Senior Process Engineer - Radiopharma Equipment Startup

Stark Pharma Solutions Inc

Indianapolis (IN)

Vor Ort

USD 90.000 - 130.000

Vollzeit

Vor 9 Tagen

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Zusammenfassung

Stark Pharma Solutions Inc. in Indiana is seeking a Sr.

Process Engineer with radiopharmaceutical manufacturing experience to support startup, commissioning, troubleshooting, maintenance and new equipment introduction while collaborating with Engineering, Maintenance, Manufacturing and Quality teams. The role requires a Bachelor's degree in Engineering, experience with isolators or containment equipment, and strong problem-solving and GMP documentation knowledge.

Qualifikationen

Bachelor's degree in Engineering or a related technical field.
Experience in radiopharmaceutical manufacturing.
Experience with isolators or containment equipment.
Experience with equipment commissioning, startup, and maintenance.

Aufgaben

Support startup, commissioning and troubleshooting of pharmaceutical manufacturing equipment.
Assist with equipment installation, startup, and qualification activities.
Coordinate with Engineering, Maintenance, Manufacturing, and Quality teams.
Maintain GMP engineering documentation and change controls.
Support deviations, CAPAs and root cause investigations.
Assist with new equipment introduction and improvements.
Support equipment qualification and validation activities.
Ensure compliance with GMP and regulatory requirements.

Kenntnisse

Strong problem-solving

Excellent communication

Ausbildung

Bachelor's degree in Engineering or related technical field

Tools

Radiopharmaceutical equipment

Isolators/Containment equipment

Equipment troubleshooting

Process validation

Jobbeschreibung