Associate Director – TS/MS Validation
3 weeks ago
Want to see how your resume matches up to this job? A free trial of our JobsAI will help With over 2,000 biopharma executives loving it, we think you will too Try it now — JobsAI. Role Summary Associate Director ’ ī TS/MS Validation. Responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group, including cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and qualification of equipment, facilities, and utilities. Supports day-to-day TS/MS validation activities and plans for the 3-6 month horizon. Responsibilities Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including interactions of chemistry, equipment, aseptic processes, and container closure systems. Support Site Leadership to build a diverse and capable TS/MS organization across validation areas. Provide technical guidance to the TS/MS group. Participate in strategies for Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA). Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections. Manage external contracts/resources and project management resources as needed. Develop and maintain validation program documents including SOPs and Master Plans. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, and validation master plans. Lead TS/MS technical projects to improve start-up, process control, yield, product quality, and productivity. Work within or lead cross-functional teams to implement TS/MS validation objectives and deliver on business and quality objectives. Network and collaborate with global and other parenteral sites to share knowledge and plan strategically. Ensure a safe working environment and participate in safety-related activities. Qualifications BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related scientific discipline Minimum 1 year of management or leadership experience with cross-functional groups Minimum 5 years of regulated industry experience Previous experience with aseptic manufacturing Additional Skills Strong technical aptitude with ability to train and mentor others Excellent interpersonal, written, and oral communication skills across organizational levels Solid understanding of regulatory requirements from FDA, EMEA, OSHA Experience supporting cGMP manufacturing in operations, Technical Services/MSAT, QA, etc. Facility or area start-up experience Equipment qualification and process validation experience Experience with highly automated equipment Experience with deviation and change management systems (e.g., MasterControl) Education Degree in relevant field as listed in Qualifications Additional Requirements Role is Monday through Friday with flexibility to support production schedules, occasional extended hours or off-hour work as required #J-18808-Ljbffr
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Associate Director – TS/MS Validation
2 weeks ago
Pleasant Prairie, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Associate Director, TS/MS Validation Leader
2 weeks ago
Pleasant Prairie, United States Eli Lilly and Company Full timeA global healthcare leader is seeking an Associate Director of Validation in Pleasant Prairie, WI. The role involves managing the TS/MS validation group, overseeing cleaning and sterilization validations, and ensuring compliance with regulatory standards. A strong technical background and previous leadership experience in a regulated industry are essential...
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Associate Director
2 weeks ago
Pleasant Prairie, WI, United States Eli Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Sr. Principal Engineer – TSMS Visual Inspection
2 weeks ago
Pleasant Prairie, United States Eli Lilly and Full timePosition Overview The Visual Inspection Engineer – Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes. The role is responsible for teaching, mentoring, and coaching personnel in all aspects relating to visual inspection processes...
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Pleasant Prairie, WI, United States Eli Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Pleasant Prairie, Wisconsin, United States Eli Lilly and Company Full time $111,000 - $178,200 per yearAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Pleasant Prairie, WI, United States Eli Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Pleasant Prairie, Wisconsin, United States Eli Lilly and Company Full time $111,000 - $178,200 per yearAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Sr. Principal Engineer – TSMS Visual Inspection
3 weeks ago
Pleasant Prairie, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Pleasant Prairie, United States Eli Lilly and Company Full timePosition Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines. The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha...
