Pharma Process Validation & Lifecycle Lead

Bayer AG; Myerstown (PA); On-site; USD 87,000 - 131,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer AG in Myerstown, PA is seeking a Process Technology Scientist specializing in Validation and Product Life Cycle Management. You will lead process validation, equipment qualification, cleaning validation, and lifecycle activities across OTC and Nutritional formulations.

Responsibilities include technical leadership, cross-functional collaboration, and driving continuous improvement while ensuring regulatory compliance and scale-up success within a GMP environment.

Qualifications

• 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.

Responsibilities

• 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 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.
• 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-decel performance, innovation, digitalization, safety culture, and team engagement.

Skills

Root cause analysis

Troubleshooting

Data analysis

Technical writing

Communication skills

Cross-functional collaboration

Leadership

Education

Bachelor's degree in pharmacy/chemical engineering/chemistry/pharmaceutical sciences

Master's degree in chemical engineering/chemistry/pharmaceutical sciences

Tools

SAP

SCADA

MES

ValGenesis

PDV

Job description

Bayer AG in Myerstown, PA is seeking a Process Technology Scientist specializing in Validation and Product Life Cycle Management. You will lead process validation, equipment qualification, cleaning validation, and lifecycle activities across OTC and Nutritional formulations.

Responsibilities include technical leadership, cross-functional collaboration, and driving continuous improvement while ensuring regulatory compliance and scale-up success within a GMP environment.