Job Description
Job Description
We are seeking an experienced Validation Specialist / Validation Engineer to support qualification and validation activities within an FDA-regulated sterile injectable pharmaceutical manufacturing environment. This role is responsible for planning, executing, documenting, and maintaining validation activities to ensure facilities, equipment, utilities, processes, and computerized systems comply with FDA and cGMP requirements.
Responsibilities
- Prepare, execute, review, and maintain validation documentation, including:
- Validation Master Plans (VMP)
- User Requirement Specifications (URS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Requalification protocols
- Perform equipment qualification for sterile injectable manufacturing equipment, including compounding vessels, filling machines, isolators/RABS, vial washers, depyrogenation tunnels, lyophilizers, autoclaves, visual inspection equipment, and packaging systems.
- Support qualification of critical utilities, including HVAC, Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, Nitrogen, and Environmental Monitoring systems.
- Execute process validation, media fill studies, and cleaning validation activities.
- Review validation data, investigate deviations, and prepare validation summary reports.
- Participate in change control assessments and determine validation impact.
- Support equipment commissioning, validation scheduling, and periodic requalification activities.
- Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Microbiology teams.
- Support internal audits, customer audits, and regulatory inspections.
- Ensure compliance with FDA regulations, cGMP, 21 CFR Parts 210 & 211, Annex 1, Data Integrity (ALCOA+), and company procedures.
- Participate in continuous improvement initiatives to enhance validation and compliance programs.
Qualifications
- Bachelor's degree in Engineering, Chemistry, Pharmacy, Biotechnology, Microbiology, or a related scientific discipline.
- 5–10 years of validation experience in pharmaceutical manufacturing.
- Sterile injectable manufacturing experience is required.
- Strong experience with equipment qualification, utility qualification, process validation, and cleaning validation.
- Computer System Validation (CSV) experience is a plus.
- Knowledge of FDA cGMP regulations, 21 CFR Parts 210 & 211, Annex 1, change control, deviation investigations, risk assessments, and data integrity principles.
- Excellent technical writing, documentation, analytical, and problem-solving skills.
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