GMP Validation Lead - Equipment & CSV

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

Job summary

Creative Solutions Services, LLC is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring compliance with FDA, EMA, and cGMP regulations.

The role collaborates with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams, mentors junior staff,

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, CSV.

Responsibilities

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ) for systems and processes.
• Author, review, and approve validation documentation and risk assessments.
• Execute validation activities for equipment, processes, utilities, and computer systems.
• Support C&Q for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, FDA, EMA, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Skills

GxP knowledge

Regulatory inspections

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ

Process Validation

Equipment Qualification

Cleaning Validation

CSV

Risk Assessments

Change Control & CAPA

GAMP 5

Job description

Creative Solutions Services, LLC is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring compliance with FDA, EMA, and cGMP regulations.

The role collaborates with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams, mentors junior staff,