Validation Engineer

Commissioning Partners LLC.; New Jersey; Sur place; USD 80 000 - 120 000; Plein temps

Résumé du poste

Commissioning Partners LLC. seeks a Validation Engineer to support commissioning, qualification and validation activities for pharma/biotech facilities and systems in New Jersey.

The role involves developing and executing IQ/OQ/PQ protocols, reviewing URS/FRS, and ensuring data integrity and regulatory compliance. The candidate will coordinate with Engineering, Manufacturing, QA, and external vendors, maintain validation documentation, and support audits and inspections as needed.

Qualifications

• 3+ years of experience in pharmaceutical/biotech regulated environments.
• Experience with qualification protocols and GMP documentation.
• Familiarity with cGMP, FDA regulations, and data-integrity principles.

Responsabilités

• Develop, review, and execute IQ/OQ/PQ and equipment qualification activities.
• Support commissioning and qualification of manufacturing equipment and facility systems.
• Prepare URS/FRS/Design Specifications and risk assessments.
• Execute testing, document results, and resolve protocol exceptions.
• Review P&IDs, drawings, manuals, and vendor docs; coordinate with cross-functional teams.
• Ensure activities comply with GMP, FDA, and SOPs.

Connaissances

IQ/OQ/PQ

GMP documentation

CAPA

Change control

Risk assessment

Engineering drawings

Technical writing

Communication

Formation

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related field

Outils

Validation management systems

Description du poste

We are seeking a Validation Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotech manufacturing facilities, equipment, utilities, and computerized systems. The ideal candidate will have experience developing and executing validation protocols, supporting equipment qualification, investigating deviations, and ensuring compliance with GMP, FDA, and applicable regulatory requirements.

Key Responsibilities

• Develop, review, and execute validation and qualification protocols including IQ, OQ, PQ, and equipment/system qualification activities.
• Support commissioning and qualification of manufacturing equipment, facility systems, clean utilities, HVAC, process equipment, and laboratory systems.
• Prepare and review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, risk assessments, and validation plans.
• Execute installation, operational, and performance qualification activities in accordance with approved protocols and procedures.
• Perform validation testing, document test results, identify discrepancies, and support resolution of protocol exceptions.
• Support cleaning validation, process validation, equipment validation, utility qualification, and environmental monitoring qualification activities as applicable.
• Investigate deviations, validation discrepancies, and out-of-specification results and support root-cause analysis and corrective actions.
• Support change-control activities and evaluate the validation impact of proposed equipment, process, facility, and system changes.
• Review equipment and system documentation including P&IDs, electrical drawings, manuals, specifications, and vendor documentation.
• Coordinate with Engineering, Manufacturing, Quality Assurance, Maintenance, Automation, Facilities, and external vendors during qualification activities.
• Prepare validation summary reports, test records, traceability matrices, qualification packages, and other GMP documentation.
• Ensure validation activities are executed in accordance with cGMP, FDA, GAMP 5, SOPs, data-integrity requirements, and site procedures.
• Support audit and inspection readiness by maintaining complete, accurate, and traceable validation documentation.
• Participate in commissioning, startup, troubleshooting, and qualification of new and modified equipment and systems.
• Maintain validation schedules, track deliverables, and communicate project status, risks, and open items to project stakeholders.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical field.
• 3+ years of experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Experience with equipment qualification, commissioning, validation protocols, and GMP documentation.
• Working knowledge of IQ/OQ/PQ, deviations, CAPA, change control, and risk assessment.
• Familiarity with cGMP, FDA regulations, GAMP 5, and data-integrity principles.
• Ability to interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
• Strong technical writing, communication, troubleshooting, and organizational skills.

Preferred Qualifications

• Experience with process equipment, clean utilities, HVAC, automation, or computerized systems validation.
• Experience with electronic documentation and validation management systems.
• Knowledge of ASTM, ISPE, FDA, and other applicable industry standards.
• Experience supporting regulatory inspections and client audits.