Automation Engineer

1 day ago

Hopewell, United States Verista Full time

At Verista, we're committed to empowering growth and innovation within the scientific community. Our team of experts collaborates with the world's most recognizable brands in the life science industry to solve complex business needs.

The nature of our business is to provide innovative solutions and services that empower informed decision-making. Our significant investment in our people and capabilities enables us to deliver high-quality results.

We're seeking a highly skilled Principal Automation Engineer to join our team. As a key member of our automation team, you will be responsible for performing GMP/GLP activities, SCADA, BAS, Maximo, and other automation engineering systems administration.

Key Responsibilities:

  • Perform GMP/GLP activities
  • SCADA, BAS, Maximo, and other automation engineering systems administration
  • Monitoring of system performance and operability
  • Develop appropriate Change Controls to enhance systems and operation
  • System Modifications per Change Control
  • Develop appropriate Validation Protocols, Reports, and Life-Cycle documents
  • Execution of Validation Protocols
  • Automation Systems Management
  • Develop appropriate automation for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments
  • Author appropriate Change Controls and Test Scripts and serve as Manufacturing's Subject Matter Expert for applicable changes
  • Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT)
  • Ability to prioritize and juggle multiple concurrent projects and day-to-day requests
  • Liaison with Business, Managed Services, and IT to coordinate the IT Change Request processes
  • Maintain current knowledge base of solutions and work with Managed Services sustainment teams to facilitate technical break / fixes

Requirements:

  • Candidate must be local to Hopewell, NJ
  • Knowledge of domestic / international regulatory guidelines / compendia, (FDA, ICH, USP and EMEA guidelines) for validation of equipment and systems
  • Knowledge of applicable cGMP/GLP requirements, procedures, methods, and protocols for performance of assigned duties & responsibilities

Training:

  • cGMP training
  • Applicable Corporate and Departmental Directives, Policies, and Procedures
  • Good Manufacturing Practices and Good Documentation Practices
  • QA Quality General
  • Hopewell Biologics Manufacturing General/All
  • HBM Automation Control and Data Acquisition
  • Engineering EHS Training
  • Lab/Biological Safety EHS Training
  • Hopewell Biologics Manufacturing Gowning

Education:

  • Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least six years of related experience that provides direct scientific knowledge of system automation validation principles and biologics production equipment/systems

Expertise:

  • Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, Cleaning Validation, SCADA system architecture, Biotech Process Equipment/Systems
  • Proficient in use of electronic systems- Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS)
  • Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA Systems
  • Familiarity with OSI Pi a plus

Benefits:

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

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