Principal Engineer, Aseptic Process

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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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. 

Purpose of Job:

This engineer will manage and/or lead aseptic equipment, utilities, facility and/or process engineering activities for development, capacity expansion, continuity of supply and maintenance of business functions.

Key Activities:

1. Serve as the Aseptic Solutions Engineering technical team member on cross functional teams, responsible for defining engineering project plans, developing design requirements, specification/URS definition, equipment/process testing and optimization, manufacturing process development while ensuring regulatory and quality compliance with current standards (FDA, ISO, cGMP) and industry best practices.
2. Guide GVL site modernization projects including the use of RABS filling technology and Aseptic core upgrades with optimized material and people flows.
3. Lead engineering activities including technology transfer of manufacturing processes to support the design and development of new and innovative aseptic processing approaches for existing products and R&D pipeline products.
4. Identify new technologies and equipment that will reduce manufacturing and material costs and improve efficiencies.  Develop business case/justification around potential opportunities for review with leadership.
5. Recommend equipment suppliers, consultants, contractors and participate in the supplier evaluation, selection and qualification process.
6. Lead critiques of new/modified equipment and/or manufacturing process designs for robustness as it relates to product quality, process performance, and regulatory compliance.
7. Manage, create and execute design of experiments to establish robust manufacturing process performance.

         8.  Lead and/or coordinate root-cause analysis and remediation of equipment and/or manufacturing process issues with established platforms.

        9. Manage equipment qualifications and validations with generation of appropriate documentation.

        10. Manage multiple projects effectively.

Scope of Position:

Function as the Global Engineering technical leader in a matrix organization across development teams, manufacturing scale-up, and maintenance of business function.

An influential leader responsible for the technical direction of the team in the area of aseptic liquid solutions engineering.  May manage project portfolios for Sustaining Engineering and/or MOB activities.  Will interface with multiple organizations, sites and CMO’s in leading such projects.  Can provide daily direction to technical team members assigned to project teams.

Key Relationships:

Ability to lead cross-function teams for both development and manufacturing scale-up activity.

Manage activities with external equipment suppliers, internal or external manufacturing sites, and external consultants and contractors.

Responsible for communication across manufacturing sites, R&D, Commercial, and Engineering management.

Qualifications:

BS/MS in Mechanical or Chemical Engineering or related Engineering discipline.

10+ yrs. process engineering experience with aseptic pharmaceutical products and/or medical devices.

Project Management and Six Sigma/DOE experience, training or certification desired.

ISO-9000, GMP.

1. Experience in leading technical activities for aseptic process development and manufacturing.
2. Demonstrated skills in aseptic manufacturing process design and capital equipment design/selection and qualification.
3. Project and team management.
4. Knowledge of Pharmaceutical and/or Medical Device Regulations is required.
5. Strong troubleshooting and analytical capabilities with experience in DOE.
6. Position requires strong communication and interactive skills, capable of leading and directing project teams as required.
7. Experienced with Product & Process Development Phase/Gate Methodology.

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This position may be available in the following location(s): US - Greenville, SC (Plant)
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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.

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To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

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