Validation

The Validation Specialist / Validation Engineer is responsible for planning, executing, documenting, and maintaining qualification and validation activities supporting sterile injectable pharmaceutical manufacturing operations.

This role ensures that manufacturing facilities, utilities, equipment, computerized systems, cleaning processes, and manufacturing processes are appropriately qualified and validated in accordance with FDA regulations, current Good Manufacturing Practices (cGMP), applicable industry standards, and established quality procedures.

The successful candidate will work cross-functionally with Quality Assurance, Engineering, Production, Quality Control, Microbiology, and other departments to ensure validation activities are scientifically sound, properly documented, compliant, and inspection-ready.

Department: Quality Assurance

Reports To: Senior Manager, Quality Assurance

Employment Type: Full-Time

Salary Range: $75,000–$95,000, based on experience

Key Responsibilities

• Prepare, review, execute, and maintain validation and qualification documentation, including:
• Validation Master Plans (VMP)
• User Requirement Specifications (URS)
• Design Qualifications (DQ)
• Installation Qualifications (IQ)
• Operational Qualifications (OQ)
• Performance Qualifications (PQ)
• Requalification protocols and reports
• Validation summary reports
• Plan and execute qualification activities for equipment used in sterile injectable manufacturing, including:
• Compounding and formulation vessels
• Isolators and Restricted Access Barrier Systems (RABS)
• Aseptic filling machines
• Vial washers
• Depyrogenation tunnels
• Lyophilizers
• Autoclaves
• Visual inspection equipment
• Packaging equipment
• Support qualification and requalification of critical pharmaceutical utilities and systems, including:
• HVAC systems
• Purified Water (PW)
• Water for Injection (WFI)
• Clean Steam
• Compressed Air
• Nitrogen
• Environmental Monitoring systems
• Execute and/or support process validation activities, including process performance qualification and aseptic process simulation/media fill studies.
• Coordinate and support cleaning validation and cleaning verification activities.
• Develop and execute validation protocols, review test results, and ensure validation activities meet established acceptance criteria.
• Prepare and participate in quality risk assessments using Quality Risk Management principles.
• Review deviations, discrepancies, and validation failures; support investigations and development of appropriate corrective and preventive actions.
• Participate in change control assessments and evaluate the potential validation impact of proposed changes.
• Support equipment commissioning and transition of systems from commissioning into qualification.
• Develop and maintain validation schedules, ensuring required qualification and requalification activities are completed within established timelines.
• Collaborate with Engineering, Production, QC, Microbiology, QA, and other cross-functional teams to resolve technical and validation-related issues.
• Support internal audits, customer audits, regulatory inspections, and other inspection-readiness activities.
• Ensure validation documentation and activities comply with applicable cGMP requirements, FDA regulations, ALCOA principles, Data Integrity expectations, and established procedures.
• Identify opportunities for continuous improvement and contribute to initiatives that improve validation processes, compliance, efficiency, and operational performance.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, Engineering, or a related scientific or technical discipline.
• 5–10 years of relevant validation experience within pharmaceutical manufacturing.
• Hands-on experience supporting sterile injectable pharmaceutical manufacturing is required.
• Demonstrated experience with equipment qualification, utility qualification, process validation, and/or cleaning validation.
• Experience working in regulated pharmaceutical manufacturing environments with strong documentation and compliance requirements.

Knowledge & Skills

Strong knowledge and practical understanding of:

• FDA cGMP regulations
• 21 CFR Parts 210 and 211
• EU GMP Annex 1 and sterile manufacturing requirements
• Equipment Qualification
• Utility Qualification
• Process Validation
• Cleaning Validation
• Aseptic Process Simulation / Media Fill
• Computerized System Validation (CSV) — preferred
• Quality Risk Management and risk assessments
• Deviation investigations
• Change Control
• Data Integrity and ALCOA principles
• Validation lifecycle management

Additional qualifications include:

• Excellent technical writing and documentation skills
• Strong analytical and problem-solving abilities
• Ability to interpret technical data and validation results
• Strong attention to detail and organizational skills
• Ability to manage multiple validation activities and priorities
• Effective written and verbal communication skills
• Ability to work collaboratively in a cross-functional environment
• Ability to support a fast-paced, highly regulated manufacturing environment