Be an early applicantLess than 25 applicants

Company

Original Job Post

Bausch + Lomb · 2 days ago

Engineering Validation Specialist

Tampa, FL

Full-time

Onsite

Entry Level

1+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Health CareHealth Diagnostics

Actively Hiring

Insider Connection @Bausch + Lomb

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Develop sound scientific rationale/strategy for Qualification/ Validation of new or modified cGMP equipment, facilities, computerized systems, temperature-controlled areas / equipment, utilities and/or sterilization processes, as applicable.

Write and execute protocols to qualify/validate any of the above validation elements following the latest cGMP regulations.

Assess and perform timely process/equipment/systems re-qualifications and/or revalidations.

Evaluate test data and write final reports to summarize testing performed.

Communicate project requirements, scheduling, and results to ensure successful turnover of validated equipment or systems.

Participate in continuous improvement projects related to validation programs and procedures.

Review change control documents, work orders, and document change requests for assessing impact on validated systems.

Obtain and maintain access to the Aseptic Core Area.

Work in a flexible and fluid sterile, non-sterile, controlled working environment.

Responsible for exhibiting professional behavior with internal/external business associates.

Ensure validation activities meet FDA, EU, and ISO requirements.

Perform all other tasks, projects, and duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ValidationFacilitiesManufacturing equipmentCompoundingFillingPackagingSterilization processesMoist heatDry heatGammaEthylene oxideMedia fillsTemperature-controlled area/equipmentComputerized systemsCGMP regulationsValidation guidelinesHandling multiple prioritiesWorking extended/odd hoursEnglish language proficiencyMath skillsOrganizationalAnalyticalCommunicationLogical/mechanical aptitude

Required

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

Minimum 1-3 years of Engineering or Validation experience.

Experience in any of 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 and Computerized systems.

Organizational, analytical, computer, writing and communication skills.

Excellent logical/mechanical aptitude desired.

Knowledge of basic cGMP regulations and latest validation guidelines.

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

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

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

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