Sr. Manager CQV

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Function:

Supply Chain Engineering

Job Sub Function:

Project Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description:

Johnson & Johnson is seeking a highly skilled Sr. Manager CQV in the Commissioning & Qualification field. This position will be located in Geel  - Belgium.

In this role as Sr Manager, Commissioning & Qualification, you will have the exceptional opportunity to lead the CQV activities in large capital projects, from Strategy to Business Readiness, including aspects of project planning, training, resource management, execution logistics, close-out, document management, VTOP/TOTP handover and application of lessons learned.

This role is responsible for ensuring compliance with all applicable regulatory, J&J Quality standards and industry guidelines in Capital Projects.

A suitable candidate for this role will have strong working relationships with partners (project delivery, quality, operation, system owner and tech. transfer) to ensure high quality results meeting cGMP and site quality requirements. Will also be a self-starter with strong interpersonal, organizational, and technical skills.

Key relationships include working closely with the regional Local teams of the different business segments, E&PS Project Delivery Teams, Project Controls, Engineering & Design, and the CoE within the strategic project delivery group.

Key Responsibilities:

• Collaborate with Project Delivery team to deliver CQV activities in alignment to project goals

• Drive the adoption of Risk Based Qualification in capital projects

• Drive the adoption of E2E CQV Digital validation in capital projects using Kneat

• Ensure alignment with J&J standards along with engineering methodologies and guidelines.

• Provide recommendations to the overall Project Execution Plan to ensure CQV is accurately defined in alignment with E&PS practices

• Setup of a project CQV strategy and detailed plan

• Ensure automation/process control strategy is aligned with the overall CQV strategy

• Support project handover strategy to the end users.

• Supports project, in effectively scheduling, coordinating, mentoring and reviewing project activities with appropriate functional groups

• Lead the development of proposed CQV schedule and start-up sequence (dependencies of systems), and resource loading

• Drive effective and efficient execution of CQV program to deliver quality project outcomes meeting performance expectations.

• Supervise and evaluate CQV contractor safety performance throughout the duration of the project

• Lead project stage gate reviews for CQV to ensure strategy is being implemented accurately and improvements are identified

• Support and advice on set up of project organizational change program

• Support Engineering Document Control process and VTOP/TTOP handover

Education:

• A minimum of a Technical Bachelor's or equivalent degree in Engineering is required, Master's degree preferred

Experience

Required:

• Minimum of seven (7) years of relevant business experience in Commissioning and Qualification, Engineering or Quality

• Knowledge of regulatory requirements relevant to Commissioning and Qualification

• Experience in leading groups of internal and external team members

• Excellent problem solving and troubleshooting abilities

·         Excellent written and verbal c