Associate MSAT Engineer

Regeneron Pharmaceuticals, Inc.; United States; À distance; USD 62 000 - 92 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a skilled professional to support technology transfer activities across internal and external sites. You will help create process descriptions, master plans, and technical reports, while reviewing batch records and automation recipes.

The role uses engineering principles to solve manufacturing problems, analyze data, and drive continuous improvement. On-site collaboration with cross-functional teams is essential to ensure timely, compliant execution.

Qualifications

• Knowledge of biopharmaceutical manufacturing processes and technology transfer principles.
• Ability to apply engineering principles to evaluate process and product behavior and to develop defensible conclusions.
• Familiarity with cGMP requirements, data integrity principles, and regulated documentation practices.

Responsabilités

• Support internal and external technology transfer activities, including facility fit assessments and high-level gap assessments.
• Generate, review, and support documentation associated with technology transfer, including process descriptions, master plans, reports, and technical documents.
• Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing.
• Leverage engineering principles during problem solving and process support.
• Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation.
• Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring.
• Participate in investigations and deviation assessments and support identification of root causes and corrective actions.
• Apply engineering principles to the development and execution of manufacturing support activities.
• Analyze data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing support activities.
• Work effectively in cross-functional teams to support timely execution of SAT deliverables.
• Ensure activities are performed in accordance with cGMP.
• May lead others.
• Perform other duties as assigned.
• Travel to internal manufacturing sites or external partners as required.

Connaissances

Biopharma manufacturing knowledge

Engineering reasoning

cGMP & data integrity

Data analysis & communication

Cross-functional collaboration

Prioritization & time management

Description du poste

Essential Duties and Responsibilities:

• Support internal and external technology transfer activities, including participation in facility fit assessments and high-level gap assessments.
• Generate, review, and support documentation associated with technology transfer, including process descriptions, master plans, reports, and technical documents.
• Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing.
• Leverage engineering principles during problem solving and process support.
• Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation.
• Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring.
• Participate in investigations and deviation assessments and support identification of root causes and corrective actions.
• Apply engineering principles to the development and execution of manufacturing support activities.
• Analyze data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing support activities.
• Work effectively in cross-functional teams to support timely execution oSAT deliverables.
• Ensure activities are performed in accordance with cGMP.
• May lead others.
• Perform other duties as assigned.
• Travel to internal manufacturing sites or external partners as required.

Knowledge, Skills, and Abilities:

• Knowledge of biopharmaceutical manufacturing processes and technology transfer principles.
• Ability to apply engineering principles to evaluate process and product behavior and to develop defensible conclusions.
• Familiarity with cGMP requirements, data integrity principles, and regulated documentation practices.
• Ability to analyze and interpret manufacturing and analytical data; communicate findings clearly in written and verbal formats.
• Strong collaboration skills and ability to work effectively in cross-functional and cross-site environments.
• Ability to manage multiple priorities and deliver high-quality outputs within timelines.

Does this sound like you?

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.

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.

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