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Sr. Validation Engineer

5.00 to 0.00 Years   Chennai   09 Jun, 2021
Barry Wehmiller international
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other Software,Testing
EmploymentTypeFull-time

Job Description

About Us: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.Basic Qualifications:

  • Bachelors Degree (Mechanical, Chemical or related).
  • >5 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 knowledgeable 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.
What will you do
  • 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.
Location:
  • Design Group - Chennai
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. Company:Design Group India,

Keyskills :
validationdebuggingtest casescustomer relationscomputer system validationstandard operating procedurescontinuous improvement facilitationlife sciencescontrol systemchange controlintel

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