Rensselaer, Indiana, United States · On-site
$62k–$129k/yr
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 posit…
Skills: Change Control, CAPA, cGMP Standards, Risk Assessment, Regulatory Impact Analysis
Nash, Indiana, United States · On-site
Responsibilities & Key Deliverables Ensure PTCED output and its production related activities Control CED/Paint defects due to Process Perform the various lab testing required for PTCED Coordinate and provide supporting …
Skills: PTCED Production, Paint Defect Control, Lab Testing, Kaizen, TPM
New Carlisle, Indiana, United States · On-site
$27/hr–$48/hr
Transform network infrastructure by joining our dynamic team! You'll be at the forefront of developing innovative solutions that drive network stability and scalability, using your technical expertise to create automated…
Skills: Infrastructure Cabling, Network Deployment, Hardware Repair, Fiber Cabling, Copper Cabling
South Bend, Indiana, United States · On-site
Position Overview Our Network Operations Center (NOC) team is the frontline defense against network disruptions, ensuring the stability, security, and performance of our clients’ environments around the clock. Oper…
Skills: Network Troubleshooting, Firewall Management, VPN, DNS Administration, Switching and Routing
Carmel, Indiana, United States · On-site
Radar Engineer Join Aptiv, a global leader in radar technology, revolutionizing the automotive industry with innovative solutions. Our radar development team pioneers cutting-edge advancements that redefine safety and pe…
Skills: Radar System Development, Algorithm Design, Radar Sensor Modeling, Radar Simulation, Anechoic Chamber Testing
Crown Point, Indiana, United States · On-site
$65k–$90k/yr
At Panduit, we don’t just offer a job – we offer a career where your contributions directly impact our customers, the environment and our company’s success. You’ll have the opportunity to grow, innovate, and be a part of…
Skills: Lean Six Sigma, ISO9001 Certification, IATF, Certified Quality Auditor, ASQ Certified Quality Engineer
Pulaski County, Indiana, United States · On-site
Hiab is the pioneer in smart and sustainable on road load handling solutions. We believe in more than just work — we believe in making a difference for our customers to building a better tomorrow. Say Hi! to your next ch…
Skills: MIG Welding, Fabrication, Blueprint Reading, Measurement Tools, Grinding
New Carlisle, Indiana, United States · On-site
$27/hr–$48/hr
Join our dynamic AWS team and become a critical guardian of global cloud infrastructure! You'll play a pivotal role in maintaining the heartbeat of the world's most innovative technology platform, ensuring seamless data …
Skills: Server Hardware Troubleshooting, Network Troubleshooting, Hardware Break-fix, Server Rack Installation, Incident Response
Fort Wayne, Indiana, United States · On-site
$118k–$235k/yr
About Carrier Carrier Global Corporation, global leader in intelligent climate and energy solutions, is committed to creating innovations that bring comfort, safety and sustainability to life. Through cutting-edge advanc…
Skills: Product Management, Product Roadmap, HVAC Controls, Embedded Systems, Stakeholder Management
Crown Point, Indiana, United States · On-site
$65k–$90k/yr
At Panduit, we don’t just offer a job – we offer a career where your contributions directly impact our customers, the environment and our company’s success. You’ll have the opportunity to grow, innovate, and be a part of…
Skills: Lean Six Sigma, ISO9001 Certification, IATF, Certified Quality Auditor, ASQ Certified Quality Engineer
Brazil, Indiana, United States · On-site
Job Description Join our team and leave a legacy that's shaping the future of cryogenic equipment! Technifab and CRYOWorks have merged with CRANE to create CRANE Cryogenics! This collaboration combines advanced technolog…
Skills: Blueprint Reading, Metal Fabrication, Saw Operation, Grinding, Metal Shearing
Indianapolis, Indiana, United States · Hybrid
$114k–$186k/yr
Job Description Job Title: Senior Stress and Lifing Engineer Working Pattern: Full-Time Working location: Indianapolis, IN/Hybrid - 3 Office Days/Week An exciting opportunity has arisen for a Senior Stress and Lifing Eng…
Skills: Finite Element Analysis, Numerical Modeling, Mechanical Integrity Assessment, Stress Analysis, Lifing Assessment
Indianapolis, Indiana, United States · On-site
$90k–$120k/yr
What makes us strong? Our employees in 50 countries worldwide – all working with passion to enable high-tech applications with our strong metals: tungsten and molybdenum. At our Plansee site in Franklin, USA, we speciali…
Skills: Industrial Sales, Marketing Strategy, Commercial Management, CRM, SAP R/3
Indianapolis, Indiana, United States · On-site
$139k–$257k/yr
Band Level 5 Job Description Summary Location: Indianapolis, Indiana Make a meaningful impact at the forefront of advanced cancer care. As Head of QA Operations, you will lead the Quality Assurance Operations organizatio…
Skills: Collaboration, Data Integrity, Decision Making, Leadership, Quality Assurance
East Chicago, Indiana, United States · On-site
$33/hr–$40/hr
Job DetailsLevel: ExperiencedJob Location: East Chicago, IN 46312Position Type: Full TimeSalary Range: $33.00 - $40.00 HourlyJob Category: MarketingReports to: Maintenance Manager FLSA Status: Non- Exempt Position Summar…
Skills: Mechanical Troubleshooting, Electrical Troubleshooting, Pneumatic Systems, Hydraulic Systems, Preventive Maintenance
Indianapolis, Indiana, United States · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, o…
Skills: Assembly, Troubleshooting, Hand Tools, Process Improvement, Oral Communication
Edinburgh, Indiana, United States · On-site
$55k–$65k/yr
Job DetailsLevel: ExperiencedJob Location: GTR Enterprises - Edinburgh, IN 46124Position Type: Full TimeSalary Range: $55,000.00 - $65,000.00 Salary/yearTravel Percentage: Up to 25%Job Shift: DayPOSITION SUMMARY: The Ass…
Skills: Production Scheduling, Team Leadership, Lean Manufacturing, Continuous Improvement, Performance Evaluation
Fort Wayne, Indiana, United States · On-site
$135k–$183k/yr
The Sr. Operations Manager oversees all budgetary, people development, and operational objectives at the site. This role involves managing and leading a team of Operations and Area Managers, coaching and mentoring them t…
Skills: Operational Excellence, People Development, Lean Methodologies, Process Optimization, Performance Management
Indianapolis, Indiana, United States · On-site
$25/hr–$33/hr
Who we are For more than 40 years, Reworld has been a leader in sustainable waste solutions, providing our customers with innovative solutions that help them achieve carbon-negative outcomes. Our Vision Reworld is leadin…
Skills: Industrial Wastewater Treatment, Petroleum Recovery, Waste Stream Sampling, QA/QC Analysis, Bench Testing
Marion, Indiana, United States · On-site
Prysmian is the world leader in solutions for energy and digital connections, developing resilient, high-performing, sustainable, and innovative cable systems for the transmission, power grid, electricity and digital sol…
Skills: Electrical Troubleshooting, PLC Ladder Logic, AC/DC Motors, Motor Control Drives, Industrial Heating Systems
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Develop strategic plans for change control and implement corrective and preventative actions (CAPA) to support manufacturing operations. Coordinate cross-functional teams to assess risk, define scope, and ensure GMP compliance for proposed changes.
Requires a BS/BA in Life Sciences, Engineering, or a related field. Experience requirements vary by level, ranging from 0 to 5+ years of relevant experience.
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 function expertise.
Bulk Drug Substance Manufacturing
Technical Operations
Fill/Finish Manufacturing
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations
Assess sophisticated proposed change controls to evaluate if 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
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.
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 - $128,700.00At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Offices: 777 Old Saw Mill River Road, Tarrytown, New York 10591, US · 81 Columbia Turnpike, Rensselaer, New York 12144, US · 110 Allen Road, Basking Ridge, New Jersey 07920, US · 1 Rockwood Rd, Sleepy Hollow, New York 10591, US · 2425 Matheson Blvd E, Suite 726, Mississauga, Ontario L4W 5K4, CA
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