Radiopharma Process Engineer - Sterile & Validation

Alexander Technology Group; Billerica (MA); Vor Ort; USD 55.000 - 69.000; Vollzeit

Zusammenfassung

Alexander Technology Group seeks a Back Process Engineer QA Analyst (Hardware) in Billerica, MA. This role supports radiopharmaceutical manufacturing with hands-on cGMP experience, ensuring compliance and continuous improvement.

The candidate will lead investigations, author technical docs, and collaborate across Manufacturing, QA, QC, and Supply Chain to ensure timely, compliant campaigns. 6+ years in sterile manufacturing and strong data analysis skills are essential.

Qualifikationen

• Bachelor’s degree in a technical field required.
• 6+ years in medical device manufacturing, with sterile injectable or radiopharmaceutical focus preferred.
• Strong knowledge of cGMPs, aseptic processing, cleanroom operations, and related regulations.
• Demonstrated ability to investigate deviations, apply root cause analysis, and implement changes within a quality system.
• Hands-on experience with equipment used in sterile fill/finish operations.
• Experience leading process validation, equipment qualification, and risk management efforts.

Aufgaben

• Provide day-to-day technical support to manufacturing operations.
• Lead investigations of deviations and implement CAPAs with QA and operations.
• Author and revise manufacturing docs, reports, protocols, and risk assessments.
• Support process monitoring, data analysis, and continuous improvement.
• Participate in cross-functional teams for process changes and validations.
• Lead technical transfers, scale-ups, and lifecycle projects.

Kenntnisse

Problem solving

Data analysis

Technical writing

Communication

Ausbildung

Bachelor’s degree in Chemical Engineering or related

Advanced degree preferred

Tools

TrackWise

CATSWeb

Excel

Jobbeschreibung

Alexander Technology Group seeks a Back Process Engineer QA Analyst (Hardware) in Billerica, MA. This role supports radiopharmaceutical manufacturing with hands-on cGMP experience, ensuring compliance and continuous improvement.

The candidate will lead investigations, author technical docs, and collaborate across Manufacturing, QA, QC, and Supply Chain to ensure timely, compliant campaigns. 6+ years in sterile manufacturing and strong data analysis skills are essential.