The Principal Quality Engineer will play a critical role supporting the Maintenance of Business (MOB) activities for Bausch + Lomb’s Global Vision Care engineering team. Responsibilities will include process improvements, secondary supplier evaluations, raw material changes, investigation of customer complaints and compliance related activities. The Principal Quality Engineer will support Global Vision Care development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility. This role will provide Quality Assurance consultation to global manufacturing sites as needed, as well as collaborate with multidisciplinary teams to ensure medical device Maintenance of Business and development activities are planned and executed in compliance with Global GMP standards, Bausch + Lomb policies and procedures.
Specific Job Duties:
Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely 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.
- Represent Global Vision Care Quality on multidisciplinary new product development teams.
- Provide support for product and process improvements as they relate to Maintenance of Business (MOB). Support includes collaboration with multidisciplinary teams setting direction, approving protocols and reports, managing and prioritizing schedules, evaluating specifications (reference standards, product and raw material), reviewing aseptic processing and applying quality engineering principles as needed to support the MOB portfolio.
- Review/Approve GMP documentation including development, method validation and stability protocols and reports, statistical analysis of analytical and process data and review of microbiological data related to disinfection efficacy, preservative efficacy and sterility.
- Ensure project plans adequately address GMP and Quality departmental requirements and standards. Work with functional departments to ensure plans are executed compliantly.
- Management and documentation of Design Control activities through post launch review. Review and approve documentation supporting clinical trial material release.
- Facilitate GMP product readiness and launch activities, including technology transfer and validation.
- Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.
- Develop and implement Quality agreements between Bausch + Lomb and contract sites.
Bausch + Lomb is an equal opportunity employer.
Education: Bachelor’s Degree (BS) in scientific or engineering discipline required, graduate degree a plus. Strong chemistry skills are desired.
Experience: Minimum 10 years’ experience in Medical Device or Pharmaceutical Industry required, ideally in Analytical Chemistry Laboratory and/or Quality.
Additional Skills required:
- Strong background in Analytical Chemistry
- Strong understanding of Aseptic Processing
- Relationship building skills
- Excellent communication (verbal and written) skills
- Experience working in a changing environment and fast-paced organization as a member of cross-functional teams (Quality, R&D, Regulatory Affairs and Global Quality & Operations).
- Experience in Project Management is a plus.
- Medical Device and Pharmaceutical GMP regulations and guidelines.
- Aseptic Processing Training strongly desired.
- Analytical Method development, strongly desired.
- Risk Management Regulations related to Medical Devices, strongly desired.
Currently there are no direct or indirect reports associated with this position.
United States-New York-Rochester Global Eye Health Center Site
Bausch + Lomb - 19 months ago