Validation Engineer

Key Responsibilities:

Serve as a Subject Matter Expert (SME) for Quality Control, Manufacturing, and other departments in the design, operation, and troubleshooting of analytical equipment.

Lead and execute validation plans for analytical system updates and process improvements.

Conduct and document Installation Qualifications (IQ), Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as required.

Manage validation-related records such as Change Controls (CC), CAPAs, and Deviations using TrackWise.

Develop documentation including User Requirement Specifications, Data Integrity Risk Assessments, and Audit Trail Risk Assessments.

Review equipment manuals and develop comprehensive validation strategies.

Oversee procurement of analytical equipment, ensuring specifications, quotations, budget alignment, and proper installation.

Maintain ownership of analytical equipment throughout its lifecycle.

Identify and resolve quality issues, engaging key stakeholders as needed.

Participate in risk assessments and support commissioning/qualification document reviews and approvals.

Perform other duties as assigned.

Required Skills and Qualifications:

In-depth technical knowledge of Quality Control and manufacturing processes.

Hands-on experience with Quality Systems (e.g., deviations, CAPAs, change controls) and TrackWise.

Strong understanding of validation processes across equipment, cleaning, computer systems, and manufacturing.

Proven ability to manage medium-to-large scale projects within defined timelines.

Excellent organizational and planning skills with sound decision-making capabilities.

Collaborative mindset with strong interpersonal skills and cross-departmental experience.

Role model in GMP and safety compliance.

Strong verbal and written communication skills.

Proficient in MS Project, Word, Excel, and PowerPoint.