Job Description
We are seeking a highly motivated Validation Engineer to support validation activities within regulated industries such as Pharmaceuticals, Biotechnology, Medical Devices, Chemicals, or Food Manufacturing . The Validation Engineer will ensure equipment, systems, and processes meet regulatory requirements and function reliably to maintain product quality and patient safety.
Key Responsibilities
- Plan, develop, and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, facilities, and manufacturing systems.
- Support validation of laboratory instruments, production equipment, cleaning processes, and computerized systems.
- Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory guidelines
- Draft and review validation documentation, including protocols, reports, SOPs, and risk assessments.
- Perform troubleshooting and root cause analysis for validation or equipment-related deviations.
- Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, Laboratory) to support project deliverables.
- Participate in change control, CAPA, and continuous improvement initiatives.
- Maintain accurate records and ensure documentation is audit-ready at all times.
Qualifications : Qualifications
Bachelor's degree in Engineering, Life Sciences, or related field5+ years of experience in validation within pharmaceutical, biotechnology, or related regulated industry.Hands-on experience with validation of manufacturing equipment, laboratory instruments, and / or computerized systems.Strong knowledge of GMP, GLP, and regulatory guidelinesExcellent analytical, organizational, and technical writing skills.Ability to work independently and in cross-functional teams.Preferred Skills
Experience with cleaning validation, sterilization, utilities (HVAC, water, compressed gases)Familiarity with data integrity and 21 CFR Part 11 complianceKnowledge of risk-based validation approaches (e.g., ASTM E2500).Additional Information
All your information will be kept confidential according to EEO guidelines.
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