Specialist, Engineering

Overview

The West Point Technical Operations organization is seeking a highly motivated individual for a Specialist – Engineering position within the Building 12 Varicella Bulk team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance and anticipating customer needs to identify and implement solutions. The Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture.

In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Operations, Quality, Automation, Maintenance and others. This role is specifically focused on process data analytics.

Additional responsibilities include:

• Provides technical support for Varicella bulk manufacturing at our West Point site to align with department, site, and franchise objectives.
• Provides on-the-floor support for complex operational and technical (process/equipment) issues.
• Owns, maintains and continuously improves data analytics and data visualization tools to support robust proactive process analytics (PPA).
• Provides ad-hoc data analysis to support IPT priorities.
• Owns and leads the PPA Tier process.
• Engaged with data analytics centers of excellence and supports the development of data literacy within the organization.
• Leads or works as a team member on projects to improve the performance of our processes, including complex investigations, corrective/preventative actions (CAPAs) and equipment validation/qualification.
• Develops and authors technical and manufacturing documents for investigations, process design/definition/qualification/validation, change control, annual product reviews, standard operating procedures (SOPs), batch records, and preventative maintenance.
• Monitors the health of the process through continuous process monitoring, communicating observations proactively to stakeholders.
• Prepare documentation to support regulatory submission and participate in regulatory inspection activities for the facility.
• Aplies a continuous learning mindset to maintain a high level of technical process and system knowledge, enabling success with core responsibilities.
• Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans.
• Assures consistent application of standardized work, engineering and process tools.
• Promotes open communications and teamwork. Effectively collaborates with cross-functional peers.
• Supports safety, environmental, and compliance initiatives.
• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.

• B.S. degree in Engineering or Sciences.
• Minimum 2 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations

• Strong problem-solving skills.
• Developed communication, leadership and teamwork skills.
• Ability to manage projects/work to ensure timely completion.

• Experience with multiple data management tools (e.g. Spotfire, Power
  
  BI, Dataiku, Seeq, Datalynx, MANTIS, PI Systems, JMP)
• Familiarity with different statistical analysis methods
• Experience in biologics, vaccine or bulk sterile manufacturing facilities.
• Understanding of sterile and aseptic processing #Vet Jobs #EBRG

Adaptability, Change Control Management, Data Analysis, Data Literacy, Documentation Compliance, Engineering Processes, Equipment Troubleshooting, Factory Operations, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Operations, Personal Initiative, Process Improvements, Process Optimization, Professional Integrity, Project Management, Root Cause Analysis (RCA), SAS JMP (Statistical Software), Technical Writing, Technology Transfer, Vaccine Manufacturing, Writing Technical Documents

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