Jr. CQV Engineer - Sterilization Experience

Jacobs Engineering Group Inc. Swiftwater , PA 18370

Posted 2 months ago

Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference.

As a Commissioning, Qualification, and Validation (CQV) Engineer, you'll join our collaborative team providing CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate CQV Engineer who is driven by collaboration, exceeding expectations, and challenging the status quo.

You'll be accountable for developing CQV planning documents to manage CQV projects, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CQV summary reports, and starting up equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You'll also be accountable for reading and verifying facility and equipment drawing (e.g., P&IDs, AF&IDs, etc.), developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.

Bring your curiosity, talent for multi-taskingand collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.

  • Bachelor's degree in Mechanical, Chemical, or Electrical Engineering or equivalent

  • Commissioning, Qualification, and Validation (CQV) experience in the Life Sciences industry

  • Experience executing annual sterilization requalification programs, annual decontamination requalification programs, and supplemental decontamination support for the decontamination programs while following and being compliant with department and site sterilization related procedures.

  • Understanding of Good Manufacturing Practices (GMPs)

  • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project

  • Flexibility and willingness to travel and work at various clients' locations

Ideally, you'll also have:

  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations

  • Knowledge of industry guidance:

  • ISPE Baseline Guide 5 Commissioning and Qualification

  • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

  • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

  • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011

  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

  • Six Sigma Certification

Please note: CQV work occurs at the client site

#LifeSciences, #Bio/Pharma, #EPCMV

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CQV Engineer Sterilization Experience

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VIEW JOBS 9/10/2021 12:00:00 AM 2021-12-09T00:00 Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference. As a Commissioning, Qualification, and Validation (CQV) Engineer, you'll join our collaborative team providing CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate CQV Engineer who is driven by collaboration, exceeding expectations, and challenging the status quo. You'll be accountable for developing CQV planning documents to manage CQV projects, generating and executing CQV protocols using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CQV summary reports, and starting up equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You'll also be accountable for reading and verifying facility and equipment drawing (e.g., P&IDs, AF&IDs, etc.), developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation. Bring your curiosity, talent for multi-tasking and collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together. * Bachelor's degree in Mechanical, Chemical, or Electrical Engineering or equivalent * Commissioning, Qualification, and Validation (CQV) experience in the Life Sciences industry * Experience executing annual sterilization requalification programs, annual decontamination requalification programs, and supplemental decontamination support for the decontamination programs while following and being compliant with department and site sterilization related procedures. * Understanding of Good Manufacturing Practices (GMPs) * Proficient with Microsoft Office - Word, Excel, PowerPoint, Project * Flexibility and willingness to travel and work at various clients' locations Ideally, you'll also have: * Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations * Knowledge of industry guidance: * ISPE Baseline Guide 5 Commissioning and Qualification * ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems * ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment * SPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 * ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011 * Six Sigma Certification Please note: CQV work occurs at the client site #LifeSciences, #Bio/Pharma, #EPCMV Jacobs Engineering Group Inc. Swiftwater PA

Jr. CQV Engineer - Sterilization Experience

Jacobs Engineering Group Inc.