Engineer II, Manufacturing

<p><b>About This Role</b><br />As an Engineer II in Manufacturing, you will be a pivotal member of our dynamic drug substance manufacturing team. Your primary role involves providing engineering technical support and troubleshooting for manufacturing equipment, ensuring smooth and efficient operations. You will actively participate in new product tech transfer activities, contributing to our continuous improvement initiatives. This position allows you to manage small engineering projects under supervision, working closely with contractors and multi-functional teams to enhance existing processes. Your efforts will directly support the design, specification, and installation of new equipment, as well as modifications to existing systems. By executing and tracking validation activities related to manufacturing equipment, you will play a crucial role in maintaining our high standards of quality and compliance.</p><p></p><p><b>What You’ll Do:</b></p><ul><li><p>Provide engineering technical support and troubleshooting for drug substance manufacturing equipment.</p></li><li><p>Support new product tech transfer activities and participate in investigations.</p></li><li><p>Collaborate with contractors and provide direction to enhance processes.</p></li><li><p>Implement change and improve existing manufacturing processes.</p></li><li><p>Design and develop validation protocols, focusing on equipment and automation design/modifications.</p></li><li><p>Coordinate equipment and cleaning validation protocols for specific areas.</p></li><li><p>Develop and support equipment commissioning and qualification activities.</p></li><li><p>Attend FAT for new equipment systems as a validation subject matter expert.</p></li><li><p>Maintain personal training and track goal development and compliance workflows.</p></li><li><p>Contribute to cross-functional teams and support design and installation efforts.</p></li></ul><p></p><p><b>Who You Are</b><br />You are a detail-oriented and proactive individual with a strong passion for engineering in a manufacturing environment. Your ability to collaborate with diverse teams and communicate effectively sets you apart. You thrive in dynamic settings and are eager to learn and grow in your role. Your commitment to maintaining high standards and compliance aligns with our organizational values. Your analytical mindset helps you navigate complex problems, and your dedication to continuous improvement drives your success.</p><p></p><p><b>Required Skills</b></p><ul><li><p>BS in Engineering,</p></li><li><p>0-2 years of experience in GMP validation, manufacturing, engineering, or facilities in a pharmaceutical environment.</p></li><li><p>Knowledge of GMPs and EMEA regulations.</p></li><li><p>Experience in cleaning and equipment validation philosophy.</p></li></ul><p></p><p><b>Preferred Skills</b></p><ul><li><p>Excellent oral and written communication skills.</p></li><li><p>Experience in a pharmaceutical or biotech manufacturing environment.</p></li><li><p>Ability to work off-hours, extended shifts, and weekends as needed.</p></li><li><p>Demonstrated experience in managing small engineering projects.</p></li></ul><p></p><p style="text-align:inherit"><br /> </p>Job Level: Professional<p style="text-align:left"><br /><b>Additional Information</b></p><p style="text-align:inherit"></p>The base compensation range for this role is: $65,000.00-$85,000.00<div><p style="text-align:left"><br /><span>Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &amp; experience, job location, and internal equity.</span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families <i>physical, financial, emotional,</i> and <i>social well-being</i>; including, but not limited to:</span></p><ul><li><span>Medical, Dental, Vision, &amp; Life insurances</span></li><li><span>Fitness &amp; Wellness programs including a fitness reimbursement </span></li><li><span>Short- and Long-Term Disability insurance</span></li><li><span>A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)</span></li><li><span>Up to 12 company paid holidays &#43; 3 paid days off for Personal Significance </span></li><li><span>80 hours of sick time per calendar year</span></li><li><span>Paid Maternity and Parental Leave benefit </span></li><li><span>401(k) program participation with company matched contributions</span></li><li><span>Employee stock purchase plan </span></li><li><span>Tuition reimbursement of up to $10,000 per calendar year </span></li><li><span><span>Employee Resource Groups participation</span></span></li></ul><p style="text-align:inherit"></p></div><div><p style="text-align:left"><b>Why Biogen?</b></p><p style="text-align:left">We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.</p><p style="text-align:inherit"></p><p style="text-align:left">At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.<span> </span><a href="https://nam12.safelinks.protection.outlook.com/?url&#61;https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&amp;data&#61;05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata&#61;p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&amp;reserved&#61;0" target="_blank">Read on</a><span> </span>to learn more about our DE&amp;I efforts.</p><p style="text-align:inherit"></p><p style="text-align:left">All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.</p></div>