Associate Director – TS​/MS Validation

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 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 through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The Associate Director, Validation is responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group. The specific area of responsibility includes cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities. The Associate Director may also provide input/guidance/oversight to the performance of other validation types at the site as needed.

The Associate Director will be responsible for supporting the day‑to‑day TS/MS validation activities as well as planning for the 3‑6‑month horizon.

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Support Site Leadership to build a diverse and capable TS/MS organization, with a focus on supporting the areas of cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities.
• Provide technical guidance to the TS/MS group.
• Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives:
  Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Manage external contracts/resources and project management resources, as needed.
• Manage the development and maintenance of relevant validation program documents including SOPs and Master Plans.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports, etc.
• Support and/or lead TS/MS technical projects to ensure a successful start‑up, improve process control, yield, product quality and/or productivity.
• Work within or lead cross‑functional teams in positive fashion to implement TS/MS validation objectives and deliver on business plan and quality objectives.
• Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety‑related activities.

• BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Minimum 1 year of management or leadership experience, including leading or working effectively with a cross‑functional group
• Minimum 5 years of regulated industry experience
• Previous experience with aseptic manufacturing

• Strong technical aptitude and ability to train and mentor others
• Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, and OSHA.
• Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.)
• Previous facility or area start‑up experience
• Previous equipment qualification…