Engineer II, Manufacturing
About This Role
In the position of Engineer II, Manufacturing, you will play a pivotal role within our dynamic manufacturing team, providing critical equipment support and engineering technical troubleshooting for drug substance manufacturing equipment. You will be an integral part of the team, managing small engineering projects with guidance, and participating in cross-functional teams to implement change and enhance existing processes. Your work will significantly contribute to new product Tech Transfer activities and investigations, ensuring our manufacturing processes are efficient and compliant. By supporting the design, specification, and installation of new equipment and modifications to existing systems, you will directly impact the quality and reliability of our manufacturing operations. Your contributions will be vital to maintaining our high standards and driving forward our innovation in drug manufacturing.
What You’ll Do
Troubleshoot and identify equipment system improvements to support manufacturing operations.
Design and develop validation protocols and provide expertise for equipment and automation modifications.
Coordinate equipment-related projects, including technology transfers and continuous improvement initiatives.
Develop and manage Equipment & Cleaning Validation Protocols, offering technical training and on-floor guidance.
Lead equipment commissioning and qualification activities, ensuring project deliverables are tracked and reported.
Attend Factory Acceptance Testing (FAT) as a validation subject matter expert and support equipment startup.
Maintain personal training records, goal development, compliance workflow, and progress tracking.
Support the implementation of new manufacturing processes and technology transfers.
Investigate process or equipment failures and implement corrective changes.
Manage and track completion timelines for compliance tasks such as change controls and deviation investigations.
Provide validation-related support for projects and continuous improvement initiatives.
Who You Are
You are a detail-oriented and proactive individual who thrives in a collaborative and fast-paced environment. Your strong communication skills enable you to work effectively across teams and present your findings confidently. You possess a keen analytical mindset, allowing you to troubleshoot complex issues and develop innovative solutions. Your dedication to continuous improvement drives you to identify and implement best practices, enhancing our manufacturing processes. You are adaptable and ready to take on challenges that contribute to the success of our projects and overall business goals.
Required Skills
BS in Engineering.
0-2 years of experience in GMP validation, manufacturing, engineering, or facilities in a pharmaceutical environment.
Knowledge of GMPs and EMEA regulations.
Experience in Cleaning and Equipment Validation Philosophy.
Experience in a pharmaceutical or biotech manufacturing environment.
Excellent oral and written communication skills.
Ability to work on-site.
Ability to work rotating shifts/on-call, extended coverage support and weekends as needed.
Preferred Skills
Demonstrated ability to identify efficiency gaps and implement best practices.
Experience in supporting technology transfer and continuous improvement projects.
Additional Information
Base 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.
In 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 insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A 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 year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why 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.
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