Validation Engineer

Job Description

Job Description

We are seeking a highly motivated Validation Engineer to join our team in ensuring compliance with cGMP regulations and supporting the validation of pharmaceutical equipment, systems, and processes. This role plays a critical part in maintaining product quality, patient safety, and regulatory compliance.

Key Responsibilities

• Develop, execute, and review validation protocols (IQ, OQ, PQ, CSV, and process validation).

• Ensure equipment, utilities, facilities, and computerized systems comply with FDA, EMA, and other global regulatory requirements.

• Perform risk assessments, deviation investigations, and CAPA implementation related to validation activities.

• Support change control activities by assessing validation impact and preparing required documentation.

• Collaborate with Quality Assurance, Engineering, Manufacturing, and R&D teams to drive continuous improvements.

• Maintain validation master plans (VMP) and ensure periodic reviews are completed.

• Provide technical support during regulatory inspections and audits.

Qualifications & Skills

• Bachelor’s degree in Engineering, Pharmacy, Biotechnology, or related field.

• 2–5 years of experience in validation within the pharmaceutical or biotech industry.

• Strong knowledge of cGMP, FDA, EMA, ICH, and GAMP guidelines.

• Hands-on experience with equipment qualification, process validation, and cleaning validation.

• Excellent documentation, analytical, and problem-solving skills.

• Ability to manage multiple projects and work cross-functionally in a fast-paced environment.

Thanks

Suchi

[email protected]

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Company Description

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.