32 engineering jobs found in Rensselaer, NY

We are currently looking to add a Cleanroom & HEPA Certification Specialist to our growing team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Cleanroom & HEPA Certification Specialist will support our manufacturing by coordinating the performance of preventive maintenance and on-demand work of certification activities. As a Cleanroom & HEPA Certification Specialist, a typical day might include the following: Planning and scheduling outside contractors/vendors to perform scheduled and/or non-scheduled PM or general work Working with Certification Vendor(s) and Regeneron Facilities, Manufacturing and Lab Management Scheduling Groups to ensure timely certifications of HEPA filtered areas and equipment Recording certification activities in electronic records Ensuring safe and efficient maintenance of all Cleanroom and HEPA supplied...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Biotech Production Specialists are on the front line, producing our life changing products and have a passion for assisting those in need by using biotechnology. They perform all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs. What to look forward to: Competitive Compensation- Regeneron offers highly competitive base pay and employees working premium shifts receive incentive pay, such as shift differential and/or weekend pay. All employees receive equity awards and are eligible for annual performance bonuses. We offer comprehensive health coverage, tuition reimbursement, and qualified employees may receive assistance paying down student loans. Relocation assistance is also available for eligible new hires. Work Life...

We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team.   This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include the following: • Acting as Regeneron’s representative in meetings with external Partners to discuss changes for applicable products • Participating in internal cross functional teams on global change management of partnered products • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures • Developing relationships with end users and providing advice on best...

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

We are currently looking to fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ensures adherence to cGMPs , internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process improvements, ensuring robust training for system end users, and supporting the Quality Management System.     As a Principal Quality Compliance Specialist, a typical day might include the following:   Developing and executing a comprehensive training strategy for the change control quality system.   Leading training for end users of the Change Control System.   Partnering with counterparts to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process and associated procedures.   Sponsoring and advocating for...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron’s sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, and maintaining Regeneron’s sophisticated biopharmaceutical manufacturing processes at our Industrial Operation and Product Supply site and at IOPS contract manufacturing partner sites. As a Senior Automation Engineer (CMO Support), a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering...

We are currently looking 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. Current Department with Openings: Manufacturing In this role, a typical day might include the following: Craft business plans to independently advances 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...

We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. In this role, a typical day might include the following: Compliance Apply strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to sophisticated problems. Lead proactive evaluation and education of site GMP compliance against current...

We are currently looking to fill an Associate Director/Director Investigations (Quality Control) position. This position is responsible for providing direction and oversight to the review, approval and management of investigations and corrective and preventive actions. In this role, a typical day might include the following: Leads a team with direct oversight of review and approval for GMP Documents May review, verify and approve system records Collaborates cross functionally to provide succinct support to teams to strive to quality outcomes May approve and review Policy/SOP revisions Provides direction for cross-functional teams. Serves as an escalation point as well as determination when additional escalation is required Identify leading practices and recommend improvements to continuously improve compliance profile Serves as a subject matter authority (SME) to present topics to management and during inspections Supervises relevant quality system...

We are currently looking to fill a Process Technician position with a Wednesday-Saturday 6:00 a.m.-4:30 p.m. schedule. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 6:00am-2:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30m As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment Identifying any off-nominal conditions with mechanical equipment and mechanical troubleshooting of...

We are currently looking to fill an Associate Biotech Production Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Biotech Production Specialists are on the front line, producing our life changing products and have a passion for assisting those in need by using biotechnology. They perform all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs. What to look forward to: Competitive Compensation- Regeneron offers highly competitive base pay and employees working premium shifts receive incentive pay, such as shift differential and/or weekend pay. All employees receive equity awards and are eligible for annual performance bonuses. We offer comprehensive health coverage, tuition reimbursement, and qualified employees may receive assistance paying down student loans....

We are currently looking to fill a Plant Utilities Technician position with a Wednesday-Saturday 6:00am-4:30pm schedule. Our Plant Utilities Technicians are responsible for start-up, normal operation, monitoring, maintaining and shutdown of Plant Utility systems and equipment within Plant Utility mechanical rooms that support overall facility buildings. Please note training will be Monday-Friday 7:00am-3:30pm for the first few weeks. Working hours thereafter will be Wednesday-Saturday 6:00am-4:30pm. As a Plant Utilities Technician, a typical day might include the following: Maintaining high pressure steam and hot water boilers, controls and associated equipment Maintaining boiler and cooling tower chemical treatment program Maintaining all other Plant Utility equipment such as boiler pretreatment water, condensate return, natural gas, domestic potable water, tepid water, wastewater Monitoring controls of plant systems using Building Automation System (BAS) or...

We are currently looking to fill a Process Technician position with a Saturday-Wednesday 10:00pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 7:00 a.m. - 3:30 p.m. for up to six months. As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment...

We are currently looking to fill a Process Technician position with a 6:00am-4:30pm Sunday-Wednesday schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Process Technicians play a vital role in supporting our manufacturing operations. They provide operational, maintenance, and troubleshooting support for manufacturing process area maintenance through strict compliance with Standard Operating Procedures (SOPs) and cGMPs. Please note training will be Monday-Friday 6:00am-2:30pm for up to six months. As a Process Technician, a typical day might include the following: Performing daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment Ensuring safe and efficient hands-on maintenance of all plant manufacturing equipment and related support equipment Identifying any...

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron’s sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5...

We are currently looking to fill multiple Investigation Specialist positions. These positions perform all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations. Current Department with Openings: Fill Finish Manufacturing Global Manufacturing Quality Assurance Quality Control Systems Technical Operations In this role, a typical day might include the following: Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports Communicating findings and recommendations at group meetings Reviewing completed batch records and logbooks in accordance with...

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!   Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.   Why you’ll love working at Axogen:  Friendly, open, and fun team culture that values unique perspectives  Company-wide dedication to profoundly impacting patients’ lives  Comprehensive, high-quality benefits package effective on date of hire  Educational assistance available for all employees  Matching 401(k) retirement plan  Paid holidays, including floating holidays, to be used at your discretion  Employee Stock Purchase Plan  Referral incentive program  Axogen Mission and...

Job Description Summary Job Description We are the makers of possible    BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.   Davol Inc./C.R. Bard has joined BD. BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years,...