(Archived) Manager, Production Maintenance

Description

Duties & Responsibilities

• Manage and direct Production Maintenance supervisors to drive efficient and effective utilization of resources.
• Provide recommendations or input for process, PM or asset strategy improvements.
• Assist the production group with technical problems and operational issues.
• Actively participate with a diverse group of individuals in a team effort to identify root causes and subsequent implementation of corrective measures, with subsequent tracking and trending of operations.
• Support the development of Maintenance procedures to enhance equipment reliability.
• Manage the production maintenance department and inter relationships with peers, support organizations, Production, Quality and R&D functions.
• Enforce compliance with regulatory requirements and corporate policies.
• Write, oversee and approve departmental procedures.
• Support Maintenance Management System for building and equipment systems.
• Perform CAPA Investigations and Change Control as required by Quality Assurance.
• Manage, oversee and direct all Maintenance operations related to filling and lyophilization operations.
• Plant Maintenance (PM) Key User/Single Point of Contact (SPOC)
• Facilitate end user training for new role assignments as well as any training requirements resulting from new template releases.
• Provide first level support, troubleshooting and diagnosis of issues within the SAP PM processes. Escalate issues if necessary through defined GBS processes.
• Identify system enhancements necessary to support continuous improvement of SAP utilization for PM and escalate them through Demand Management process defined GB S.
• Collaborate with international colleagues in demand URS development as well as the identification and execution of testing and training requirements for demand implementations.
• Track and communicate the overall PM status to the local SAP Run Organization as the single point of contact (SPOC) as well as communicate any information received to the local PM organization.
• Monitor PM process performance and compliance within the SAP system.
• Working understanding of CGMP requirements, EU Regulatory Requirements, USDA Regulatory requirements, and FDA Regulatory Requirements.
• Prior understanding of pharmaceutical or bio-pharmaceutical standard operating procedures.

Requirements

• Bachelor´s degree from an accredited institution in Engineering, Maintenance or related discipline and minimum six (6) years maintenance, engineering or related experience in a manufacturing environment preferably in the pharmaceutical or biological industry
• OR A minimum of 10 years maintenance, engineering or related experience in a manufacturing environment with relevant maintenance certification and/or apprenticeship in lieu of degree.
• Experience must be inclusive of a minimum of three (3) years leading people and projects, preferably directly related to filling operations.
• Effective interpersonal skills with a demonstrated ability to work with a diverse group of individuals at all organizational levels.
• 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.
• Strong oral and written communication skills to be able to effectively interface with all levels of BIAH personnel and outside consultants.
• Familiarity with the GMP regulatory requirements of biopharmaceutical manufacturing or the food processing industry is desirable.
• Familiarity with other aspects of facilities engineering and maintenance such as buildings and grounds maintenance, janitorial services, transportation equipment, reliability technologies, security are all pluses.
• Organizational skills in planning, goal setting, prioritizing project work and coordinating with operations.

Desired Skills, Experience and Abilities

• Working knowledge of Maintenance Best Practices (Reliability, Planning and Scheduling, Work Execution) strongly desired.