Deviation Resolution Engineer

TALENT Software Services; West Point (PA); On-site; USD 75,000 - 120,000; Full time

Job summary

TALENT Software Services is seeking a QA/Investigation Specialist in West Point, PA to support cGMP manufacturing operations. You will lead investigations, perform root cause analysis and CAPA development, and ensure effective corrective actions are implemented.

The role requires 1–3 years post‑Bachelor experience in pharm/biotech, strong technical writing and verbal communication, and the ability to work independently and with cross‑functional teams in a fast-paced environment.

Qualifications

• B.S./M.S. degree in engineering/science required.
• 1–3 years post‑Bachelor cGMP experience in pharma/biotech.
• Experience writing investigations with root cause analysis and CAPA.
• Familiar with Lean Six Sigma methodologies.
• Strong written/verbal communication and cross‑functional teamwork.

Responsibilities

• Resolution and reduction of process deviations, development and implementation of CAPA.
• Lead manufacturing and laboratory investigations on production floors.
• Provide on-floor technical/scientific support for manufacturing areas within TALENT Software Services’ Manufacturing Division (MMD).
• Develop working relationships with counterparts in aseptic manufacturing, testing, planning, release, and use sound science to investigate deviations.
• Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events; design/execution of lab/pilot-scale experiments.

Skills

cGMP experience

Root cause analysis

CAPA development

Lean Six Sigma

Written & verbal communication

Education

B.S./M.S. degree in engineering/science

Job description

TALENT Software Services is seeking a QA/Investigation Specialist in West Point, PA to support cGMP manufacturing operations. You will lead investigations, perform root cause analysis and CAPA development, and ensure effective corrective actions are implemented.

The role requires 1–3 years post‑Bachelor experience in pharm/biotech, strong technical writing and verbal communication, and the ability to work independently and with cross‑functional teams in a fast-paced environment.