Technology Transfer Engineer
Regeneron Pharmaceuticals•Rensselaer, NY
•$62,355 - $110,000•Onsite
About The Position
Regeneron is currently looking for a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. This technical services department handles a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The Process Controls and Validation Engineer provide technical support to manufacturing, quality, chemistry manufacturing compliance regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
Requirements
- BS in bioengineering, chemical engineering, or related engineering field
- Associate Process Controls & Validation Engineer: 0-2 years of experience
- Process Controls & Validation Engineer: 2 + years of experience
- Level will be determined based on experience
Nice To Haves
- A background in aseptic processing, drug substance development, drug product development, combination product development or biopharmaceutical/combination product validation is preferred
Responsibilities
- Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
- Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history
- Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
- Ensures alignment of standard operating procedures, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
- Provides support to audits/inspections and drafting of chemistry manufacturing compliance sections of regulatory submission as needed
- Analyzes data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing process performance and control
- Provides support for laboratory studies and/or at-scale studies performed to support process characterization and validation activities
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
