Process Controls and Validation Engineer

About the role

Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The Process Controls and Validation Engineer provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

Responsibilities

• Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
• 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.
• Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
• Authoring protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
• Applies engineering principles to the development and execution of process controls and validation strategies.
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
• Works effectively and efficiently in a team-oriented environment.
• Provides support for laboratory studies and/or studies performed at manufacturing scale.

Requirements

• Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience, or equivalent combination of education and experience.
• Engineer: BS/BA in Engineering with 2+ years industry experience; or equivalent combination of education and experience.
• Sr Engineer: BS/BA in Engineering with 5+ years industry experience; or equivalent combination of education and experience.

Qualifications

A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation is preferred, but not required.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.

Pay

Salary Range (annually) $62,355.00 - $92,400.00