CQV Validation Engineer Sterile Fill/Finish Onsite

Katalyst CRO; Springfield (MA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Katalyst CRO is seeking onsite Validation Engineers to support qualification work tied to sterile manufacturing and fill/finish operations. You will perform hands-on OQ/PQ execution, GMP documentation, protocol execution, and address discrepancies to drive qualification deliverables to completion.

The ideal candidate brings direct validation or CQV experience in GMP environments, with exposure to aseptic filling, sterilization equipment, and high-speed fill lines.

Qualifications

• Hands-on validation/CQV experience in GMP environments.
• Experience with aseptic fill/finish and sterile manufacturing.
• Strong OQ/PQ execution and rapid protocol documentation.

Responsabilités

• Perform onsite OQ/PQ execution for sterile manufacturing equipment.
• Develop and execute qualification protocols, document in real time.
• Support discrepancies/deviations and drive closeout of packages.

Connaissances

Hands-on validation

CQV experience

OQ/PQ execution

Documentation

Independent onsite work

Aseptic filling

Fill/finish

GMP documentation

Protocol execution

Deviation support

Formation

Bachelor's degree in Engineering, Life Sciences, or related

Outils

Kaye validators

Wireless probes

Protocol execution tools

Description du poste

Katalyst CRO is seeking onsite Validation Engineers to support qualification work tied to sterile manufacturing and fill/finish operations. You will perform hands-on OQ/PQ execution, GMP documentation, protocol execution, and address discrepancies to drive qualification deliverables to completion.

The ideal candidate brings direct validation or CQV experience in GMP environments, with exposure to aseptic filling, sterilization equipment, and high-speed fill lines.