TS/MS Visual Inspection Secondary Loop

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Assist in driving the technical agenda for syringe visual inspection platform, including Manual, Semi-Automatic, and Automatic inspection, including continuous improvement, compliance initiatives, process control, yield, and/or productivity.
• Provide technical support to non-routine (e.g., deviation, process removal) investigations, including consultation on quality issues, resort recommendations, and process changes.
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation (process and cleaning, sterility assurance, etc) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross- functional teams in positive fashion to implement technical objectives and deliver on business plan, quality objectives or to improve process control, yield, and/or productivity.

Basic Requirements:

• Bachelor's Degree in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Pharmacy, or Engineering are required.
• 2+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Strong technical aptitude
• Proven Teamwork and interpersonal skills
• Decision making
• Problem solving
• Oral and written communication skills that demonstrate an ability to effectively (e.g., clearly, succinctly) communicate with all levels of the organization.
• Ability to influence groups and communication skills
• Previous experience with deviation and change management systems
• Previous experience with visual inspection or defect classification - components incoming inspection and/or drug product inspection.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Information:

• Role is Monday through Friday based.
• Must be flexible in providing support to 24/7 operations
• Occasional extended hour and / or off-hour work may be required.
• Minimal travel required

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$67,500 - $173,800

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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