Sr. Engineer II, Mfg Sciences (Parenteral Filling) jobs in United States
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Biogen · 4 days ago

Sr. Engineer II, Mfg Sciences (Parenteral Filling)

positionTriangle, NC
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$109K/yr - $146K/yr
date4+ years exp

Biogen is a mid-sized biotechnology company committed to excellence and innovation. The Sr. Engineer II will provide technical expertise to manufacturing campaigns, lead investigations and project implementation, and ensure compliance with industry standards.

BiotechnologyHealth CareNeuroscienceTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site
Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed
Provide technical and operational guidance to Manufacturing during GMP campaigns
Lead technical investigations towards process impact assessments and ensure timely completion and communication
Author Manufacturing and Process Performance Qualification validation protocols and technical reports
Lead small teams on technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate
Be the Subject Matter Expert to support inspections and audits
Lead process investigations while servicing as the point of contact to broader organization
Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site
Facilitate meetings with various stakeholders and communicate to management on the status of programs

Qualification

Parenteral Filling OperationsProcess Performance QualificationCGMP regulationsData analysisProject managementAnalytical skillsCommunication skillsTeam collaboration

Required

Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 6 years of relevant experience is required OR
Masters degree in Engineering or relevant scientific/technical discipline with at minimum 4 years of direct experience OR
Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 2 years of direct experience
Good communication and project management skills appropriate for leadership of tech transfer projects
In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities
Excel at working in a team environment
Comfortable analyzing scientific datasets/analytical skills with excellent written skills
Ability to work independently and support a large cross-functional group
Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
Ability to work weekends and be on call

Benefits

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

Company

Biogen

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Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
dateFounded in 1978
location
Cambridge, Massachusetts, USA
people-size5001-10000 employees
web-link
https://www.biogen.com/en_us/home.html

H1B Sponsorship

Biogen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)

Funding

Current Stage
Public Company
Total Funding
$1.5B
Key Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO

Leadership Team

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Robin C. Kramer
Executive Vice President, Chief Financial Officer
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Priya Singhal
Executive Vice President, Head of Development
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Recent News

Investing.com
Stoke Therapeutics stock falls after delayed Phase 3 readout timeline
2026-01-13
Business Wire
Ionis well-positioned for continued momentum and substantial value creation in 2026 with two new independent launches and several pivotal data readouts
2026-01-12
PR Newswire
Proximity Health Solutions and Biogen Named Finalists for the SCOPE '26 Participant Engagement Award
2026-01-09
Company data provided by crunchbase