CQV Engineer

Our client, a global leader in the Pharmaceutical and Medical Device industries, has been at the forefront of innovation since 1998, with operations in over 40 locations and a team of more than 2,000 employees across Europe, Asia, and the Americas. We are seeking a skilled (Commissioning/Qualification/Validation) CQV Engineer to support a range of high-impact projects within North America.

Key Responsibilities

As a Validation Engineer, you will:

Lead Validation Efforts: Oversee the Front End Planning (FEP) for validation deliverables on capital projects, with budgets up to $250 million.

Collaborate on Design Phases:Work closely with stakeholders, Subject Matter Experts, and vendors to create essential validation documentation, including:

Project Validation Plan (PVP)

System Impact Assessment (SIA)

User Requirements Specifications (URS)

Functional Requirement Specifications (FRS)

Design Specifications (DS)

Risk Assessments, such as Failure Mode and Effects Analysis (FMEA)

Define Validation Strategies: Establish effective validation schedules, risk management plans, and strategies in collaboration with Corporate Engineering, Division Quality Assurance, and Site Operations.

Manage Validation Plans: Develop and execute comprehensive validation plans, working with cross-functional project teams to ensure scope, cost, and schedule controls are maintained.

Provide Support for Project Controls: Monitor and report on the validation scope, managing any issues and creating compliant solutions.

Assist with Contingency Planning: Develop and implement plans to address project schedule delays and financial challenges.

Document and Execute: Support document execution, including Factory Acceptance Tests (FATs) at vendor sites, and provide onsite support during Annual Plant Maintenance (APM).

Track and Report Hours: Accurately record and report project hours through weekly timesheets.

Demonstrated experience in validation engineering within Pharmaceutical or Medical Device industries.

Strong understanding of validation documentation, project management, and risk assessment.

Excellent communication and collaboration skills, with the ability to work effectively across departments and with external vendors.