Commissioning & Qualification Lead

Carolina, Puerto Rico
Contracted
Sharetech Technical Group
Experienced

We are seeking a  C & Q Technical Lead that will be  responsible for planning, preparation, coordination and leading a CQ team from documentation preparation through Design, FAT, CM oversight, MC, integrated CQ execution and successful handover to the Client USER team.
The scope of CQV activities relates to Process and Process Support Equipment. The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider.
Aside to delivering in line with the Client C+Q requirements, the CQ Lead will ensure that overall Budget, Baseline Schedule, Compliance, Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings, providing guidance on CQ matters and representing PDP in terms or contractual obligations.
General Management and Coordination in conjunction with the Client and project Team:
· Development of an overall level 3 CQ plan in conjunction with the Client project scheduler
· Meeting and delivering key project milestones
· Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings
· Org chart maintenance and resourcing
· Approval and tracking of holidays
· HSE and Safe Start-Up including LOTO
· CQV Doc Preparation
· CQV Execution Readiness
· CQV Execution
· P+ID Walk down and Punch item Categorization
· Deviation Management & Change Control (Process and Automation)
· Punch List Management
· Vendor Management
· Developing and Reviewing CQ test plans and specifications prior to their approvals
· Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs)
· Management and Filing of CQV related documentation
· Management and Coordination of CQ execution activities, including:
· System and Area Handover
Main responsibilities and tasks relating to CQV documentation include but are not limited to:
· Setting up the Doc Prep team
· Ensure coordination meeting are in place
· Defining workflows and approval cycles for CQ test plans and specifications
· Coordinating development and approvals with the Client lead, Construction QA lead, and with other disciplines including Vendors, Automation, Eng, and USER etc.
· Developing positive working relationship with team members and USER groups
· Ensuring adherence to schedule, manhours and quality
· Support Prep team as required
Execution Readiness:
· FAT support where requested
· Documented training on PSPs
· CQ Team development and resource and allocation
· Monitoring and coordinate MC readiness
· CQV documentation readiness
· Monitoring and coordinate Automation readiness
· Meeting with Subcontracts
· Calibration readiness including test equipment and resourcing
· HSE Plans, EHS System qualifications and LOTO device readiness during CQ activities
· Vendor notification of SAT dates per CQ Schedule
· Materials, consumables, spares, first fill available in stores
· Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution
CQV Execution:
· Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
· HSE management in conjunction with HSE Lead
· Manage CQV execution activities in conjunction with area CQV Lead
· Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, and SAT)
· Tracking of changes, punch items and deficiencies
· Reviewing first of type CQV test reports prior to their approvals
· Assisting system leads/engineers with system handover to production
· PQ and PPQ support where necessary
Project Controls:
· Planning & Scheduling
· Development of an overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving;
· System Definition
· System Classification
· CQ strategy definition with CM and A/E firm
· Handover alignment with USER
· Fortnightly updates to CQ schedule including actualized and forecasting data for Doc pre and Execution Phases
· Liaise with PMO and USER with inputs to PQ and PPQ schedule
· Progress Reporting
· Development of a monthly project report including but not limited to:
· Contracts
· Develop scope of work(s) for CQV related vendors and contractors
· Approval of invoices based on progress and or timesheets
· Progress measurement
· Invoice approval and stage payment
· Cost
· Manage overall cost on behalf of PDP/Client for CQV activates (Directs and Indirects)
· Scope including schedule delay management and related change control
· Man-hour and cost management
Key Performance Indicators
· Strong knowledge and experience of Process Commissioning and Qualification.
· Management: Compliance with a schedule at a system and area level with the planned resource levels.
· Feedback from customer (i.e. Quality, HSE, operations)
· Safety: No lost time accident
· Quality: well-executed testing with minimum rework and re-execution.
· Quality: all deviations resolved to Client satisfaction and handover completed for all systems.
Qualifications:
· Experience in Process Commissioning and Qualification.
· Languages: English - fluent in speaking and writing.
· Experience: Minimum 10 yrs.
·Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.


Availability to Travel/Expected Travel:  Will vary during project cycle. Minimum travel required during early phases

You must be able to reside  within commuting distance  to site since relocation packages is not available.


 

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

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