Role Automation C&Q Lead
Reporting to Client Automation/Project Manager
Location: Indianapolis IN
Duration: 6 Months
Roles & Responsibilities:
Responsible for the C&Q leading and managing for Pharma or Biopharma clients for various PCS including DCS system (Emerson Delta) PLCs BMS Historian MES F&G CCTV Access control etc
Oversee and coordinate automation commissioning qualification and validation (CQV) deliverables to ensure compliance with project specifications and regulatory requirements.
Review and approve CQV documentation including protocols and reports ensuring they meet industry standards
Responsible for C&Q for OT network architecture networking and hardware deployment in Clean room environment for Pharma and Bio Pharma.
Liaising directly with the vendor in terms of status of orders and delivery of PCS equipments
Coordinating with multidisciplinary teams including Process Manufacturing Quality for planning and scheduling
Leading and supporting on NC Change controls and CAPA.
Continuous improvement of the system and support for Operations.
Able to work with Process Operations Technology Development and Quality team for driving and delivering automation project
Project Management:
Create and maintain project schedules using appropriate tools
Planning daily/ weekly Activities assigning resources and Tracking Progress
Track project progress and identify potential roadblocks.
Provide weekly status reports to stakeholders.
Manage project risks and issues scope and resources
Coordinate with various Automation vendors for their scope of vendors and resources
Collaborate with crossfunctional teams to ensure successful integration.
Team Leadership:
Manage a team of Automation Engineers and consultants of size 20 Engineers
Assign tasks and responsibilities based on team member skills and availability.
Provide guidance and mentorship to team members
Ensure team members are following standard work processes.
Requirements:
Minimum of 10 years experience in a similar role ideally in the pharmaceutical industry.
Experience in the Designing and commissioning of DeltaV DCS project for GMP manufacturing site.
Through understanding of Batch S88 standards (CM EM Phases Recipes Units etc)
Thorough understanding of OT Networking and Virtualization in OT environment for Pharma and Bio Pharma.
Experience leading and managing Engineers and Senior Engineers.
Understanding of Pharmaceutical or Biopharmaceutical process
Expert in of automation hardware and networking technologies
Emerson DeltaV DCS Batch experience required
Expert with SDLC and quality management processes in the pharma
Ability to work well in a team environment.
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