Validation and Product Life Cycle Management

Bayer•Myerstown, PA

3d•Onsite

About The Position

The Process Technology Scientist – Validation and Product Life Cycle Management serves as the site Subject Matter Expert for OTC and Nutritional manufacturing formulation processes and lifecycle management activities at the Myerstown site. This role provides technical leadership for process validation, equipment qualification, cleaning validation, process optimization, troubleshooting, technology implementation, and regulatory compliance across manufacturing operations. The role manages various aspects of process development, including scaling up production processes and improving established production steps for yield, quality, and cost, while coordinating optimization activities, managing resources, ensuring regulatory awareness, and driving competitiveness through cross-functional collaboration and strategic implementation. The position supports a culture of Dynamic Shared Ownership and demonstrates VACC leadership as a visionary, architect, catalyst, and coach while helping evolve the site operating model. It drives performance against key outcomes and KPIs including Right First Time compliance, OEE, UPDT, PDT, Case Fill Rate, cost savings, top-decile performance, innovation, digitalization, safety culture, and team engagement.

Requirements

Bachelor's degree in pharmacy, Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related technical discipline.
Experience in a pharmaceutical, food or FDA-regulated manufacturing environment.
Strong technical knowledge of solid-dose and/or liquid manufacturing processes and lifecycle management.
Experience with process validation, equipment qualification, change management, continuous process monitoring, and validation of lifecycle management activities.
Working knowledge of cGMPs, FDA requirements, OSHA standards, and applicable regulatory expectations.
Experience supporting cleaning validation programs and risk assessments, including risk-based decision making.
Strong root cause analysis, troubleshooting, technical writing, data analysis, and problem-solving capabilities.
Demonstrated ability to collaborate effectively across all organizational levels with strong written and verbal communication skills.
Demonstrated leadership behaviors aligned with the VACC model.

Nice To Haves

Master's degree in chemical engineering, Chemistry, Pharmaceutical Sciences, or related technical discipline.
Experience supporting FDA inspections, corporate audits, and other regulatory inspections.
Knowledge of statistical process control and data analytics.
Experience driving automation, digitalization, and continuous improvement initiatives.
Experience implementing new manufacturing technologies and advanced process controls.
Experience with manufacturing systems including SAP, SCADA, MES, ValGenesis, and PDV.
Experience with Enterprise Resource Planning and Manufacturing Execution System software.

Responsibilities

Serve as the Subject Matter Expert for OTC and Nutritional manufacturing formulation processes and own lifecycle management activities including validation, qualification, change control, process monitoring, and continuous improvement.
Develop and execute validation and qualification strategies including process validation, IQ/OQ protocols, bulk hold studies, and associated technical documentation.
Maintain the validated and qualified status of manufacturing equipment, processes, facilities, and critical systems in compliance with regulatory requirements and Bayer standards.
Support new product introductions, technology transfers, scale-up activities, and manufacturing process changes while identifying opportunities to improve efficiency, yield, quality, and reliability.
Own and maintain the site Cleaning Validation Program, including protocols, reports, risk assessments, lifecycle documentation, cleaning acceptance criteria, and worst-case product assessments for manufacturing and packaging equipment.
Lead continuous process monitoring and data-driven improvement initiatives focused on safety, quality, reliability, productivity, cost savings, innovation, and digitalization.
Provide Subject Matter Expert support for manufacturing troubleshooting and operational improvements and collaborate closely with Core Operations, Quality, Engineering, Supply Chain, Operational Excellence, Manufacturing IT, and Center of Excellence teams.
Support a culture of Dynamic Shared Ownership and demonstrate VACC leadership as a visionary, architect, catalyst, and coach while helping evolve the site operating model.
Drive performance against key outcomes and KPIs including Right First Time compliance, OEE, UPDT, PDT, Case Fill Rate, cost savings, top-decile performance, innovation, digitalization, safety culture, and team engagement.