Senior Specialist, Manufacturing Automation

MSDUpper Gwynedd Township, PA
$117,000 - $184,200Hybrid

About The Position

Our Digital Manufacturing Operations organization supporting the dynamic West Point site is seeking a Senior Specialist in Process Automation to join the team. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and collaboration of individuals. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. This role will lead a team of engineers in providing automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe. Key responsibilities of this role include: -- Lead a team of 3 engineers in providing process automation support for our Hepatitis A vaccine manufacturing facility to enable reliable and compliant manufacturing/ supply of vaccines. -- Direct/ prioritize workload activities of the process automation team, responsible for: Compliance with System Development Life Cycle (SDLC), GMP, safety and environmental regulations. Collaboration with other functions within the Integrated Process Team through ownership of automated systems and Subject Matter Expertise Support of manufacturing activities on the shop floor Design and implementation of process control improvements/ corrective actions Troubleshooting and resolution of automation issues/ events Participation in deviation investigations Administration of automated control systems, sustaining state of Permanent Inspection Readiness -- Apply leadership skills and sensibilities to foster a high performing, collaborative team environment -- Serve as primary Subject Matter Expert and represent automation function on IPT leadership team. ---Communicate daily with the business, technical and quality representatives through tier process -- Support process automation inquiries during internal and external audits/ inspections and must therefore be able to speak knowledgeably about automation in association with the cGMP processes and manufacturing operations -- Continuously evaluate automated systems and develop strategies to optimize and ensure quality/ stability of systems through future expansion, replacement, or upgrade. -- Directly support site and global initiatives with respect to digital transformation and improving how West Point Digital Manufacturing Operations does business

Requirements

  • Bachelor's of Science degree in Engineering, Computer Science or related field.
  • Technical and operational expertise in the following disciplines desired: DeltaV DCS, PLC, SCADA, HMI, Computer System Validation (CSV) and System Development Lifecycle (SDLC)
  • Strong technical writing capabilities
  • 7+ years in process automation, IT/ OT or equivalent
  • Knowledgeable of S88 Batch Standard.
  • Knowledgeable of regulatory GxP requirements.
  • Knowledge of equipment and process validation
  • Problem Solving (technical and non-technical)
  • Strong communication and interpersonal skills to interface effectively with colleagues from all levels of the organization, and with external customers and vendors

Nice To Haves

  • Pharmaceutical and Biotechnology manufacturing process experience is strongly preferred.

Responsibilities

  • Lead a team of 3 engineers in providing process automation support for our Hepatitis A vaccine manufacturing facility to enable reliable and compliant manufacturing/ supply of vaccines.
  • Direct/ prioritize workload activities of the process automation team, responsible for: Compliance with System Development Life Cycle (SDLC), GMP, safety and environmental regulations.
  • Collaboration with other functions within the Integrated Process Team through ownership of automated systems and Subject Matter Expertise Support of manufacturing activities on the shop floor
  • Design and implementation of process control improvements/ corrective actions
  • Troubleshooting and resolution of automation issues/ events
  • Participation in deviation investigations
  • Administration of automated control systems, sustaining state of Permanent Inspection Readiness
  • Apply leadership skills and sensibilities to foster a high performing, collaborative team environment
  • Serve as primary Subject Matter Expert and represent automation function on IPT leadership team.
  • Communicate daily with the business, technical and quality representatives through tier process
  • Support process automation inquiries during internal and external audits/ inspections and must therefore be able to speak knowledgeably about automation in association with the cGMP processes and manufacturing operations
  • Continuously evaluate automated systems and develop strategies to optimize and ensure quality/ stability of systems through future expansion, replacement, or upgrade.
  • Directly support site and global initiatives with respect to digital transformation and improving how West Point Digital Manufacturing Operations does business

Benefits

  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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