Merck KGaA Darmstadt Germany - West Point, PA

posted 3 months ago

Full-time
Onsite - West Point, PA
Chemical Manufacturing

About the position

The automation engineer is responsible for day-to-day operations support activities including problem solving, developing short and long-term solutions for automation problems, validating computer equipment, maintaining current systems in a GMP state, and creating/maintaining standard operating procedures for the systems. This role requires the engineer to support all automation system components of the processes, particularly on the shop floor during manufacturing activities. The engineer will design, implement, test, and close out change controls for automation-related corrective actions and continuous improvement initiatives. Staying current with the latest automation technologies and trends is essential, as is making recommendations for their adoption. The engineer will work both independently and as part of a team, embodying values such as Integrity, Precision, Accomplishment, Motivational Ambition, Respect, and Inclusion. Compliance with Global Policies, Procedures, and Guidelines, as well as regulatory requirements, is crucial, particularly in executing current Good Manufacturing Practices (cGMP) in all job functions. The automation engineer will provide system support and expertise to assist in the manufacture of quality vaccine products, ensuring that site priorities are met. Building relationships with functional counterparts and stakeholders is necessary to proactively identify and resolve technical issues. The engineer will also lead or participate in investigations of automation incidents and problems to prevent recurrence, including the development and implementation of corrective actions. Additionally, the role requires providing off-site weekend/evening automation phone or on-site support for our 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 the latest automation technologies and trends and make recommendations for adoption.
  • Work independently and as a team member, adhering to company values.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP).
  • Provide automation system support and expertise to assist in the manufacture of quality vaccine products.
  • 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 the pharmaceutical/biotechnology industry.
  • Aseptic processing/sterile manufacturing experience.
  • Technical and operational expertise in DeltaV DCS, PLC, SCADA, HMI, network infrastructure, SQL, etc.
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