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Company

Original Job Post

Bausch + Lomb · 3 days ago

Senior Validation Engineer

Tampa, FL

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Develop scientific rationale/strategy for equipment and systems qualification/validation.

Design, implement, and execute protocols for qualifying/validating equipment and systems.

Oversee a team of Validation Engineers and ensure timely requalification/revalidation processes.

Evaluate test data, write final reports, and gather necessary documentation.

Coach and mentor junior engineers on validation methodology.

Manage compliance-related projects and communicate project requirements and results.

Identify and participate in continuous improvement projects related to validation programs.

Interface with cross-functional teams and assist with regulatory audits/inspections.

Review change control documents and assess impact on validated systems.

Work in sterile environments, gown as required, and support multi-shift operations.

Exhibit professional behavior and follow company policies and practices.

Perform other tasks and duties as assigned.

Qualification

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ValidationManufacturing equipmentSterilization processesMedia fillsTemperature-controlled area/equipmentComputerized systemsSQA aseptic processingCGMP regulationsValidation guidelinesQBD/QRM approachEnglish language proficiencyMath skillsProblem-solvingOrganizationalAnalyticalCommunicationLogicalMechanicalAble to handle multiple priorities

Required

Bachelor's Degree in Engineering or any Science Disciplined degree.

Minimum 7-10 years of Engineering or Validation experience.

Experience in the following types of validation is desired: Utilities, facilities, manufacturing equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, and ethylene oxide; Media Fills, temperature-controlled area/equipment.

Computerized systems/SQA experience is a plus.

Organizational, analytical, computer, writing and communication skills.

Knowledge of aseptic processing highly desired.

Excellent logical/mechanical aptitude desired.

Knowledge of cGMP regulations and latest validation guidelines.

Able to handle multiple priorities in a fast-paced environment.

Experience with implementing/utilizing QBD/QRM approach to validation.

Able to work extended/odd hours around manufacturing schedule required.

Must be able to read, write, and speak English and possess basic math skills.

This position will be a site-based role and not a remote job.

Benefits

Health Insurance

Company

Bausch + Lomb

Glassdoor

3.6

We're a leading global eye health organization that is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life.

Founded in 1853

Rochester, New York, USA

10,001+ employees