This position is for a Subject Matter Expert (SME) for Lyophilization (also referred to as Freeze Dry or Lyo) operations. The scope of the role includes support of Lyophilization related capital projects and operational support of existing Lyophilization operations. Key accountabilities include ensuring that the existing lyophilizers are functioning at an optimal state and that all new lyophilizers or modified lyophilizers function as intended to successfully manufacture drug products on schedule, ensuring all product is produced in a manner meeting safety and quality requirements.
Serves as subject matter expert on lyophilizer and/or automated loading/unloading systems. As responsible person for functionality of the lyophilization equipment, interfaces closely with operators, freeze dry leadership, maintenance, and quality to ensure the lyophilizers are functioning as intended.
Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
Investigates deviations that arise during lyo cycles. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
Competent at reviewing lyo data trends to determine level of functionality of the equipment and processes to ensure all validated criteria are met and equipment is performing at optimal levels.
Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, Biomedical Engineering) or Life Sciences (Chemistry, Biochemistry, Microbiology) & a minimum of 5 years of relevant manufacturing experience OR a master’s degree in engineering or science and a minimum of 3 years of relevant manufacturing experience.
Strong aptitude for learning process technology and equipment
Excellent written and oral communication skills
Demonstrated ability to interact effectively with all levels of the organization including diverse educational and cultural backgrounds.
Flexibility and ability to embrace and lead chance
Ability to work in a high-paced team environment
Manufacturing experience with lyophilization equipment or unit operations common to lyophilization (wet/dry vacuum pumps, mechanical cooling, liquid nitrogen cooling, heat exchangers, and process control systems) are preferred.
Experience in a cGMP environment including specific knowledge of and experience with Drug Product processing and equipment is desired.
• Physical Demands: Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts. Must be able to perform gowning requirements for entry in the manufacturing areas.
Requires lifting, sitting, standing, walking, stair climbing and roof access.
• Work Environment: Office environment, with frequent time in the manufacturing areas. Possible exposure to high noise environments, solvents, and pharmaceutical ingredients. Use of hearing and eye protection is required. Must be available to support 24/7 – 365 operation.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The focus of the work is at the Kalamazoo, MI site, however 0-10% travel may be required to support Factory Acceptance Testing and/or network support.
Other Job Details:
Last Date to Apply: January 9, 2021
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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