Quality Assurance Validation Engineer

United Pharma; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma in the United States is seeking a Quality Assurance Validation Engineer to support GMP validation across facilities, utilities, systems, and equipment in pharmaceutical/biotech environments. The role provides QA oversight for validation and CSV, collaborating with Validation, Metrology, Automation, QC and business system owners to ensure regulatory compliance and data integrity.

Responsibilities include leading risk-based validation activities, reviewing deliverables, and ensuring

Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Computer Science, or related discipline.
• Minimum 3+ years of validation experience in the pharmaceutical, biologics, biotechnology, or medical device industry.
• 3+ years with facility startups, FAT/SAT, commissioning, qualification documentation.
• Hands-on experience with validation protocols, project plans, data analysis, final reports, and project closeout.
• Experience in asset management and NIST traceability to standards.
• Knowledge of equipment validation, computer system validation, data integrity, and quality systems.
• Strong technical writing, communication, problem-solving, and cross-functional collaboration skills.

Responsibilities

• Provide QA oversight for GMP validation activities using a risk-based approach to ensure compliance and timely project execution.
• Support the complete validation lifecycle for facilities, utilities, equipment, instruments, and computer systems.
• Review and approve validation procedures, project plans, deviations, CAPAs, change controls, and related quality documentation.
• Support equipment qualification, computer system validation, cleaning validation, and data integrity initiatives.
• Collaborate with Metrology, Automation, Quality Control, and technical teams to maintain validated systems and resolve equipment or system failures.
• Develop and maintain SOPs, validation protocols, final reports, risk assessments, and supporting documentation.
• Participate in facility startup, FAT/SAT, commissioning, qualification, audits, inspections, and remediation activities.

Skills

Validation expertise

GMP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Chemical Engineering

Bachelor's degree in Computer Science

Job description

We are seeking a Quality Assurance Validation Engineer to support GMP validation activities across facilities, utilities, systems, and equipment within a pharmaceutical or biotechnology environment. This role will provide QA oversight for validation and computer system validation (CSV), working closely with Validation, Metrology, Automation, Quality Control, and Business System Owners to ensure regulatory compliance, data integrity, and timely completion of validation deliverables.

Responsibilities:

• Provide QA oversight for GMP validation activities using a risk-based approach to ensure compliance and timely project execution.
• Support the complete validation lifecycle for facilities, utilities, equipment, instruments, and computer systems.
• Review and approve validation procedures, project plans, deviations, CAPAs, change controls, and related quality documentation.
• Support equipment qualification, computer system validation, cleaning validation, and data integrity initiatives.
• Collaborate with Metrology, Automation, Quality Control, and technical teams to maintain validated systems and resolve equipment or system failures.
• Develop and maintain SOPs, validation protocols, final reports, risk assessments, and supporting documentation.
• Participate in facility startup, FAT/SAT, commissioning, qualification, audits, inspections, and remediation activities.

Skills and Qualifications:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Computer Science, or a related scientific or technical discipline.
• Minimum 3+ years of validation experience in the pharmaceutical, biologics, biotechnology, or medical device industry.
• At least 3 years of experience with facility startups, FAT/SAT, commissioning, qualification, and associated documentation.
• Hands‑on experience with validation protocols, project plans, data analysis, final reports, and project closeout.
• Experience in asset management and NIST traceability to standards.
• Knowledge of equipment validation, computer system validation, data integrity, and quality systems.
• Strong technical writing, communication, problem‑solving, and cross‑functional collaboration skills.