Validation Engineer

Job Title: Validation Engineer Employment Type: Contract Industry: Pharmaceutical Job Summary: We are seeking a highly skilled Validation Engineer to join our team in the pharmaceutical industry. In this role, you will be responsible for ensuring that all processes, equipment, systems, and software used in drug production and manufacturing meet the required standards for quality, safety, and compliance. You will develop and execute validation protocols, perform risk assessments, and ensure all validation activities are in accordance with FDA, cGMP, and other relevant regulatory requirements. Key Responsibilities: Develop, write, and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, utilities, processes, and computer systems. Conduct risk assessments to identify critical parameters and ensure proper validation of equipment and processes. Support the qualification and validation of cleanrooms, HVAC systems, water systems (WFI, purified water), sterilizers, and other critical utilities. Perform validation of automated control systems and software, including CSV (Computer System Validation). Ensure all validation documentation complies with FDA regulations, cGMP standards, and internal quality systems. Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to implement validation activities and corrective actions. Investigate validation deviations and non-conformances, providing technical input for root cause analysis and recommending corrective and preventive actions. Maintain and update validation master plans, SOPs, and other validation-related documents. Participate in audits and inspections, providing validation expertise and support. Stay up-to-date with regulatory changes, technological advancements, and industry best practices related to validation in the pharmaceutical industry. Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related field. 3-5 years of experience as a Validation Engineer in the pharmaceutical or biotech industry. In-depth knowledge of FDA regulations, cGMP, and pharmaceutical validation processes. Experience with IQ/OQ/PQ protocols and validation of equipment, processes, utilities, and software. Strong understanding of CSV (Computer System Validation) and GAMP 5 guidelines. Excellent problem-solving and troubleshooting skills. Strong attention to detail and documentation skills. Ability to work in a fast-paced environment and manage multiple projects simultaneously. Strong communication and interpersonal skills to collaborate with cross-functional teams. Preferred Qualifications: Experience with validation of aseptic processing, sterile manufacturing, or biopharmaceutical systems. Certification in Validation or Regulatory Affairs. Familiarity with Six Sigma or Lean Manufacturing methodologies. Job Type: Contract Pay: $35.00 - $45.00 per hour Expected hours: 8 per week Schedule: 8 hour shift Work Location: In person