Commissioning and Qualification Engineer

6 days ago


Charlotte, North Carolina, United States PACIV Full time
About the Role

PACIV, a leading control systems integration and regulatory compliance engineering firm, is seeking a skilled Validation Engineer to join our team in Indianapolis. As a key member of our team, you will play a crucial role in managing various commissioning, qualification, and validation facets within our clients' Biotechnology and Pharmaceutical sites.

Key Responsibilities
  • Commissioning and Qualification
    • Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation (CSV) planning documents through System Retirement.
  • Project Management
    • Actively participate among cross-functional teams and support project initiatives to ensure projects are delivered on time and to required quality standards.
  • Support Execution
    • Support execution of large product launches/releases, small capital projects, and process improvement changes related to the manufacturing and/or laboratory systems within the client site.
Requirements
  • Education
    • Bachelor's degree and/or Master's degree in Engineering or Technical discipline required.
  • Experience
    • 1 - 3 years of validation experience in the Pharmaceutical Industry.
  • Skills
    • Comfortable with a 24/7 manufacturing environment.
    • Works well with others within a team and takes accountability.
    • Can handle a high-pressure, high-stress work environment.
    • Result-driven and self-motivated.
    • Strong interpersonal and communication skills (verbal and presentation).
    • Organized with strong computer literacy such as MS Word, Project, Excel, etc.
Desired Hard Skill Sets
  • Validation Principles
    • Familiarity with Validation principles and executable deliverables (i.e. Requirements, Design, Testing, Reports, etc.).
  • CSV Experience
    • CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Records and Signatures.
  • Project Management
    • Project Management experience with the ability to lead and drive projects to completion autonomously.
Other Requirements
  • Location
    • Indianapolis.
  • Travel
    • Up to 25% of the time to various suppliers, collaborators, and client sites outside of Indianapolis.
Compensation
  • Benefits Package
    • Competitive Salary and Benefits Package, which includes:
    • Paid Time Off (PTO)
      • Paid Time Off (PTO) for vacation, sick, and company holidays.
    • Health Insurance
      • PACIV pays 90% of the premium for the health insurance plan.
    • Life Insurance
      • $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the team member's cost.
    • 401(k) Retirement Plan
      • 401(k) Retirement Plan with company match.
    • Project Performance Bonuses
      • Project Performance Bonuses (for qualified projects and employees).


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