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;line-height:normal;margin:0.0cm;font-size:12.0pt;font-family:'Times New Roman', serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">In this fully onsite role, the Manufacturing Quality Engineer will own all qualiy activities at one of the manufacturing sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to the production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. </span><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Additionally, this role will identify and implement improvements to the production processes. </span><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production. </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="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Responsible to write, review and approve pilot documents (including reports).</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Write and approve various department and production procedures and forms.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Lead investigation processes for deviations and nonconformities in production and create analysis reports.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Responsible to train the sub-contractors according to QA procedures and VoE.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support special processes such as sorting or rework in production.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Own all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Manage production related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Provide Quality oversight of validation activities and processes.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Lead pilot processes that include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.</span></li> <li style="line-height:normal;font-size:12.0pt;font-family:arial, helvetica, sans-serif;color:black"><span style="font-size:10.0pt;font-family:arial, helvetica, sans-serif">Attend production pilot meetings as the MQ focal point.</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>Education</b></H2> </div><div><ul> <li>Bachelor's Degree in Engineering or science related- required</li> <li><span style="font-family:arial, helvetica, sans-serif">Relevant work history and/or experience may be considered in lieu of degree</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>Minimum 3 years of experience in a quality engineering role in a regulated industry, pharmaceutical, or medical device manufacturer- required </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 style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with production processes and process controls</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with sub contractors interface and meeting customer expectations</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Must have effective problem solving and interpersonal skills</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to work independently, multi-task and thrive in fast-paced environment</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Problem solving including root cause failure analysis methods</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 Requirements</b></H2> </div><div><ul> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Minimum 3 years of experience in Medical Device Quality & Production lifecycle</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with production processes and process controls</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with sub contractors interface and meeting customer expectations</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Must have effective problem solving and interpersonal skills</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ability to work independently, multi-task and thrive in fast-paced environment</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Problem solving including root cause failure analysis methods</span></li> </ul></div></div></div><p> </p> <p> </p> <p> </p> <p>West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening. </p> <p> </p> <p>#LI-KR1</p> <p>#LI-onsite</p>