Engineer, Downstream Technical Services

Lilly • Indianapolis, IN

11d • $67,500 - $118,800 • Onsite

About The Position

This position is part of the Bioprocess Development (BR&D) organization. The individual in this role will be responsible for technical support for production of drug substance (DS) in the K360 Clinical Trials Manufacturing Facility. They will interface with development, operations, automation, and maintenance groups providing process and/or equipment technical oversight as required.

Several different processes run in the bioprocess pilot plant over the course of a year and each may be in a different stage of clinical development. The individual in this role provides technical oversight to the operations group leading to production of drug substance (DS) for development and clinical trial purposes while maintaining compliance to current Good Manufacturing Practices (cGMPs).

Requirements

• Earned Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline
• 1+ year of hands-on experience in large molecule protein purification techniques (at pilot scale) and familiarity with protein purification principles
• Previous experience with tech transfers in a manufacturing environment
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management
• Strong problem-solving skills

Nice To Haves

• Background in GMP production environments
• Prior work in a biotech/pharmaceutical environment
• Proficient in DeltaV, PLCs, AKTA and/or Unicorn
• Understanding of computer system validation and equipment qualification

Responsibilities

• Lead incoming and outgoing process tech transfers, including preparation of required tech transfer documents, production batch records, and required materials and consumables.
• Oversee scheduling of key tasks in operations Identification and implementation of process changes and process improvements.
• Ensure the appropriate health, safety and environmental assessments are completed during tech transfers
• Active process monitoring of ongoing campaigns or in process equipment
• Input or authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable
• Ensure processes/equipment are compliant with cGMP expectations where applicable
• Document studies in lab notebooks and author technical reports where applicable
• Troubleshoot and investigate production issues and process excursions during DS manufacturing campaigns
• Active engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing

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