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

  • 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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
CQV Engineer Pharmaceutical Quality Systems

Verista

Posted 2 days ago

VIEW JOBS 10/26/2021 12:00:00 AM 2022-01-24T00:00 <p><strong>Ask About our Hiring Bonus for Candidates with 2 or more years of Pharmaceutical Manufacturing Experience Hired between 10/1/2021 and 12/31/2021!</strong></p><p><strong>Who are we</strong>:<br></p> <p>Looking for an exciting opportunity at a fast growing, employee-oriented company?Verista’s 500+ experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.</p> <p>Verista’s experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, we’re uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.</p> <p>Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day. </p> <p>We deliver solutions that are right the first time. </p><p><strong>Typical Project Accountabilities Include:</strong><br></p><ul> <li>Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.</li> <li>Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.</li> <li>Verify system drawings including ability to review and as-build P&amp;IDs and I&amp;C drawings as well as verifying electrical schematics with electrical engineering support.</li> <li>Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.</li> <li>Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope</li> <li>This specific opportunity will be focused in the area of Quality system management for large scale capital projects.</li> </ul><p><strong>Requirements</strong></p><ul><li>A minimum of a bachelor’s degree in an Engineering or Scientific degree</li></ul> <p><strong>Preferred: </strong></p> <ul> <li>3+ years’ experience in GMP regulated environment</li> <li>Requires prior experience in pharmaceutical quality systems. This role will be responsible for execution of operational activities related to capital equipment projects with a workstream breakdown of key quality systems activities including Vendor Management, Batch Release, Deviation and Change Management, Validation and Qualification.</li> <li>Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)</li> <li>Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls</li> <li>Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment</li> <li>ASTM-E2500</li> </ul><p><strong>Benefits</strong></p><p>Because employees are the key to our success, Verista offers strong benefits and incentives including:<br></p><ul> <li>Health, Dental, and Vision Insurance </li> <li>401(k) Retirement Plan with a company match </li> <li>Paid Time Off Pay </li> <li>Tuition Reimbursement</li> <li>9 Company Paid Holidays</li> <li>Paid Long Term &amp; Short Term Disability Insurance</li> <li>Training and Development</li> <li>Paid Maternity Leave and Parental Leave</li> <li>Travel Bonus</li> <li>Employee Referral Program</li> <li>Tuition Reimbursement</li> <li>Marriage Leave</li> <li>Bereavement</li> </ul><p>*Verista is an Equal Opportunity Employer</p> Verista Swiftwater PA

CQV Engineer - Sterilization Experience

Jacobs Engineering Group Inc.