Senior Sterile Injectables Validation Specialist

Actalent; Boca Raton (FL); On-site; USD 50,000 - 63,000; Full time

Benefits offered by this job

Medical

Dental and vision

401(k)

Life Insurance

Disability

HSA

Transportation benefits

Employee Assistance Program

PTO/Leave

Job summary

Actalent is seeking a Validation Specialist in Boca Raton, FL to develop, execute, and maintain validation programs ensuring equipment, utilities, processes, and systems meet FDA and cGMP standards.

You will perform IQ/OQ/PQ activities, author validation documents, and support qualification of HVAC and utilities while collaborating with cross-functional teams to ensure inspection readiness.

Qualifications

• Bachelor’ s degree required in a scientific field and 5+ years of pharma validation experience.
• Hands-on experience with sterile injectable manufacturing environments and manufacturing validations.
• Familiarity with FDA cGMP regulations and 21 CFR Parts 210/211.

Responsibilities

• Perform equipment qualification activities, including IQ/OQ/PQ protocols for manufacturing systems and production equipment.
• Develop and maintain validation documentation such as Validation Master Plans, User Requirements, protocols, and final reports.
• Support qualification of critical utilities including HVAC, WFI, purified water, clean steam, compressed air, and environmental monitoring systems.
• Execute process validations, media fills, cleaning validations, and requalification activities.
• Conduct risk assessments, investigate validation deviations, and support change control evaluations.
• Review validation data and ensure accurate, compliant documentation practices.
• Collaborate with Engineering, Production, Quality Control, Microbiology, and Quality Assurance teams.
• Support commissioning, regulatory inspections, internal audits, and continuous improvement initiatives.
• Ensure compliance with FDA regulations, cGMP requirements, data integrity standards, and company procedures.

Skills

Quality assurance

Validation

Sterile manufacturing

Injectable

ALCOA+ principles

21 CFR 210/211

Cleaning validation

Microbiology

Chemistry

Biotechnology

IQ/OQ/PQ

Education

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

Tools

CSV

Job description

Actalent is seeking a Validation Specialist in Boca Raton, FL to develop, execute, and maintain validation programs ensuring equipment, utilities, processes, and systems meet FDA and cGMP standards.

You will perform IQ/OQ/PQ activities, author validation documents, and support qualification of HVAC and utilities while collaborating with cross-functional teams to ensure inspection readiness.