initiatives. The engineer will stay current with the latest automation technologies and trends, making recommendations for their adoption to enhance operational efficiency. The role requires working independently as well as collaboratively within a team, embodying values such as integrity, precision, accomplishment, motivational ambition, respect, and inclusion. Compliance with global policies, procedures, guidelines, and regulatory requirements is essential, as is the execution of current Good Manufacturing Practices (cGMP) in all job functions. The engineer will provide automation system support and expertise to assist in the manufacture of quality vaccine products, aligning with site priorities. Building relationships with functional counterparts and stakeholders is crucial for proactively identifying and resolving technical issues. The Automation Engineer will also lead or participate in investigations of automation incidents and problems to prevent recurrence, developing and implementing corrective actions as necessary. Additionally, the role includes providing off-site weekend and evening automation support for the company's 24/7 manufacturing operations.

Responsibilities

• Support all automation system components of the processes including on the shop floor support of manufacturing activities.
• Design, implement, test, and close out change controls for automation related corrective actions and continuous improvement initiatives.
• Stay current with latest automation technologies and trends and make recommendations for adoption.
• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP).
• Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
• Build relationships with functional counterparts and stakeholders to proactively identify and resolve technical issues.
• Lead or participate in investigations of automation incidents and problems to prevent recurrence, including the development and implementation of corrective actions.
• Provide off-site weekend/evening automation phone or on-site support for 24/7 manufacturing operations.

Requirements

• High School Diploma or Equivalent.
• 2 years experience in process automation or equivalent.
• Knowledge of computer system validation and regulatory GXP requirements.
• Understanding of S88 Batch Standard.
• Excellent communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.

Nice-to-haves

• Experience in pharmaceutical/biotechnology industry.
• Aseptic processing/sterile manufacturing experience.
• Technical and operational expertise in DeltaV DCS, PLC, SCADA, HMI, network infrastructure, SQL, etc.