About this role
<p> </p> <p>At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? </p> <p> </p> <p>There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. </p> <p> </p> <p>We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. </p><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H4 style="font-size:1.0em;margin:0.0px"><b>Job Summary</b></H4> </div><div><p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">This position is responsible for providing Design Verification & Validation for device (Include Software ,Electronics, Mechanical) , Also on computer system validation activities for Research and Development Division and Manufacturing Division in accordance with technical document creation as per the 13485-quality management system.</span></p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">This is a key technical role responsible for the Medical Device Verification and Validation also responsible for Computer System Validation activities , consists of Test planning ,Design and development of Test cases & Test Scripts , Creation of Test Protocols , Execution of Test case, Scripts , Protocols , VMP,RA,IQ,OQ,PQ,VSR,TM and reporting of the NPI and Sustenance products brings quick and innovative implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local and global business.</span></p> <p style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">The role involves hands-on work in the areas of Medical Devices, Software Verification and Validation and Computer System Validation.</span></p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Essential Duties and Responsibilities</b></H2> </div><div><ul> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Responsible for study and understanding the Software Engineer System, Manufacturing software Topology from verification and validation point of view.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Responsible for driving the End-to-End Verification and Validation phase activities includes Test planning ,Design and development of Test cases & Test Scripts (White box) , reviews ,Create and review of Test Protocols , Execution of Test case, Scripts , Protocols and reporting of the NPI and Sustenance products ( Device and System software)</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Supports continuous product improvement through detailed Test and verification activities and identify the failure before the milestone release do the failure analysis for non-conformances, and investigates, communicate with the developers and implements effective and compliant solutions for product corrections from the quality point of view with remediation action plans, and for corrective and preventive actions (CAPA Program).</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Supports on product efficiency and compliance effectiveness through the development and implementation of Device and software verification and validation plans and the development of detailed product process flow diagrams that describe critical interdependencies with respect to product inputs, outputs, risks and impacts as per process and product realization.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) scripts , Trace Matrix and Validation Summary Report in accordance with the global Computer System Validation procedure.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Responsible for All Verification and Validation deliverables , Computer System Validation deliverables of NPI and Sustenance projects.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Effectively interact with the cross functional teams like Design and Development , Quality , Regulatory and Compliance teams.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Additional Responsibilities</b></H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Education</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif;text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Bachelor's in Electronics and Communication or Computer Science background </span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Work Experience</b></H2> </div><div><ul> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Minimum of 3-year experience working in a medical or any regulated industry.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Ability to communicate effectively in English (both written and oral).</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.</span></li> <li style="text-align:justify"><span style="font-family:arial, helvetica, sans-serif">Certification on Azure DevOps or any relevant tool and Lean or Safe Agile Is preferable.</span></li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Preferred Knowledge, Skills and Abilities</b></H2> </div><div><ul> <li>CSV</li> <li>Azure DEVOPS</li> <li>Modern Requirement (preferrable)</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>License and Certifications</b></H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Travel Requirements</b></H2> </div><div><div>10%: Up to 26 business days per year</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Physical Requirements</b></H2> </div><div><div>Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Additional Requirements</b></H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>What We Offer</b></H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Shift</b></H2> </div><div></div></div></div><p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p>West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to <a href="mailto:[email protected]">[email protected]</a>. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.</p>