Validation and Product Life Cycle Management

About the role

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. This role provides technical leadership for process validation, equipment qualification, cleaning validation, process optimization, troubleshooting, technology implementation, and regulatory compliance across manufacturing operations at the Myerstown site.

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.

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.

Preferred Qualifications

• 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.

Pay

Employees can expect to be paid a salary between $87,280.00 - $130,920.00. Additional compensation may include a bonus or incentive compensation.

Benefits

• Health care
• Vision
• Dental
• Retirement
• Paid time off (PTO)
• Sick leave