Sr. Manager CQV
Role details
Job location
Tech stack
Job description
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., 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
Requirements
A minimum of a Technical Bachelor's or equivalent degree in Engineering is required, Master's degree preferred, 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 communication skills (in English)
Excellent written and verbal communication skills (in German)
Preferred:
Global experience is beneficial, Agile Decision Making, Budget Management, Collaborating, Consulting, Cross-Functional Collaboration, Customer Centricity, Developing Others, Lean Supply Chain Management, Organizational Project Management, Project Engineering, Quality Assurance (QA), Regulatory Compliance, Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Strategic Supply Chain Management, Tactical Planning, Technical Credibility
