Technical Operations Scientist & Engineer, GMP

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

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