Job Details

  • Title: Verification Lead
  • Code: RCI-19314-1
  • Location: Sanford North Carolina (NC) 27330
  • Posted Date: 07/30/2020
  • Duration: 12 Months
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  Job Description

  • This job description applies initially to the capital project to create a new commercial Gene Therapy facility within a company US site.
  • This is a key leadership role within the project organization, along with the process and automation leads in the technical team.
  • The successful candidate will be responsible for all aspects of Commissioning / Verification for the GTx Stage 2 Project, from generation of Requirements Documents and support of the design phase, through to Verification completion and handover for full GMP Demo Batch manufacture.
  • Ability to effectively communicate, interact and collaborate with team members and external stakeholders is essential.
  • Management of Commission and Verification (C&V) activities on the project utilizing company’s Verification (ASTM E2500) model.
  • Ensure company best practices are imbedded in the execution approach for the C&V phase of the Project.
  • Design – Support the Engineering design
  • Generation of Requirements Documents in support of overall Design schedule.
  • Oversight of VQS generation.
  • Provide support to discipline design leads.
  • Establish and manage the day to day activities of Commissioning and Verification teams incorporating: Commissioning Engineers , Integrated Operations SMEs , Automation Compliance and Support,Construction contractor disciplines support.
  • Project Document Control
  • Develop document generation and field execution schedule that will minimize resource cost, integrate with design & construction schedules to maximise system turnover efficiency in support of the overall project schedule and facility start-up requirements.
  • Support generation of Inspection and Test plan for Equipment, including approach to integrated FATs (iFATs) and leveraging of testing.
  • Generate Commissioning &Verification test protocols.
  • Execute Commissioning and Verification o Integrate Technical Services activities during the C&V Phase including, engineering run protocols, Column Packing Trials and Mixing Studies. o Coordinate with the Operations Lead to support execution of Water Batches.
  • Handover to Technical Services and Operations in a fully functioning GMP state for execution of Engineering Batches.
  • Schedule - Responsible for building, tracking, and managing the schedule for C&V Phase through to Engineering Batch commencement.
  • Work with the Construction Manager to appropriately sequence the turnover of systems to commence commissioning activities, including coordination of the close out of punch list items.
  • Pharma experience is mandatory!
  • ASTM 2500 tag mandatory
  • Engineering Degree (bachelors or above) mandatory
  • Direct people leadership experience mandatory
  • Will manage a verification team of 3-5 members comprised of both colleagues and contract staff.
  • Also responsible for managing the partner verification firm.
  • Full time located at the Engineering Firm’s office (Eastern United States) during design phase, followed by full time location in Sanford during the construction and startup phase.
  • Travel of 25-50% possible to visit suppliers, fabricators, best practice meetings.
  • Min qualification – Degree in Electrical/Electronic or Chemical Engineering, or related field with substantial experience in this field.
  • Held a similar position on a large capital project.
  • Minimum (15 years) biopharmaceutical engineering project experience.
  • Knowledge of the Mammalian Cell Culture and Purification Processes or knowledge of Vaccines Manufacturing Processes.
  • Good understanding of risk management methodologies, with a proven ability to apply to Bio-pharmaceutical operations.
  • Knowledge of project execution for fully automated facility design (Delta V and Schneider control systems)
  • Experience in new facility start-up
  • Experience of managing capital budgets and resources.
  • Experience of large scale equipment package vendor management and FAT execution and coordination
  • Excellent interpersonal and communication skills.