Sr. Engineer, MS&T – Aseptic Drug Product
About The Position
Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will play a critical role in advancing aseptic manufacturing operations by providing technical leadership, driving process performance, and supporting the successful introduction of new products and technologies. Working closely with Manufacturing, Quality, Engineering, and global partners, you will help solve complex challenges, lead continuous improvement initiatives, and ensure a reliable supply of high-quality products for patients. This is an exciting opportunity to make a meaningful impact in a collaborative environment that values innovation, scientific excellence, and operational excellence.
Requirements
- Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; Master's degree with 4+ years of experience; or Doctorate degree with 2+ years of experience.
- Proven experience supporting GMP biopharmaceutical manufacturing operations within a regulated environment.
- Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
- Experience supporting Tech Transfer, process validation, lifecycle management, or manufacturing process improvements.
- Working knowledge of global GMP regulations, validation requirements, and quality compliance expectations.
- Strong analytical skills with the ability to interpret process data, identify trends, and drive data-based decisions.
- Excellent technical writing, communication, and cross-functional collaboration skills.
- Demonstrated ability to lead technical initiatives and contribute effectively within cross-functional teams.
Nice To Haves
- Applied Statistics
- Manufacturing Production
- Manufacturing Technologies
- Operational Excellence
- Process Control
- Quality Compliance
- Regulatory Compliance
- Technical Leadership
- Technology Transfer
Responsibilities
- Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
- Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
- Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
- Monitor and trend CQAs and CPPs to ensure consistent product quality and process control.
- Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
- Support the introduction of new equipment, systems, and manufacturing processes through startup and implementation activities.
- Author and support process change documentation while collaborating with Engineering, Manufacturing, and Validation teams.
- Provide technical expertise for remediation efforts, project deliverables, technical assessments, and process reports.
- Collaborate with Development and site partners to execute Tech Transfer activities and ensure successful product commercialization.
- Drive OPEX initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- vacation, personal days, holidays and other leaves
- performance-based cash incentive
- eligibility to be considered for annual equity awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
