Validation Specialist

Validation Specialist

The Validation Specialist develops, executes, and maintains validation and qualification programs to ensure manufacturing equipment, utilities, processes, and systems meet FDA, cGMP, and internal standards. This role supports sterile injectable manufacturing operations, safeguards product quality, and helps maintain regulatory compliance and inspection readiness in a highly controlled environment.

Responsibilities

• Develop, execute, and maintain validation and qualification programs for manufacturing equipment, utilities, processes, and systems.
• Perform equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing systems and production equipment.
• Create, update, and control validation documentation, including Validation Master Plans, User Requirements Specifications, validation protocols, and final summary reports.
• Support the qualification of critical utilities such as HVAC, Water for Injection (WFI), purified water, clean steam, compressed air, and environmental monitoring systems.
• Execute process validations, media fills, cleaning validations, and requalification activities to ensure ongoing compliance and process robustness.
• Conduct risk assessments related to validation activities and document risk-based rationales for validation strategies.
• Investigate validation deviations, identify root causes, and implement corrective and preventive actions.
• Support and evaluate change controls to ensure validated states are maintained when equipment, utilities, or processes change.
• Review validation data for accuracy, completeness, and compliance with applicable regulations and internal procedures.
• Ensure documentation practices align with data integrity principles and meet FDA, cGMP, and company standards.
• Collaborate closely with Engineering, Production, Quality Control, Microbiology, and Quality Assurance teams to plan and execute validation activities.
• Support commissioning activities for new or modified equipment and systems, ensuring smooth transition into validated operation.
• Participate in and support regulatory inspections and internal audits by providing validation documentation and subject matter expertise.
• Contribute to continuous improvement initiatives related to validation, qualification, and overall quality systems.
• Ensure ongoing compliance with FDA regulations, cGMP requirements, data integrity standards, and internal procedures in all validation activities.

Essential Skills

• Bachelor's degree in Chemistry, Microbiology, Biotechnology, Engineering, Pharmacy, or a related scientific field.
• At least 5 years of validation experience within pharmaceutical manufacturing.
• Hands-on experience supporting sterile injectable manufacturing environments.
• Demonstrated experience with equipment, utility, process, and cleaning validation.
• Strong understanding of FDA cGMP regulations and 21 CFR Parts 210 and 211.
• Working knowledge of Annex 1 sterile manufacturing requirements.
• Experience conducting risk assessments, deviation investigations, and managing change controls.
• Proficiency in developing and executing IQ/OQ/PQ protocols and related validation documentation.
• Knowledge of data integrity principles, including ALCOA+.
• Experience in quality assurance and validation activities within a regulated environment.
• Strong technical writing skills for authoring protocols, reports, and supporting documentation.
• Strong analytical and problem-solving skills with attention to detail.

Additional Skills & Qualifications

• Experience in Chemistry, Microbiology, Biotechnology, or related scientific disciplines.
• Experience working with sterile manufacturing processes and media fills.
• Exposure to Computer System Validation (CSV) in a pharmaceutical or cGMP environment.
• Familiarity with cleaning validation principles and practices.
• Experience collaborating with cross-functional teams including Engineering, Production, Quality Control, Microbiology, and Quality Assurance.
• Ability to interpret and apply regulatory guidance and industry best practices to validation strategies.

Work Environment

The role operates within a cGMP-compliant pharmaceutical manufacturing environment, including clean room areas dedicated to sterile injectable production. Work is performed in highly controlled, regulated spaces where adherence to aseptic techniques, environmental monitoring, and strict documentation practices is essential. The position involves close collaboration with cross-functional teams and regular interaction with production equipment, utilities, and quality systems in a clean room and broader cGMP facility.

Job Type & Location

This is a Contract to Hire position based out of Boca Raton, FL.

Pay and Benefits

The pay range for this position is $36.06 - $45.67/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).

Workplace Type

This is a fully onsite position in Boca Raton, FL.

Application Deadline

This position is anticipated to close on Aug 21, 2026.