Sr. Engineer - Commissioning, Qualification, and Verification

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.

Organization 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 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.

This role is at the CORE Indianapolis facility, formerly Point Biopharma. The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches. This role will report within the Facilities and Engineering team.

Responsibilities:

This position is responsible for supporting commissioning, qualification, and validation for process equipment and ancillary components at the Lilly CORE Indianapolis facility. This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Development, and Regulatory departments.

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas.

Key Responsibilities:

• Apply thorough understanding of regulator requirements, relevant SOP curriculum, project procedures, project management, and other training to support equipment/system commissioning, qualification, and validation activities.
• Assess, qualify, and validate equipment, critical systems (utilities), facilities, computer system, cleaning, manufacturing, and processes by authoring and supporting the execution of commissioning, qualification, and validation documentation and reports.
• Understand the scientific principles for pharmaceutical manufacturing, including the interaction of chemistry, equipment, and clean room operation.
• Participate and interface with cross-functional project teams and represent validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle asset management: Design qualification, FAT/SAT, commissioning, engineering, and process validation.
• Understand the equipment requirements based on manufacturing process and chemistry.
• Support periodic requalification activities for production equipment and systems.
• Provide technical support and advice on deviations/events and assist in root cause analysis and trouble-shooting efforts as required.
• Participate or provide guidance for commissioning, qualification, and validation activities during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for the preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, etc.
• Ensure a safe working environment through compliance with safety rules and improve safety culture.
• Provide a positive and equitable working environment emphasizing Lilly's values: Integrity, Excellence, and Respect for People

Minimum Requirements:

• BS degree in Chemistry, Biochemistry, Bio/Chemical Engineering or related discipline
• 3+ years of experience in a cGMP pharmaceutical or device manufacturing facility

Additional Skills/Preferences:

• Knowledge of relevant FDA regulations relating to cGMP pharmaceutical manufacturing.Excellent communication skills, both oral and written.
• Ability to independently master assigned processes and to coordinate activities with internal and external partners.
• Ability to respond quickly and proactively to changing priorities within a limited timeline.
• Experience with Kneat paperless validation software.

Additional Information

• Some weekend work to commence with commercialization (approximately once a quarter)
• Occasional travel may be required for training, conferences, capital projects, etc. (<5% travel, most likely OUS)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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