Toronto, Ontario

CQV Technical Lead / Project Lead

CQV Technical Lead / Project Lead
Toronto, ON
We are looking to recruit a CQV Technical Leader (Technical Manager) with a significant technical background, and strong CQV Technical Project Management/ Leadership skills and experience.
In this role, you will lead a team of 15-20 Commissioning, Qualification & Validation (CQV) Engineers at a large Pharma manufacturing facility.
Who we are:
ALTEN PROEX is a leading global engineering and IT consulting services firm that supports the development strategy of its customers in the fields of innovation, R&D and technological information systems. With 34,000 highly qualified engineers globally, in more than 20 countries, including more than 2000 Life Sciences Engineers in 15 countries, ALTEN provides end to end services in the Life Sciences Sector with activities including Manufacturing (Quality Assurance, Reliability, Automation, Validation, CSV), Design of Medical Devices (classes I to III), Regulatory Affairs and Business Transformation and digital services.
The CQV Technical Leader will manage CQV Documentation and Execution activities and be responsible for project planning, project management, project delivery.
To qualify, you should have:
Degree in engineering (preferably) or life sciences or suitable industry experience
10-12+ years’ hands-on/field experience in commissioning and qualification of pharmaceutical facilities
Demonstrated experience in technical leadership, project management, coordinating or project activities.
Experience providing technical leadership and project management of CQV activities, including CQV documentation, execution and project delivery
Experience tracking and review the performance progress of CQV project
CQV project resources management
Experienced on training and mentoring junior staff members
Direct and organize the weekly activities of other Senior CQV Engineers
Experience managing continuous improvement of the C&Q activities in line with current guidelines and standards
Experience providing Review/Approval of Validation and Commissioning Master Plan, high level project strategy, procedures, commissioning and qualification protocols (SAT/commissioning, IQ and OQ)
Investigating and providing resolution of technical issues during Commissioning and Qualification phase
Review and follow-up the technical documentation from the early design phases in order to align it with GMP and C&Q requirements
A track record to demonstrate that site project execution is undertaken in compliance with client procedures and safety standards
Demonstrated ability to work in a fast-paced environment.
Strong interpersonal skills.
Excellent problem solving and troubleshooting abilities.
High level of familiarity with Excel, Word, and Microsoft Project, required.
Proven organizational, time management, and project management skills.
In addition, the CQV Technical Lead must have excellent oral and written communication skills and experience in the management of the CQV project activities including the formal Systems Hand-over to the Client in line with contractual terms and obligations
The CQV Technical Lead must also have excellent Stakeholder relationship management skills, reporting skills, and experience in leading steering committee’s




Our Advisor for this position

Heather MacKenzie

Talent Acquisition Manager

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