Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Group Leader, Lyophilization will provide effective leadership in managing site wide lyophilization maintenance activities. The basic purpose of this role is to ensure that sound corrective, preventive and predictive maintenance practices are performed to obtain reliable operation of critical lyophilization equipment and processes. The incumbent will oversee the successful achievement of all pertinent departmental goals, ensuring that all internal safety and maintenance related GMP compliance requirements and external regulatory requirements are followed. This role will foster an environment of continuous improvement while considering developing personnel skills and provide technical expertise on all lyophilization and supporting equipment throughout the site. This position will also provide technical instructions, training, and development to Lyophilization Maintenance Team during operation and maintenance of these systems. 

Duties & Responsibilities

• Leads all assigned lyophilization maintenance personnel and contractors in assuring all requirements of their assignments and responsibility are clearly communicated and understood.
• Responsible for decision making of lyophilization team regarding adjustment and repair of lyophilization equipment to achieve maximum performance and minimal downtime.
• Manages, oversees, and directs all maintenance operations related to lyophilization equipment.
• Executes Change Controls related to lyophilization equipment as required by Quality Assurance.
• Works with deviations occurring in the lyophilization areas, including root cause analysis, CAPA development, and CAPA implementation.
• Creates, oversees, and approves lyophilization related maintenance procedures.
• Enforces compliance with regulatory requirements and corporate policies related to lyophilization equipment and processes, including but not limited to all EPA refrigeration documentation and RCMS.
• Addresses noncompliance issues in a timely manner with appropriate action plans and required reporting to corporate and regulatory functions.
• Reviews completed work orders and forms for team verifying timely, accurate, and detailed documentation (RCMS, CMMS, etc.).
• Provides leadership and hands-on action for emergency response to lyophilization equipment issues, including being available as required and flexible with work hours including holidays or plant shutdowns.
• Works with Reliability and Process Engineering to improve reliability and performance of lyophilization and supporting equipment.

Requirements

• Bachelor's degree in engineering, maintenance, or related discipline and a minimum of four (4) years refrigeration maintenance, engineering, or related experience in a manufacturing environment preferably in the pharmaceutical or biological industry.

OR

• Minimum of eight (8) years refrigeration maintenance, engineering, or related experience in a manufacturing environment with relevant maintenance certification and/or apprenticeship in lieu of degree.
• Must have an EPA universal certification regardless of education/experience.
• Formal Lyophilization training is desired.
• Must have knowledge with the following: Low temp refrigeration, Vacuum pumps, and ultra-low vacuum systems.
• Desired knowledge of the following: Machine automation and controls, BPE design and high purity process piping, clean steam, and sterilization processes, ASME pressure vessels and code welding, Industrial hydraulics
• Additional requirements: Entry into Medical Surveillance Program (post hire), Ability to work in confined spaces, GMP gowning, 
• Working knowledge of Maintenance Best Practices (Reliability, Planning and Scheduling, Work Execution) strongly desired. 
• Effective interpersonal skills, both oral and written, with a demonstrated ability to work with a diverse group of individuals at all organizational levels, including outside consultants.  
• Proficiency in relevant computer software and programs associated with area. 
• Experience with Microsoft Word and Excel required.  
• Must have attention to detail and commitment to customer service.
• Familiarity with the GMP regulatory requirements of biopharmaceutical manufacturing or the food processing industry is desirable.  
• Organizational skills in planning, goal setting, prioritizing project work and coordinating with operations.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

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Desired Skills, Experience and Abilities