Scientist/Engineer, Technical Operations - Lilly Medicine Foundry

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a hands-on operations professional to support on-floor activities and drive process improvements in a fast-paced biotech manufacturing environment. You will participate in production, QA/QC, deviations, and safety investigations while coordinating with maintenance and cross-functional teams.

Responsibilities include coordinating campaigns, changeovers, and technology transfers under cGMP conditions and contributing to ongoing continuous improvement efforts within

Qualifications

• Bachelor's degree in science/engineering or related field; or HS Diploma with 5+ years pharma ops experience.
• Experience with regulatory compliance and investigations (FDA/cGMP) preferred.
• Ability to author procedures and instructions; perform process hazard reviews.

Responsibilities

• Provide on-floor support for operations staff and, at times, perform production activities.
• Evaluate processes, deviations, and impacts; support cross-functional teams.
• Lead commissioning/qualification activities under C&Q guidance with independent judgment.
• Document production per digital batch records and SOPs; adhere to quality/regulatory requirements.
• Coordinate maintenance work orders and corrective actions with maintenance teams.
• Lead safety and quality investigations; author investigation reports.
• Support technology transfers; drive operational improvement projects.
• Create project plans for campaigns/changeovers and ensure timelines are met.
• Collaborate with PE, PTE, PRD, HSE, and QA to ensure successful transfers.
• Apply HSE/process safety standards and contribute to venues like PHR/HSE.
• Promote continuous improvement of changeover workflows in a fast-paced team.

Skills

Operations experience

QA/QC & cGMP knowledge

Changeover optimization

Cross-functional collaboration

Documentation & deviation handling

Education

Bachelor's in science/engineering

HS Diploma with 5+ years experience

Tools

cGMP systems

Process safety knowledge

Job description

Responsibilities

• Provide on-floor shift support for operations staff for technical, training, and process support; at times execute production activities.
• Evaluate processes/protocols and real-time deviations; assess impacts and support cross-functional process teams.
• Execute equipment commissioning and qualification testing under C&Q guidance using independent judgment.
• Conduct and document production per digital batch records and affiliated SOPs; adhere to cGLP/cGMP, procedures, and quality/regulatory requirements.
• Document and assess improvement opportunities from operators.
• Coordinate corrective maintenance with area maintenance (work orders).
• Lead safety and quality investigations; author investigation reports.
• Support foundry technology transfers; serve as a resource for operational improvement projects.
• Create and execute project plans for process campaigns/changeovers (cleandown, piping, maintenance, equipment setup); coordinate to meet timelines.
• Work cross-functionally with PE, PTE, PRD, HSE, and QA to ensure successful transfer and execution.
• Apply HSE/process safety standards and represent operations in PHR and HSE venues.
• Promote continuous improvement of changeover workflows; collaborate in a fast-paced team.

Basic Requirements

• Bachelor’s or Associate’s in science/engineering or technical field; OR HS Diploma/GED with 5+ years pharmaceutical manufacturing operations experience (Small Molecule/Biologics/Mixed Modalities), including operations, incident investigations, procedure/instruction authoring, and process hazard reviews.
• Authorized to work in the United States full-time; no visa sponsorship.

Additional Preferences

• Pharmaceutical product R&D; GMP cleaning/changeover/maintenance support; project management training; leadership/influencing; facility/area start-up experience; FDA/cGMP knowledge; lean principles; troubleshooting/triage; technical nomenclature/math; strong written/verbal communication.

Other

• Travel: ~5%; on-site M–F with flexibility for 24/7 operations (nights/weekends as needed).