Full-Time

Associate Specialist

Manufacturing Automation

Posted on 10/25/2024

MSD

MSD

Junior, Mid

No H1B Sponsorship

North Wales, PA, USA

Hybrid work model requires three days in-office per week.

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor’s degree in an Engineering, Science, Information Technology, or related field
  • Associate's degree in an Engineering, Science, Information Technology, or related field with 2 years of experience in process automation or equivalent.
  • High School diploma with 5 years of experience in process automation or equivalent.
  • Highly developed communication, teamwork skills.
Responsibilities
  • Provide technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, Automation Installation/Operational qualification.
  • Partner with cross-functional team to develop automated processes and complete successful qualification of equipment/process.
  • Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility.
  • Author and update technical documents necessary for automated process design, definition, and qualification.
  • Maintain automation systems in compliance with cGMPs.
  • Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion.
  • Responsibilities include troubleshooting issues, identifying trends, process monitoring, system administration, update documentation, querying data, operator training and participating in deviation investigations.
  • Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
  • Communicate daily with the business, technical, and quality representatives within the area of support through the tier process.
  • Support process improvement projects and complex manufacturing investigations.
  • Support digital and data integrity initiatives for the project.
  • Provide technical support to manufacturing for complex problems and issues.
  • Develop and assure consistent application of standardized work, engineering, and process tools.
  • Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Develop and manage automation systems standard operating procedures, work instructions.
  • Responsible for assigned systems alarm and responses and reconciliations.
  • Support regulatory submission preparation and inspections for the facility.

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A

INACTIVE