Validation Specialist

EPM Scientific; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

EPM Scientific seeks a Validation Specialist/Engineer to support qualification, validation, and lifecycle management at a sterile injectable manufacturing facility in Florida. The role ensures equipment, utilities, facilities, and processes stay compliant with cGMP and regulatory requirements while enabling site growth and readiness.

The ideal candidate has a strong background in validation, GMP facilities, and hands-on IQ/OQ/PQ experience, with collaborative cross-functional skills and

Qualifications

• Bachelor's degree in a relevant discipline.
• 5+ years of validation experience in pharmaceutical manufacturing.
• Experience supporting GMP-regulated manufacturing facilities.

Responsibilities

• Execute and maintain qualification and validation programs across manufacturing, utilities, facilities, and laboratory systems.
• Author, review, and execute validation protocols, reports, and documentation.
• Support equipment qualification activities including IQ, OQ, PQ, and requalification programs.
• Perform validation activities for manufacturing equipment, process systems, and utility systems.
• Support process validation, media fills, and cleaning validation programs.
• Conduct risk assessments and validation impact assessments related to change controls.
• Investigate validation-related deviations and implement corrective actions.
• Review validation data and prepare summary reports.
• Maintain validation schedules and support ongoing compliance activities.
• Partner with Engineering, Manufacturing, Quality, Microbiology, and Quality Control teams.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure validation documentation remains inspection-ready and compliant with cGMP requirements.

Skills

IQ/OQ/PQ execution

Technical writing

Regulatory compliance

Cross-functional collaboration

Change controls

Validation lifecycle

GMP knowledge

Education

Bachelor's degree in Engineering, Chemistry, Pharmacy, Biotechnology, Microbiology, Life Sciences, or related

Job description

Validation Specialist / Validation Engineer

A growing pharmaceutical manufacturer is seeking a Validation Specialist / Validation Engineer to support qualification, validation, and lifecycle management activities across a sterile injectable manufacturing facility.

This individual will play a key role in ensuring manufacturing equipment, utilities, facilities, processes, and systems remain compliant with cGMP and regulatory requirements while supporting ongoing site growth and operational readiness.

Key Responsibilities

• Execute and maintain qualification and validation programs across manufacturing, utilities, facilities, and laboratory systems
• Author, review, and execute validation protocols, reports, and associated documentation
• Support equipment qualification activities including IQ, OQ, PQ, and requalification programs
• Perform validation activities for manufacturing equipment, process systems, and utility systems
• Support process validation, media fills, and cleaning validation programs
• Conduct risk assessments and validation impact assessments related to change controls
• Investigate validation-related deviations and implement corrective actions
• Review validation data and prepare summary reports
• Maintain validation schedules and support ongoing compliance activities
• Partner closely with Engineering, Manufacturing, Quality, Microbiology, and Quality Control teams
• Support internal audits, customer audits, and regulatory inspections
• Ensure validation documentation remains inspection-ready and compliant with cGMP requirements

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmacy, Biotechnology, Microbiology, Life Sciences, or a related discipline
• 5+ years of validation experience within pharmaceutical manufacturing
• Experience supporting GMP-regulated manufacturing facilities
• Hands-on experience executing IQ/OQ/PQ activities
• Strong technical writing and documentation skills
• Experience supporting investigations, deviations, and change controls
• Strong understanding of validation lifecycle principles and regulatory expectations
• Excellent communication and cross-functional collaboration skills

Preferred

• Process validation experience
• Utility qualification experience (WFI, Purified Water, HVAC, Clean Steam, Compressed Air)
• Knowledge of FDA regulations, cGMP, Annex 1, and Data Integrity requirements
• Experience supporting regulatory inspections and audit readiness initiatives

Ideal Background

• Validation Specialist
• Validation Engineer
• Senior Validation Specialist
• Commissioning & Qualification (CQV) Engineer
• Process Validation Engineer
• Equipment Validation Engineer
• Qualification Engineer
• Validation Scientist
• Manufacturing Validation Specialist

This opportunity is ideal for a validation professional looking to make a significant impact within a growing sterile pharmaceutical manufacturing environment while supporting critical compliance, quality, and operational initiatives.