BioSpace
Principal Process Controls & Validation Engineer
BioSpace, East Greenbush, New York, United States
Principal Process Controls & Validation Engineer
Regeneron is currently looking for a Principal/Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. 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. This role 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
Provide 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.
Evaluate product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
Analyze information and data from development through late stage-characterization as well as at-scale manufacturing history.
Liaise with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
Author protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
Ensure alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
Provide support to audits/inspections and draft CMC sections of regulatory submission as needed.
Apply engineering principles to the development and execution of process controls and validation strategies.
Analyze data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
Develop and monitor health of the business using key performance indicators.
Develop and improve cross‑functional business and manufacturing processes.
Work effectively and efficiently in a team‑oriented environment.
Provide support to laboratory studies and/or studies performed at manufacturing scale.
This Role Might Be For You If You
Can perform advanced problem solving, including addressing ambiguous issues and situations.
Can accurately scope projects – break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk.
Can deal with changing priorities and adapt to change.
Can use technical expertise to influence a non‑technical audience on a path forward.
Qualifications
BS/BA in Engineering; Biomedical engineering or Chemical Engineering preferred.
Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product.
Staff Process Controls & Validation Engineer: 10+ years in Drug Product/Labeled Drug Product.
Or equivalent combination of education and experience in Drug Product/Labeled Drug Product.
Experience in aseptic processing, drug product development, labeled drug product processing, or biopharmaceutical/combination product validation is required.
Salary Range (annually) $90,800.00 - $173,400.00
Equal Opportunity Employer Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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Responsibilities
Provide 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.
Evaluate product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
Analyze information and data from development through late stage-characterization as well as at-scale manufacturing history.
Liaise with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
Author protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
Ensure alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
Provide support to audits/inspections and draft CMC sections of regulatory submission as needed.
Apply engineering principles to the development and execution of process controls and validation strategies.
Analyze data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
Develop and monitor health of the business using key performance indicators.
Develop and improve cross‑functional business and manufacturing processes.
Work effectively and efficiently in a team‑oriented environment.
Provide support to laboratory studies and/or studies performed at manufacturing scale.
This Role Might Be For You If You
Can perform advanced problem solving, including addressing ambiguous issues and situations.
Can accurately scope projects – break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk.
Can deal with changing priorities and adapt to change.
Can use technical expertise to influence a non‑technical audience on a path forward.
Qualifications
BS/BA in Engineering; Biomedical engineering or Chemical Engineering preferred.
Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product.
Staff Process Controls & Validation Engineer: 10+ years in Drug Product/Labeled Drug Product.
Or equivalent combination of education and experience in Drug Product/Labeled Drug Product.
Experience in aseptic processing, drug product development, labeled drug product processing, or biopharmaceutical/combination product validation is required.
Salary Range (annually) $90,800.00 - $173,400.00
Equal Opportunity Employer Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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