Commissioning and Qualification Engineer

Jan 14, 2022

Job Description

What You'll be Doing:

Responsible for defining, planning, executing and reporting on Commissioning & Qualification for CAPEX projects and routine manufacturing operation ensuring GxP compliance of plant/facilities/equipment.

Strategy & Organizational Development:
• Support internal and external audits
• Create and maintain GOPs and provide standard training
• Implement GOPs
• If needed, create site SOPs & templates

Project Engineering & Control:
• Develop Project schedule
• Perform project risk assessment
• Identify technical solutions
• Prepare project quality plan
• Develop project document management and archiving concept
• Perform project reviews (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE)
• Develop project commissioning plan / strategy
• Establish project change management and manage changes
• Develop project execution plan (e.g. C&Q)
• Prepare / execute Project Health & Safety Risk Assessments (Equipment / Process)
• Expedite and manage project vendors / contractors / 3rd parties in project
• Develop test specification / plan for commissioning & qualification in projects
• Perform new equipment FAT / SAT / inspections in project
• Implement and monitor construction contractor safety and inspection plan
• Execute work orders for projects as per method statement
• Perform commissioning activities
• Manage project deficiencies and deviations
• Perform provisional and final project handover

(Re-) Qualification:
• Develop qualification plan
• Perform GMP risk assessments (incl. Sensors SRA)
• Create DQ, IQ and OQ protocols
• Execute DQ, IQ and OQ
• Create DQ, IQ and OQ reports
• Provide technical trouble shooting during PQ and validation
• Develop periodic requalification plan
• Execute periodic requalification plan

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What You'll Bring to the Role:

Education (minimum/desirable):
Engineering Technician / Engineering Associate or equivalent.

• > 5 years of engineering project / commissioning / qualification / Compliance in Pharma
• Excellent technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects
• > 5 years of demonstrated leadership abilities, leading both internal and external team members
• Excellent interdisciplinary knowledge (process, HVAC, automation, etc.)
• Outstanding GxP and regulatory knowledge
• Advanced HSE knowledge
Global Drug Development
Fort Worth, TX
Technical Operations
Full Time
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Commissioning and Qualification Engineer

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