Process Engineer II

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 escalate 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.

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

Our US 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.