Change Control Specialist

Regeneron; City of Rensselaer (NY); Vor Ort; USD 62.355 - 128.700; Vollzeit

Zusammenfassung

Regeneron in Rensselaer, NY is seeking Change Control Specialists to develop plans for CAPAs and process improvements supporting manufacturing operations. You will assess proposed changes, determine regulatory impact, and coordinate comprehensive change controls documentation.

You will lead cross‑functional meetings, mentor teams for GMP‑compliant controls, and manage multiple projects while presenting to senior leadership. On‑site work model with competitive rewards.

Qualifikationen

• BS/BA in Life Sciences, Engineering, or related field, or equivalent experience.
• Experience in change control processes and CAPA in manufacturing environments.
• Ability to coordinate cross-functional teams and prepare technical documentation.
• Familiarity with cGMP standards and regulatory impact assessment.

Aufgaben

• Develop plans to advance change control initiatives and CAPAs.
• Assess proposed change controls against company standards.
• Coordinate documentation covering scope, risk, and regulatory impact.
• Lead cross-functional meetings to drive change implementation.
• Mentor teams for GMP-compliant change controls.
• Monitor multiple projects concurrently and address obstacles.
• Present critical change controls to senior leadership.
• Document training and assist with onboarding new employees.

Kenntnisse

Change control

CAPA implementation

Cross-functional coordination

Regulatory compliance

Ausbildung

BS/BA in Life Sciences, Engineering, or related field

Equivalent combination of education and experience

Jobbeschreibung

Build Our Future Together

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying functional expertise.

Current Departments With Openings

• Bulk Drug Substance Manufacturing
• Technical Operations
• Fill/Finish Manufacturing

When & Where

• Location: Rensselaer, New York, United States
• Work model: Monday‑Friday, 8am-4:30pm

Discover Your Role

• Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) and process improvements in support of manufacturing operations
• Assess sophisticated proposed change controls to evaluate if the proposal satisfies company standards
• Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
• Review, edit, and revise controlled documentation in accordance with cGMP standards
• Coordinate and/or lead cross‑functional meetings with multiple departments to drive change control implementation
• Provide advice and mentorship to cross‑functional teams to enable successful and GMP compliant change controls
• Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner
• Present business critical and regulatory impactful change controls to senior leadership
• Document all training
• Assist with the training of new employees

This Role Requires

• BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience, and the following amount of experience for each level:
  • Associate Change Control Specialist: 0–2+ years of relevant experience
  • Change Control Specialist: 2+ years of relevant experience
  • Senior Change Control Specialist: 5+ years of relevant experience
  • Level will be determined based on experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.

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. 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., 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 - $128,700.00