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Lead CQV Automation Engineer

  1. East Coast
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
21-11-2023
32699
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Lead CQV Automation Engineer - Raleigh - 12-month contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented Lead CQV Automation Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Responsibilities: 
  • Lead CSV CQV Engineer for review and/or approval of all Automation CSV Master Plans, procedures, and other documents relevant to CQV scopes of work. This scope includes PAS, BMS, EMS, MES, Data Historian, OSI Pi and Equipment PLC systems. The Lead CSV CQV Engineer will be the single point of contact to the Automation CSV team and will participate in weekly meetings to ensure the CSV strategy and approach are aligned with CQV expectations and requirements. The Lead CSV CQV Engineer will be the eyes and ears for the CQV Team leads with respect to Automation Team deliverables thus ensuring seamless integration into the CQV strategy, schedule and test plans.
  • Liaise with and support the CQV Buildings, Support Equipment and Clean Utility Teams, as well as interface with and support CQV Set to Work for GMP and non-GMP equipment and systems. Liase with Automation PM in relation to CSV portion of Project Schedule to identify and enable automation testing at appropriate times to facilitate the efficient startup of system and equipment. Coordinate and assist CSV Group for Project from Design through to PPQ Stage.
  • Identify the scope and strategy for testing of all CQV efforts to be implemented for the Project, both GMP and Non-GMP Systems. Support the team leads during development of test plans which require automation software to operate. This includes helping to escalate prioritization of code development and commissioning to the Automation team in support of such testing. Identify prerequisites as necessary for the testing of code to be used in support of CQV testing and inform the CQV scheduler to ensure prerequisite logic is included in the schedule.
  • Aligning with Automation, reviewing Computer Systems Validation Master Project Plan for the Automation & IT computer Systems, PLAN- Validation Project Plan (VPP) for PAS and OEM Automation Computer Systems, PLAN- Validation Project Plan for OSI-Pi Site Historian and PLAN-Computerized
  • Systems Validation Project PLAN for Standalone QC laboratory instruments.
  • Support Automation Group in field execution and Final Report writing. Support the APCC (Automation Project Change Control). In tandem with Automation, responsible for generating any CQV Automation/CSV Kneat Test Templates.
  • Lead and/or support Risk Assessments sessions, representing CQV, including:Complexity/Customization, FMEA, Product Contact List (PCL) and Critical Instrument List (CIL).

Requirements: 
  • Minimum 10 year relevant experience on Large Scale Projects
  • CSV of both PLC and Delta-v systems, minimum 10 years
  • Experience with liaising with other departments and building PMs/leads
  • Minimum of 10 years of relevant experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Database, Access, EIDA, Spreadsheets, Word Processing, Visio, Microsoft Project)

Interested? Get in touch today!  

The candidate must have the rights to work in the location stated in the job advert.

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