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 the Job:This position will perform and/or support the qualification/validation of the following validation elements: 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, and BLP’s guidelines.Job assignments are to be completed with supervision of a Validation or Project Manager.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, 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 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.
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.
Participate in continuous improvement projects related to validation programs and procedures.
Review change control documents, work orders, document change requests for assessing impact on validated systems.
Obtain and maintain access to the Aseptic Core Area
Open to a flexible and fluid sterile, non-sterile, controlled working 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.
Ensure that validation activities meet the requirements of FDA (21 CFR 820 and 21 CFR 11), EU Annex 11, ISO13485:2016 and FDA Data Integrity requirements and any other.
Perform all other tasks, projects, and duties as assigned.
Qualifications/Training:
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.
Eligibility for Internal Applicants:
Have no corrective actions at the written warning level in last six months / no final warning level in the last 12 months / no active PIP.
Meet the qualifications of the position as stated above.
Be in your current job for 12 months.
Position applying for must be a step up in progression and not a step down.
This position may be available in the following location(s): [[locationobj]]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/Bauschjobpostingstatement.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.
