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.

　　Sr. Engineer – Validation

　　Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

　　This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will participate in the design, commissioning and start up the facility for both clinical and commercial supply.

　　We are seeking a Validation Engineer at Lebanon Advance Therapies Manufacturing in Lebanon, IN. Validation engineer will be responsible for the following:

　　Equipment/System Validation

　　Life Cycle Asset Management

　　Requalification Activities

　　Temperature Mapping

　　Asset Induction

　　Cleaning / Sterilization (Parts Washer, Autoclave)

　　Support Process and Computer Qualification Activities

　　Lead validation / qualification protocols per continued process verification, risk impact assessments, and support commissioning

　　Core Responsibilities

　　Facility Start-up:

　　Apply thorough understanding of regulatory requirements, relevant SOP curriculum, routine project procedures, project management, and other training to support manufacturing and engineering in projects such as cleaning, sterilization, equipment and utilities commissioning and qualification

　　Assess, qualify, and validate equipment, critical systems (utilities), facilities, computer system, cleaning and steaming processes, manufacturing, and equipment processes, as applicable

　　Participate and interface with cross-functional project team and represent validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: design qualification, FAT/SAT, commissioning, engineering, and process validation

　　Provide a positive and equitable working environment emphasizing the Lilly’s Values: Integrity, Excellence, and Respect for People

　　Provide validation engineering support to site with a strong focus on right first time and on schedule facility start-up (e.g. designreviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness)

　　Represent validation during tech transfer activities identifying current and anticipated requirements for cleaning efforts as required. Lead technical projects as they pertain to cleaning and cleaning validation. Provide technical input to strategy/philosophy for cleaning validation and engineering changes.

　　Support the IQ, OQ, and PQ strategy, design, and execution for LP2 systems and equipment

　　Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, Lilly procedures, and regulatory requirements

　　Facility Operations:

　　Develop and maintain the basis of safety for equipment as required

　　Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team

　　Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control

　　Monitor, assess and document equipment performance to maintain ongoing qualification

　　Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions

　　Basic Qualifications

　　Bachelor's Degree in Chemical, Process, or Mechanical Engineering

　　Experience in cleaning process, process equipment, facilities and GMP critical support systems

　　Minimum of three (3) years of relevant experience in regulatory, quality, validation, and /or manufacturing operations

　　Additional Skills/Preferences

　　Deep technical interest and understanding in the field of Chemical Engineering

　　Strong analytical and problem-solving skills

　　Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals

　　Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented

　　Guidance/mentoring of others through processes

　　Flexibility to meet business needs

　　KNEAT Experience

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