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. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Qualification Engineer

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Qualification Engineer, are to:

• 
  Own the Engineering Qualification Process
• The incumbent will support capital project engineers in providing documented evidence that all equipment and utilities are qualified so that they deliver processes and products that comply to regulatory and business specifications
• Write and execute qualification protocols, tests and reports based on user requirements and other relevant information as delivered by project team
• Assist project team in writing project documents as required for commissioning and qualification
• Participate in all qualification activities from capital engineering projects
• Coordinate and support the change control, implementation of GMP Status Review that includes validation master plan, quality impact assessment, GMP risk assessment
• Partner with other functions to establish priorities and schedule activities to ensure project timelines and milestones are met. Routinely communicate project status to stakeholders
• Participate in the development of local standard operating procedures according to global guidelines
• Review and assess the technical system qualification status periodically
• Perform other tasks as assigned by management

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE (Leadership Integrity Flexibility Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor of Science in Engineering, chemistry, or related field required
• Knowledge of qualification and validation requirements for GMP regulated industry preferred
• Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought
• Production experience is preferred

Preferred Qualifications:

• 2 years of GMP regulated industry including facility, utility and equipment commissioning and qualification experience preferred

This role is onsite in Myerstown, PA 5 days a week