TS/MS Visual Inspection Secondary Loop

Eli Lilly and Company • Us, IN

8d • Onsite

About The Position

The Visual Inspection Scientist - Secondary Loop provides technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. This person interacts daily with a wide variety of people, including customers, other personnel and site management.

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.

Nice To Haves

• 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.

Responsibilities

• 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.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level