Validation Engineer II

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:

Validation/qualification of manufacturing equipment, facilities, utilities and computerized systems associated with the manufacture of pharmaceutical or medical devices to assure compliance with cGMP’s, FDA’s and BLP’s guidelines.  Job assignments are to be completed without a considerable amount of supervision or coaching.  Assume the responsibility for the GMP and Environmental Health and Safety procedure awareness, and compliance within the respective area.

Key Activities/Responsibilities:

• Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
• Design, implement and execute protocols to validate manufacturing equipment, facilities, utilities in a manufacturing environment following the latest cGMP regulations.
• Assess and perform process/equipment/systems requalification’s to confirm and provide evidence that such 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.
• 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 efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.
• Ability to run projects and coordinate personnel. 
• All other duties as assigned. 

Qualifications/Training:

• Experience in one or all of the following types of validation desired: Utilities, facilities, manufacturing process equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, and ethylene oxide.
• Computerized systems/SQA experience is a plus.
• Strong Project Management, 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.
• Able to work extended/odd hours around manufacturing schedule required.
• Must be able to read, write, and speak English and possess basic math skills.

Education:

⦁    Bachelor's Degree in Engineering or any Science Disciplined degree.  Minimum 3 years of Engineering or Validation experience.  

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.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

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.

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