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.

R&D Equipment Manager

The R&D Equipment Manager leads and manages the GMP Commissioning program of equipment and instruments used in the Morristown Innovation Center. The R&D Equipment Manager ensures the equipment and instruments within the GMP Ops, Analytical and Formulation departments are Qualified, Calibrated and Maintained according to the specified standards and procedures according to GMP compliance.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, R&D Equipment Manager, are to:

• Leading the GMP commissioning and qualification process by drafting and approving protocols/reports, coordinating cross functional activities (including vendors and contractors);
• Managing the Innovation Center's Calibration and Preventive Maintenance program by working with outside contractors;
• Providing guidance and direction to contractors to ensure compliance to procedures;
• Coordinating with equipment vendors when significant repairs are needed;
• Maintaining the Innovation Center's Calibration and PM program in the Laboratory Information System Database;
• Ensuring that Bayer Corporate/CH policies/directives and regulatory authority guidance (GMPs) are followed;
• Initiating equipment/instrument related complex deviations, CAPAs etc. and leading efforts to close out these events;
• Drafting complex SOPs, complex OIs and Best Practices and making sure they are aligned with Bayer Global SOPs;
• Leading cross-functional activities (QA, Legal Development Center) to develop Quality Assurance Agreements with various contractors and vendors;
• Prepare recommendations to management for future budgets / supporting capital equipment procurement, installation and documentation;
• Acting as a mentor to junior colleagues.

WHO YOU ARE

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

Required Qualifications:

• Bachelor's degree;
• Proven experience in equipment design or pharmaceutical manufacturing or analytical or GMP equipment/instrument commissioning and calibration procedures or relevant field (Metrology);
• Experience should be in the Rx, OTC Consumer products industry or similar industry;
• Excellent organizational, communication and collaboration skills;
• Self motivated to learn and develop within the organization.

Preferred requirements:

• Bachelor's degree with at least 4 years of experience OR a Master's degree with at least 2 years of experience;

• Strong understanding of pharmaceutical regulations ( CGMPs, FDA, ICH etc) ;
• Hands on experience in participating with equipment troubleshooting or operation or repairs;
• Project co-ordination experience