Qualification Engineer

We are seeking an experienced CQV Engineer to support technical projects within a highly regulated pharmaceutical manufacturing environment. Reporting to the Senior Manager Validation & Compliance within the Site Engineering organization, you will play a key role in the commissioning, qualification, and validation of secondary packaging systems and associated computerized systems.

The successful candidate will bring hands‑on CQV expertise and be responsible for developing, implementing, executing, and reporting validation strategies that ensure technical solutions meet internal customer requirements, GMP expectations, and company procedures. You will drive the development of commissioning, qualification, and validation documentation while providing technical guidance throughout project execution.

Key Responsibilities

Develop, review, and maintain validation lifecycle documentation, including:

System Criticality Assessments

Test Protocols

Requirements Traceability Matrices (RTMs)

Commissioning, Qualification & Validation Summary Reports

Ensure all documentation is compliant with GMP requirements, internal procedures, and project objectives.

Support validation planning activities throughout the project lifecycle.

Lead and execute commissioning, qualification, and validation activities for manufacturing and packaging systems.

Develop and implement test strategies to verify that systems perform according to defined requirements.

Coordinate protocol execution, test witnessing, deviation management, and final reporting activities.

Ensure timely completion of CQV deliverables in accordance with project schedules.

Technical Support & Project Collaboration

Provide validation and compliance guidance to project teams throughout design, implementation, testing, commissioning, and qualification phases.

Ensure technical solutions are implemented in alignment with approved validation strategies and internal SOPs.

Collaborate with Engineering, Manufacturing, Quality, Automation, and external vendors to ensure successful project delivery.

Identify, assess, and elevate project risks or compliance concerns where necessary.

Additional Responsibilities

Support continuous improvement initiatives within Validation & Compliance.

Undertake additional tasks and projects as assigned by management.

Basic Qualifications

Minimum 3 years of experience executing Commissioning, Qualification, and Validation activities within the pharmaceutical or biotechnology industry.

Hands‑on experience with Secondary Packaging Systems.

Experience with Print & Inspection Systems such as Systech, Cognex, or equivalent technologies.

Experience with Computerized Systems Validation (CSV).

Demonstrated commissioning and qualification experience within secondary packaging operations.

Strong understanding of validation lifecycle principles and document interdependencies.

Preferred Qualifications

Ability to work independently with minimal supervision, including within remote project teams.

Strong technical writing and documentation skills.

Excellent verbal and written communication skills.

Effective stakeholder and customer relationship management capabilities.

Strong critical thinking and problem‑solving skills.

Ability to establish priorities and proactively manage project deliverables and timelines.

Working knowledge of GMP regulations, validation standards, and pharmaceutical compliance requirements.

Experience supporting project phases including design, development, implementation, testing, commissioning, qualification, and validation.

Ability to anticipate, evaluate, and resolve multiple simultaneous project challenges by combining technical expertise with business awareness.

Computerized Systems Validation (CSV)

Secondary Packaging Equipment

Print & Vision Inspection Systems

GMP Compliance

Technical Documentation

Stakeholder Management

Problem Solving & Critical Thinking

Cross‑functional Collaboration

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