Job Information
Bausch + Lomb Senior Validation Engineer in Tampa, Florida
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company 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. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Objectives/Purpose of job:
This position will perform and support the validation of manufacturing/ packaging equipment, facilities, utilities, computerized systems, temperature-controlled areas/equipment, Media Fills, and sterilization processes associated with the manufacture of pharmaceutical products to assure compliance with cGMP’s, Regulatory, QBD/QRM and BLP’s guidelines.
Responsible for ensuring functional areas, projects, and/or systems are in compliance with Computer System Validation (CSV) and Data Integrity standards and other validation regulatory requirements. The role will provide independent compliance oversight as a validation compliance lead for the systems installed at the site. Job assignments are to be completed with minimal supervision.
Position will provide coaching and mentoring to other engineers based on experience and implementation of QBD/QRM validation approach. Assume the responsibility for the cGMPs and Environmental Health and Safety procedure awareness, and compliance within the respective area.
Key Activities/Responsibilities:
Develops sound scientific rationale/strategy for qualification/validation of new or modified cGMP equipment, facilities, computerized systems, temperature-controlled Areas / Equipment, Media Fill, Air Parallelism studies, utilities and sterilization processes, as applicable.
Design, implement and execute protocols to qualify/validate cGMP equipment, facilities, computerized systems, temperature-controlled areas / equipment, aseptic processes, utilities and sterilization processes in a manufacturing environment following the latest cGMP regulations and QBD/QRM principles.
Participate with and oversee a team of Validation Engineers to complete Validation Activities.
Assess and oversee timely process/equipment/systems requalification’s and/or revalidations to confirm and provide evidence that such process/equipment/systems remain in a validated state.
Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.
Coach and mentor less experienced engineers on validation methodology and processes.
Perform project management duties for limited number of CIP/ compliance related projects.
Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.
Identify and participate in continuous improvement projects related to validation programs and procedures.
Interface with cross functional teams such as Engineering, Planning, Project Managers, Quality representing validation to help determine impact to validated state and validation strategy for new or modified equipment/ systems/facilities.
Assist with regulatory audits/inspections.
Review change control documents, work orders, document change requests for assessing impact on validated systems.
Open to a flexible and fluid sterile and controlled working environment.
Must be able to gown as appropriate per company procedures for aseptic areas environment.
Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Has experience with implementing/utilizing QBD/QRM approach to validation.
Perform all other tasks, projects, and duties as assigned
Qualifications and Training:
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.
This position will be a site-based role and not a remote job.
Must be able to read, write, and speak English and possess basic math skills.
This position may be available in the following location(s): [[location_obj]]
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .
Our Benefit Programs: https://www.bausch.com/careers/benefits/
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.