Manufacturing Process Specialist

About This RoleIn this Parenteral Filling Manufacturing Process Specialist role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.What You’ll DoAuthor manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot recordsmanagement and project execution –participate in projects (simple to moderately complex in nature), facilitating timely execution.Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.Initiate, own, and manage manufacturing focused change controls, CAPAs, investigations, and planned exceptionsThis site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.Who You AreIf you are a highly detailed and focused individual who demonstrates a moderate level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.QualificationsRequired Skills:Bachelor’s degree (Life Sciences or Engineering ) preferred, with 0-1 years of transferrable experienceAssociates Degree or Bioworks Certificate and 2 years of transferrable ExperienceHigh School Diploma (or Equivalent) 4 years of transferrable experiencePreferred SkillsPrior experience supporting Investigations within manufacturing operationsPrior experience in manufacturing – drug product operationsUnderstanding of business processes and roles of cross-functional groups supporting manufacturing operationsRobust understanding of quality and cGMP principlesFundamental knowledge of change control in cGMP environmentIntermediate to advanced skills in Microsoft Office and computer-based quality systemsIntermediate to advanced level of technical writing skillAbility to interpret manufacturing process design documentationExcellent oral and written communication skillsJob Level: ProfessionalAdditional InformationThe base compensation range for this role is: $33.17-$43.27Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.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.BenefitsIn addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participationWhy Biogen?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.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. Read on to learn more about our DE&I efforts.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.