Validation Specialist

Creative Solutions Services, LLC; Newark (NJ); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment. You will lead validation efforts across equipment, facilities, utilities, and processes, ensuring compliance with GMP, GxP, and FDA regulations.

The role requires hands-on IQ, OQ, and PQ, strong technical writing, and the ability to collaborate with Engineering, Quality, Manufacturing, and Validation teams to deliver robust validation documentation and

Qualifications

• 10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
• Hands-on experience with IQ, OQ, and PQ.
• Experience with equipment, facility, utility, or process validation.
• Strong knowledge of GMP, GxP, and FDA regulations.
• Experience developing and executing validation protocols and reports.
• Experience with deviations, CAPA, change controls, and risk assessments.
• Experience supporting FAT/SAT, commissioning, and qualification activities.
• Strong technical writing and documentation skills.
• Ability to work with Engineering, Quality, Manufacturing, and Validation teams.

Responsibilities

• Lead validation activities in GMP-regulated environments.
• Develop and execute IQ, OQ, and PQ protocols and reports.
• Validate equipment, facilities, utilities, and processes.
• Ensure compliance with GMP, GxP, and FDA regulations.
• Manage deviations, CAPA, change controls, and risk assessments.
• Support FAT/SAT, commissioning, and qualification activities.
• Prepare technical write-ups and maintain thorough documentation.
• Collaborate with Engineering, Quality, Manufacturing, and Validation teams.

Skills

Validation experience

IQ/OQ/PQ

GMP/GxP/FDA knowledge

Protocols & reports

Deviation & CAPA

FAT/SAT & commissioning

Technical writing

Cross-functional collaboration

Job description

Job summary:

We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment.

Roles and Responsibilities:

• 10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
• Hands-on experience with IQ, OQ, and PQ.
• Experience with equipment, facility, utility, or process validation.
• Strong knowledge of GMP, GxP, and FDA regulations.
• Experience developing and executing validation protocols and reports.
• Experience with deviations, CAPA, change controls, and risk assessments.
• Experience supporting FAT/SAT, commissioning, and qualification activities.
• Strong technical writing and documentation skills.
• Ability to work with Engineering, Quality, Manufacturing, and Validation teams.