Manufacturing Engineer III – Solid Dose Manufacturing
Job Location:
Durham County, NC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
About this role
As a Manufacturing Engineer III you will serve as a key technical resource supporting manufacturing equipment within our production areas with a focus on solid dose (OSD/ASO) operations. This role plays a critical part in maintaining reliable manufacturing processes improving equipment performance and driving continuous improvement initiatives. You will partner closely with manufacturing maintenance and cross-functional teams to troubleshoot issues lead equipment-related projects and ensure successful validation and implementation of new or modified systems.
What youll do
- Support manufacturing operations by troubleshooting equipment issues and driving root cause analysis implementing sustainable solutions to improve uptime and reliability
- Serve as the equipment SME for assigned manufacturing systems providing hands-on technical support and guidance
- Lead and support continuous improvement (CI) initiatives to optimize equipment and manufacturing performance
- Design specify and support installation or modification of manufacturing equipment and systems
- Develop execute and support CQV (Commissioning Qualification and Validation) activities including protocol authoring execution and reporting
- Partner with process and maintenance teams to resolve equipment issues and enhance overall manufacturing capability
- Lead or contribute to equipment-related projects including capital projects tech transfers and system upgrades
- Support onboarding training and drawing/documentation management for equipment and systems
- Participate in investigations (deviations CAPAs) and change controls related to equipment and process improvements
- Provide on-call support as needed with a focus on parenteral fill (PF) or manufacturing support areas
Who you are
Youre a hands-on self-motivated engineer who takes initiative and enjoys working directly with equipment and manufacturing teams. You thrive in a fast-paced environment proactively identifying opportunities for improvement and driving solutions from concept through implementation.
Youre also flexible and dependable willing to support extended hours during critical project timelines and participate in an on-call rotation to ensure consistent manufacturing support.
Required skills
- Bachelors and/or masters degree in engineering from an accredited college or university
- 2 years of experience supporting manufacturing equipment
- Experience with some or all the below in a cGMP environment:
- Troubleshooting and root cause analysis
- Continuous improvement methodologies and equipment optimization
- Hands-on mechanical aptitude with manufacturing equipment
- Experience supporting CQV activities including protocol development and execution
- Strong ownership mindset with demonstrated initiative and accountability
Preferred skills
- Experience with some or all the manufacturing equipment below:
- Solid dose manufacturing (OSD OSM or ASOS)
- Parenteral fill (PF) operations
- Hands-on experience with equipment such as:
- Chromatography skids or columns
- Tablet presses
- Encapsulation machines
- Isolators
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 $10000 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 onto 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.
Required Experience:
IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
