GMP Packaging Validation Engineer

Soltech PR; New Albany (OH); Sur place; USD 89 544 - 103 320; Plein temps

Résumé du poste

Soltech PR in New Albany, Ohio is seeking a Commissioning & Qualification Engineer to lead validation activities for GMP-regulated packaging equipment. The role requires collaboration with teams to maintain compliance and develop crucial qualification documentation.

Ideal candidates will have a relevant degree and over 3 years of experience in commissioning and qualification processes. Join our growing team to impact the pharmaceutical sector significantly!

Qualifications

• 3+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong knowledge of equipment validation lifecycle activities including URS, FAT/SAT, IQ, OQ, and PQ.
• Ability to interpret engineering documentation and experience with pharmaceutical manufacturing processes.

Responsabilités

• Plan and execute commissioning and qualification activities for packaging equipment.
• Develop and review qualification documentation including protocols and test scripts.
• Perform IQ, OQ, and PQ testing to ensure compliance with regulatory standards.
• Support troubleshooting, change controls, deviations, and document readiness.

Connaissances

GMP regulations

Commissioning

Qualification

Validation

Dividella Cartoners

ATS Assembly Systems

Automation systems

Interpret P&IDs

Formation

Bachelor’s degree in Engineering or Life Sciences

Description du poste

Soltech PR in New Albany, Ohio is seeking a Commissioning & Qualification Engineer to lead validation activities for GMP-regulated packaging equipment. The role requires collaboration with teams to maintain compliance and develop crucial qualification documentation.

Ideal candidates will have a relevant degree and over 3 years of experience in commissioning and qualification processes. Join our growing team to impact the pharmaceutical sector significantly!