Process Engineer II

Bausch & Lomb GmbH; Greenville, Northern (SC, KY); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Bausch + Lomb in Greenville, SC, is seeking an Aseptic Process Engineer and Core Coach to strengthen sterility and coaching on the shop floor. You will support aseptic training, observe high-risk activities, and ensure GMP documentation across continuous manufacturing operations.

The role requires a bachelor’s degree in a scientific/technical field and at least four years of aseptic manufacturing experience, with strong analytical and communication skills to drive quality and compliance.

Qualifications

• Bachelor’s degree in microbiology, biology, chemistry, engineering, pharmaceutical sciences, or a related technical field.
• At least 4 years in aseptic manufacturing or related cGMP environment.
• Knowledge of aseptic processing, cleanroom behavior, contamination control, and environmental monitoring.
• Experience delivering hands-on training and coaching in manufacturing.
• Strong analytical, writing, and communication skills.

Responsibilities

• Maintain routine presence in classified manufacturing areas and observe gowning, cleaning, disinfection, material transfer, and high-risk activities.
• Provide timely coaching to personnel and leaders; reinforce compliant practices and escalate concerns as needed.
• Serve as SME for aseptic behaviors, cleanroom discipline, contamination control, and microbiological controls.
• Support development, qualification, requalification, and effectiveness assessment of aseptic training including gowning, interventions, disinfection, and material transfer.
• Observe aseptic process simulations and airflow studies; evaluate practices against procedures and contamination control principles.
• Document observations and follow-up actions per Good Documentation Practices and data integrity requirements.
• Trend data on training outcomes and monitoring to identify systemic improvement opportunities and CAPA.
• Participate in investigations involving aseptic practices, monitoring events, media fills, and risk management; provide objective input for root-cause analysis.

Skills

Aseptic processing

Cleanroom discipline

Environmental monitoring

GMP documentation

Training and coaching

Education

Bachelor’s degree in microbiology/biology/chemistry/engineering/pharmaceutical sciences

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:

This position serves as a dedicated aseptic process engineering and Aseptic Core Coach resource for sterile solutions manufacturing. The role strengthens sterility assurance and contamination control by providing routine shop-floor observation, real-time coaching, technical support, and data-driven improvement of aseptic behaviors, interventions, process execution, training effectiveness, and GMP documentation. The position partners cross-functionally to reduce aseptic and compliance risk, support reliable manufacturing performance, maintain audit and inspection readiness, and sustain alignment with applicable company procedures and global regulatory expectations.

Key Activities/Responsibilities:

• Maintain a routine, visible presence in classified manufacturing areas and observe gowning, setup, disinfection, material transfer, aseptic connections, line clearance, interventions, environmental and personnel monitoring interfaces, and other high-risk activities.
• Provide timely, respectful, and specific coaching to personnel and leaders. Reinforce compliant practices, address at-risk behaviors in real time when appropriate, and elevate quality, sterility assurance, safety, or compliance concerns in accordance with site procedures.
• Serve as a technical subject matter resource for aseptic behaviors, cleanroom discipline, contamination control principles, microbiological controls, and human-factor risks that may affect product quality or sterility assurance.
• Support the development, delivery, qualification, requalification, and effectiveness assessment of aseptic training, including gowning, aseptic interventions, disinfection, material transfer, and related job-function curricula.
• Observe aseptic process simulations/media fills and airflow visualization or smoke studies. Evaluate operator practices, interventions, and process conditions against approved procedures and established contamination control principles.
• Document coaching observations, positive practices, recurring gaps, and follow-up actions accurately, contemporaneously, and in accordance with Good Documentation Practices and applicable data integrity requirements.
• Trend observation data, training outcomes, personnel monitoring information, environmental monitoring awareness indicators, deviations, and recurring behavioral risks to identify systemic opportunities and recommend sustainable corrective or preventive actions.
• Participate in investigations involving aseptic practices, environmental or personnel monitoring events, media fills, contamination concerns, or human-performance factors. Provide objective observations and technical input to root-cause analysis, CAPA development, and effectiveness checks.
• Support implementation, continual improvement, and maintenance of the site Contamination Control Strategy (CCS) by identifying critical personnel and process risks and reinforcing controls through coaching, training, procedural adherence, and risk-based decision-making.
• Evaluate proposed equipment, facility, process, procedure, or tool changes for potential impact on aseptic technique, cleanability, intervention design, airflow protection, and contamination control; communicate recommendations to the appropriate functions.
• Collaborate effectively with Manufacturing, Quality Assurance, Quality Control/Microbiology, Engineering, Maintenance, Technical Services, Validation, Training, Regulatory Affairs, and site leadership to improve aseptic process capability and standardize best practices.
• Support internal audits, customer audits, and regulatory inspections by maintaining inspection-ready records and serving as an aseptic processing and contamination control subject matter resource, as assigned.
• Apply data analysis, quality risk management, root-cause analysis, Lean/process excellence, and continuous improvement methods to improve quality, process efficiency, right-first-time execution, and compliance.
• Remain current on approved procedures, required training, cGMP expectations, aseptic processing principles, and relevant regulatory guidance. Provide technical support for operations that may require coverage outside normal business hours.

SCOPE/RESPONSIBILITIES:

This position supports sterile solutions manufacturing as an aseptic process engineer and Aseptic Core Coach. The role provides shop-floor coaching, technical assessment, training and qualification support, contamination control and sterility assurance input, investigation support, data trending, and continuous improvement across applicable manufacturing areas and shifts. Responsibilities may require support of a continuously operating manufacturing environment.

Qualifications/Training:

• Education: Bachelor’s degree in microbiology, biology, chemistry, engineering, pharmaceutical sciences, or a related scientific/technical discipline required. An equivalent combination of relevant education and demonstrated aseptic manufacturing experience may be considered in accordance with company requirements.
• Experience: Minimum of 4 years of progressively responsible experience in aseptic manufacturing, sterile operations, quality, microbiology, process engineering, sterility assurance, or a related cGMP environment.
• Demonstrated working knowledge of aseptic processing, cleanroom behavior, contamination control, environmental and personnel monitoring concepts, aseptic process simulations/media fills, airflow visualization/smoke studies, Good Documentation Practices, data integrity, deviation investigations, CAPA, and quality risk management.
• Experience providing hands-on training, qualification support, or behavioral coaching in a controlled manufacturing environment. Ability to give clear feedback, influence across functions, and promote sustained behavior change.
• Strong analytical, problem-solving, technical writing, communication, and organizational skills. Ability to evaluate data and observations, identify risk trends, document conclusions objectively, and manage multiple priorities.
• Current cGMP and site-required training are mandatory. Process validation, Lean/process excellence, root-cause analysis, and regulatory inspection support experience are preferred.
• Ability to support a continuously operating manufacturing environment, including periodic off-shift or weekend support, as business needs require.

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

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.

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.