Validation Technician IV

Bausch & Lomb GmbH; Greenville, Northern (SC, KY); Hybrid; USD 52,000 - 76,000; Full time

Job summary

Bausch + Lomb in Greenville, SC seeks a Validation Technician to support the Site Validation Master Plan, performing re-qualifications and related validation activities.

The role requires collaboration with operations, microbiology, chemistry, metrology and maintenance to ensure GMP compliance and data integrity in all validation work.

Experience in pharma/medical devices and an Associate or BS in science is preferred; familiarity with Ellab data loggers is a plus.

Qualifications

• Associate Degree in Science preferred; BS desirable.
• 0-3 years in validation; 5 years in Pharma/Medical device industries with manufacturing or QC lab experience.
• GMP and Data Integrity knowledge; strong communication and interpersonal skills.

Responsibilities

• Lead validations for routine re-qualifications of steam sterilizers, line sterilization, heat sterilization, aseptic simulations.
• Re-qualifications require entry to aseptic areas and use of Ellab Datalogger or equivalent.
• Author validation strategies, protocols, execute validations, analyze data and write final reports.
• Conduct periodic reviews of validated equipment and systems per SVMP.
• Peer reviews of validation packages and provide feedback.
• Collaborate with operations, microbiology, chemistry, metrology and maintenance.

Skills

Self-Driven

Verbal and Written Communication

GMP and Data Integrity knowledge

Interpersonal skills

Results Oriented

Quality mindset

Education

Associate Degree in Science

Bachelor of Science

Tools

Ellab data logger

Job description

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 Technician will be responsible for supporting tasks outlined in the Site Validation Master Plan (SVMP).

Key Activities/Responsibilities:

Job Functions:

• Lead and coordinate validations for routine re-qualifications of steam sterilizers, line sterilization, heat sterilization, aseptic simulations (Media Fills), sterility isolators that support the SVMP, among others.
• Re-qualifications require entry to aseptic areas, tank entry and use of Ellab Datalogger or equivalent.
• Author validation strategies, protocols, execute validations, analyze data and write final reports for projects that support equipment, steam sterilization, process or cleaning validations, among others.
• Conduct periodic reviews of validated equipment and systems as outlined in SVMP.
• Conduct peer reviews of validation packages for fellow team members and provide feedback.
• Perform applicable department responsibilities as defined by Validation Manager / Validation Supervisor and needs of the department.

SCOPE/RESPONSIBILITIES:

Validation Technician will be responsible for supporting tasks outlined in the Site Validation Master Plan (SVMP). These tasks include re-qualifications, periodic reviews and projects supporting capital equipment or process changes. The Validation Technician interacts with various facets of the organization including but not limited to operations, microbiology, chemistry, metrology and maintenance.

Qualifications/Training:

• Education: Associate Degree in Science preferred, BS desirable.
• Desired use of a Ellab (or equivalent data logger).
• Experience: 0-3 years of validation experience, 5 years in Pharma/Medical device industries with manufacturing or QC lab experience.
• Preferred Skills: Self-Driven, Strong Verbal and Written Communication, Strong GMP and Data Integrity knowledge, Strong Interpersonal skills, Results Oriented, quality mindset.

This position may be available in the following location: Greenville, SC

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.