Sr. Validation Engineer

• Develop Standard Operating Procedures (SOPs) for Operation, Maintenance, and Calibration of equipment or processes.
• Develop user requirement specifications (URS), Technical Specifications (TS), Functional Risk Assessments (FRA), Gap Assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for pharmaceutical / Bio-medical / Medical device client processes, CSV, facilities, laboratory, and manufacturing equipment.
• Prepare validation summary reports for executed protocols.
• Develop trends, process optimization techniques, layout designs, warehouse temp/humidity mapping studies, and equipment upgrade testing protocols.
• Conduct GAP assessments, develop audit remediation plans, etc.

Qualifications And Experience:-

• Bachelor’s Degree (Mechanical, Chemical, Electrical or related).
• 7+ years of life-sciences (Pharma/Biotech/Medical Device) industry experience.

Required Skills:-

• Experience in pharmaceutical, biopharmaceutical, and/or medical devices environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment.
• Direct validation/quality experience with pharmaceutical, bio-pharmaceutical, or medical devices processes including the development of procedures, validation lifecycle documents, and Computer System Validation (CSV).
• Experience in regulatory inspections and knowledge in current industry standards and regulatory trends as they pertain to validation of pharmaceutical, biopharmaceutical, and/or medical devices processes and data integrity.
• Systems knowledge and experience with Standard Operating Procedures (SOPs), Computerized Systems, Deviations, CAPA, Audits and Change Control processes.
• Ability to understand complex mechanical systems and basic automated controls.
• Highly effective verbal and written English skills, including technical writing.
• Proficient in Microsoft Office, particularly Microsoft Word, Excel, PowerPoint, Project, and Outlook.

Location:-

• Chennai, India.

Company Overview:-

Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world’s leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.