Process Controls and Validation Engineer

Regulatory Jobs; City of Rensselaer (NY); Vor Ort; USD 62.000 - 92.000; Vollzeit

Benefits dieser Stelle

Annual bonus eligibility

Equity awards

401(k) match

Health benefits

Paid time off

Zusammenfassung

Regeneron is seeking a Process Controls and Validation Engineer to provide technical support for manufacturing processes from technology transfer through post-commercial lifecycle management. The role interfaces with Manufacturing, Quality Control and CMC regulatory to ensure robust process control strategies and compliant validation plans.

The ideal candidate will have a background in engineering with increasing levels of responsibility, experience in aseptic processing or biopharmaceutical

Qualifikationen

• Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience.
• Engineer: BS/BA in Engineering with 2+ years industry experience.
• Sr Engineer: BS/BA in Engineering with 5+ years industry experience.

Aufgaben

• Provides technical support to technology transfer, design transfer, process control strategy development, and validation lifecycle.
• Evaluates product and process risks during transfer and development activities.
• Analyzes data from development through late-stage characterization and scale-up history.
• Liaises with Manufacturing, Quality Control, QA and CMC regulatory to manage process lifecycle.

Kenntnisse

Process controls

Validation

Regulatory liaison

Data analysis

Team collaboration

Ausbildung

Assoc Engineer

Engineer

Sr Engineer

Jobbeschreibung

Summary: 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. 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.

Essential Duties and Responsibilities include, but are not limited to, the following:

• 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.
• Authors 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.

Education and Experience:

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

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00