Sr. Validation Engineer

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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