Validation Engineer

Stark Pharma Solutions Inc; City of Rochester (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. in Rochester, NY, is seeking a Validation Engineer to lead equipment qualification, process validation, cleaning validation, utility validation, and CSV in a GMP-regulated environment.

You will ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 while maintaining rigorous technical documentation and cross-functional collaboration. The role covers IQ/OQ/PQ execution, protocol development, risk assessment, deviations handling, audits support, and maintaining

Qualifications

• BS in engineering with 2+ years in pharmaceutical validation.

Responsibilities

• Execute IQ/OQ/PQ for equipment in production and lab settings.
• Develop validation protocols and final reports.
• Support CSV, cleaning validation, utility validation and risk assessments.
• Participate in audits and CAPA investigations.

Skills

Validation experience

IQ/OQ/PQ

Process Validation

FDA regulations

GAMP 5

CAPA & deviations

Cross-functional collaboration

Technical writing

Education

Bachelor's Degree in Mechanical/Biomedical Engineering

Tools

TrackWise

Kneat

Veeva

DeltaV

SCADA

PLC

Job description

Job Title: Validation Engineer

Location: Rochester, NY

Duration: Long Term

Position Overview: We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role will be responsible for equipment qualification, process validation, cleaning validation, utility validation, and computerized system validation while ensuring compliance with FDA regulations, cGMP, GAMP 5, and industry standards. The ideal candidate will possess strong technical documentation skills and collaborate effectively with cross-functional teams to support manufacturing and quality operations.

Key Responsibilities

• Execute Equipment Qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
• Develop, review, execute, and maintain validation protocols, test scripts, and final validation reports.
• Support Process Validation, Cleaning Validation, Utility Validation, and Computer System Validation (CSV) activities.
• Perform risk assessments using FMEA and support validation lifecycle management.
• Ensure validation documentation complies with FDA, cGMP, GAMP 5, 21 CFR Part 11, and company quality standards.
• Investigate validation deviations, support CAPA implementation, and perform root cause analysis.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs teams to execute validation projects.
• Review engineering documentation including URS, FS, DS, SOPs, P&IDs, and equipment specifications.
• Support equipment commissioning, startup, qualification, and process improvement initiatives.
• Maintain Validation Master Plans (VMP), validation schedules, and project documentation.
• Participate in internal audits, customer audits, and regulatory inspections.
• Identify opportunities to improve validation processes, documentation, and compliance activities.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.
• 2+ years of validation experience within the pharmaceutical, biotechnology, or medical device industry.
• Hands-on experience with Equipment Qualification (IQ/OQ/PQ), Process Validation, Cleaning Validation, Utility Validation, or Computer System Validation (CSV).
• Strong understanding of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, and data integrity requirements.
• Experience developing, executing, and reviewing validation protocols and reports.
• Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
• Experience working in GMP-regulated manufacturing environments.
• Strong technical writing, analytical, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.
• Experience with validation management systems such as TrackWise, Kneat, Veeva, DeltaV, SCADA, PLC, or similar platforms is preferred.
• Knowledge of Lean Manufacturing, continuous improvement, and commissioning & qualification (CQV) practices is an added advantage.