Manufacturing Engineer jobs at Quest Global

The Role The Manufacturing Engineer is responsible for developing automated solutions, implementing new processes, optimizing existing processes, automated data collection, and executing the industrial control and programming strategy for GTI's production facilities. This position will work closely with the multiple teams to ensure flawless and quick speed to market. Success is gauged on the ability to deliver quality, detailed, and efficient solutions at scale. The Manufacturing Engineer will play a pivotal strategic role in priority projects from a feasibility standpoint through a full IQ, OQ, PQ validation and hand-off with a technical transfer to the site production team. They work collaboratively with multiple teams to deliver productivity improvements and Continuous Improvement. Responsibilities 50% travel required Coordinate the efforts of Engineering and technical resources based on Senior Leadership Priorities and Site 90-day plan priorities. Work with other departments (i.e. Prod Development, Project Management, Quality, Compliance, Operations, etc.) to integrate new systems. Dedicate start-up management support for selected complex project integrations. Ensures constant updates are provided to the VP of Manufacturing on the status of projects and improvement efforts in the facilities. SME for automated packaging equipment, flow wrappers, beverage line, multi-combi scales, bag filling equipment, integrations, and automation. Conduct studies, identify problems, recommend alternatives, and implement solutions in coordination with other teams. Develop and deploy automated solutions for numerous processes to gain efficiency and streamline workflows. Provide support to Start-up facilities via technical transfer: Staffing Equipment layout and requirements Construction hand off Regulatory engagement Best-practice processes Technical transfer related to equipment Work with integrators, contractors, and site personnel to bring new functionality online and to troubleshoot issues as they arise. Work with site maintenance and facilities personnel to develop and execute preventative maintenance plans. Maintain up to date as-built records and drawings for existing and new deployments. Integrate existing equipment with live data stream to dashboard with historian, report generation, alarms, notifications, and live visuals for site teams to track daily production. Other duties as assigned Qualifications Bachelor's degree in engineering and 5+ years Operations and Engineering experience in a manufacturing environment. Proven strategic experience in overseeing all aspects of large-scale manufacturing projects Knowledgeable of TPM-based continuous improvement methodology Knowledgeable of Engineering problem solving Able to diagnose complex technical systems and develop simple human-machine interface and training solutions for optimal operations. Experience in industrial networking/automation (SCADA-Ignition, ITOT, cyber security), controls experience (PLC - AB, Omron, Schneider, ladder logic \ STX), business and data analytics for manufacturing operations (Power Bi, Tableau,) vision systems, and robotics. Highly motivated, self-directed, innovative and able to work independently or among teams with keen judgement, common sense and resourcefulness Adapts and thrives in a demanding, start-up, fast-paced environment Possesses a high level of critical thinking Effective time-management skills and ability to multi-task Ability to work well with others while also completing individually assigned tasks. Operates with a high level of professionalism and integrity, including dealing with confidential information Must understand and comply with the rules, regulations, policies, and procedures of GTI Must have a solid understanding of the Medical Marijuana laws, rules and regulations set forth by the state; a pursuit to further their understanding and knowledge of the industry and the laws. Safety and Compliance Be aware of hazards in the workspace. Retain and understand department specific training. Report safety incidents/ concerns and comply with follow-up actions. Be compliant with area safety requirements, state regulations and PPE requirements. Follow GMP, biosecurity, sanitation or other quality and compliance requirements. Perform record keeping accurately and completely as directed by a lead or supervisor. Maintain and calibrate tools, equipment and machinery as directed by a lead or supervisor. Report and escalate safety & quality concerns. Working Conditions While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions. Must be able to sit and/or stand for extended periods of time while maintaining focus. Must be able to lift, carry, and balance up to 50 pounds (and up to 100 pounds with assistance) AND must be able to do so with extreme care and caution when working with product. Ability to work in a fast-paced, changing, and challenging environment Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil). Additional Requirements Must pass any and all required background checks Must be and remain compliant with all legal or company regulations for working in the industry Must possess valid driver's license Must be a minimum of 21 years of age Must be approved by state badging agency to work in cannabis industry The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance. Green Thumb Pay Range$90,000-$110,000 USD

Newark, DE, United States **Why join Hologic:** You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. **What to expect:** Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies, and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing cost determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. **What we expect:** + Performs complex experiments that may require support and coordination of other engineers or technicians. + Active participant in R&D projects, providing design input and ensuring projects can be translated into cost-effective production. Supports R&D in marking cost estimated for equipment, tools, and components. + Responsible for the manufacture and performance of assigned product line (s). + Responsible for setting up fabrication and assembly procedures to manufacture products. Establishes methods and tooling needed for new and existing processes. Assists in the design of tooling and fixtures. + Initiates and/or approves necessary changes in design, drafting, tooling, methods, processes, and documentation that affects the manufacturing process. + Oversee the creation and revision of standard operation procedures, organizational standards, directives pertaining to scheduling, cost control and production performance evaluation. Develop, verifies and validate processes for manufacturing. + Responsible for the maintenance of production equipment and works with Facilities on the implementation of predictive maintenance of manufacturing equipment. + Responsible for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in standard manufacturing. Works in conjunction with other departments where appropriate. + Evaluate and develop process control data for trending analysis. Analyzes defects, provides feedback, and implements process improvements. + Participates in design reviews, working with R&D and manufacturing to resolve all issues, particularly those arising from the violation of design standards or changes from existing manufacturing procedures. + Actively supports and adheres to the Quality Policy and Quality System procedures. + Identify and lead complex projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs. + Establish collaborative relationships with all stakeholders within the site and create links with experts within the Hologic network. + Maintains professional and technical knowledge by attending educational workshops. + Manage one project without supervision. + Train and mentor Manufacturing Engineer 1 + Be a change agent driving improvement on a daily basis. **Education & Experience:** + Preferred Minimum Non-Technical Degree: College Degree + Preferred Minimum Technical/Advanced Degree: Technical Bachelor's Degree + Preferred Minimum Non-Technical Degree: 5-8 Years + Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor's Degree, 1-3 Years with Master's Degree, 0-1 Years with PhD + Automation experience, such as implementation of an automated cell/line is beneficial. + Experience in rapid scale up of new products or operations is beneficial. The annualized base salary range for this role is $97,500 to $152,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. **Agency and Third Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** **_\#LI-PR1_** **_Must follow all applicable FDA regulations and ISO requirements._** **_Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)_**

Why join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. What to expect: Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies, and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing cost determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. What we expect: Performs complex experiments that may require support and coordination of other engineers or technicians. Active participant in R&D projects, providing design input and ensuring projects can be translated into cost-effective production. Supports R&D in marking cost estimated for equipment, tools, and components. Responsible for the manufacture and performance of assigned product line (s). Responsible for setting up fabrication and assembly procedures to manufacture products. Establishes methods and tooling needed for new and existing processes. Assists in the design of tooling and fixtures. Initiates and/or approves necessary changes in design, drafting, tooling, methods, processes, and documentation that affects the manufacturing process. Oversee the creation and revision of standard operation procedures, organizational standards, directives pertaining to scheduling, cost control and production performance evaluation. Develop, verifies and validate processes for manufacturing. Responsible for the maintenance of production equipment and works with Facilities on the implementation of predictive maintenance of manufacturing equipment. Responsible for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in standard manufacturing. Works in conjunction with other departments where appropriate. Evaluate and develop process control data for trending analysis. Analyzes defects, provides feedback, and implements process improvements. Participates in design reviews, working with R&D and manufacturing to resolve all issues, particularly those arising from the violation of design standards or changes from existing manufacturing procedures. Actively supports and adheres to the Quality Policy and Quality System procedures. Identify and lead complex projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs. Establish collaborative relationships with all stakeholders within the site and create links with experts within the Hologic network. Maintains professional and technical knowledge by attending educational workshops. Manage one project without supervision. Train and mentor Manufacturing Engineer 1 Be a change agent driving improvement on a daily basis. Education & Experience: Preferred Minimum Non-Technical Degree: College Degree Preferred Minimum Technical/Advanced Degree: Technical Bachelor's Degree Preferred Minimum Non-Technical Degree: 5-8 Years Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor's Degree, 1-3 Years with Master's Degree, 0-1 Years with PhD Automation experience, such as implementation of an automated cell/line is beneficial. Experience in rapid scale up of new products or operations is beneficial. The annualized base salary range for this role is $97,500 to $152,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-PR1 Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)

Newark, DE, United States **Why join Hologic:** You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. **What to expect:** Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies, and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing costs, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Normally receives detailed instructions on all work. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally. **What we expect:** + Perform experiments of limited scope and collect data. + Participate in the transfer of design changes from design engineering to manufacturing. + Define and develop assembly and test methods for assigned product line. + Specify and provide all necessary tools, equipment, fixtures, and facilities required for assigned product line. + Assure that work instructions and drawings are created and updated when necessary. + Assists in maintaining existing mechanical and electrical test fixtures. + Assist in developing, verifying, and validating processes for manufacturing. + Monitor quality reports and field performance of assigned product line, identify trends, investigate problems, perform root cause analysis, and recommend and implement corrective actions. + Actively supports and adheres to the Quality Policy and Quality System procedures. + Support projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs + Establish collaborative relationships with all stakeholders within the site. + Maintains professional and technical knowledge by attending educational workshops. + Manage one project at a time under a more senior Engineer supervision. **Education & Experience:** + Preferred Minimum Non-Technical Degree: College Degree + Preferred Minimum Technical/Advanced Degree: Technical Bachelor's Degree + Preferred Minimum Non-Technical Degree: 0-2 Years + Preferred Minimum Technical/Advanced Degree: 0-1 Years **Skills:** + Proficient in MS Office + Detail oriented + Ability to work well within a team environment + Ability to read and interpret mechanical drawings + Ability to understand, troubleshoot and resolve issues with equipment & processes + Strong written, verbal, and interpersonal communication skills + Strong organizational and time management skills + Ability to work independently + Takes initiative + Training or certification in Six Sigma, SPC and/or other statistical process control methods is beneficial + SolidWorks and AutoCAD is beneficial + Understanding of Lean Manufacturing principles is beneficial + Understanding of Root Cause and Root Cause Failure Analysis Methodologies is beneficial The annualized base salary range for this role is $65,000 to $102,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. **Agency and Third Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** **_\#LI-PR1_** **_Must follow all applicable FDA regulations and ISO requirements._** **_Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)_**

Why join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career. What to expect: Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies, and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing costs, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations. Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Normally receives detailed instructions on all work. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally. What we expect: Perform experiments of limited scope and collect data. Participate in the transfer of design changes from design engineering to manufacturing. Define and develop assembly and test methods for assigned product line. Specify and provide all necessary tools, equipment, fixtures, and facilities required for assigned product line. Assure that work instructions and drawings are created and updated when necessary. Assists in maintaining existing mechanical and electrical test fixtures. Assist in developing, verifying, and validating processes for manufacturing. Monitor quality reports and field performance of assigned product line, identify trends, investigate problems, perform root cause analysis, and recommend and implement corrective actions. Actively supports and adheres to the Quality Policy and Quality System procedures. Support projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs Establish collaborative relationships with all stakeholders within the site. Maintains professional and technical knowledge by attending educational workshops. Manage one project at a time under a more senior Engineer supervision. Education & Experience: Preferred Minimum Non-Technical Degree: College Degree Preferred Minimum Technical/Advanced Degree: Technical Bachelor's Degree Preferred Minimum Non-Technical Degree: 0-2 Years Preferred Minimum Technical/Advanced Degree: 0-1 Years Skills: Proficient in MS Office Detail oriented Ability to work well within a team environment Ability to read and interpret mechanical drawings Ability to understand, troubleshoot and resolve issues with equipment & processes Strong written, verbal, and interpersonal communication skills Strong organizational and time management skills Ability to work independently Takes initiative Training or certification in Six Sigma, SPC and/or other statistical process control methods is beneficial SolidWorks and AutoCAD is beneficial Understanding of Lean Manufacturing principles is beneficial Understanding of Root Cause and Root Cause Failure Analysis Methodologies is beneficial The annualized base salary range for this role is $65,000 to $102,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-PR1 Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)

CEL Critical Power - Powering the AI Revolution: CEL has an opportunity for you to join our rapidly growing US business, where you will have an opportunity to make a significant impact on our immediate and long-term success of our Supply Chain function. CEL is an Irish based 40-year manufacturer, distributor and exporter of electrical switchgear and controls, and related products and services, now focused on the supplying the global Data Centre industry. Operating from our newly acquired 400,000ft2 facility in Williamsburg, Virginia, we aim to double in size each year for the next three years. CEL is led by a hard-working team who follow traditional working practices, value collaboration, continuous improvement, excellence in quality and commercial curiosity; this is your chance to develop your career as part of a dynamic US SMT who will shape the future of our business. About The Role: Reporting to the Continuous Improvement Manager, the Manufacturing Engineer is responsible for designing, optimizing and supporting manufacturing processes to ensure efficient, cost-effective and high-quality production of our low voltage switchgear products. This role involves continuous improvement, technical problem-solving, and collaboration across production, quality, and design teams. The successful candidate will be passionate about what they do and thrive in a fast-paced environment. What You'll Be Doing: Process Design & Optimization: Develop and improve manufacturing processes for assembly of low voltage switchgear. Implement lean manufacturing principles to reduce waste and improve throughput. Create and maintain process documentation, work instructions, and SOPs. Production Support: Provide technical support to resolve process and equipment issues on the shop floor. Ensure smooth transition from design to production, including process validation. Monitor and improve cycle times and overall equipment effectiveness (OEE). Equipment & Tooling Management: Specify, procure, and maintain production equipment and tooling. Optimize machine setups and ensure preventive maintenance schedules are followed. Introduce automation and ergonomic solutions where feasible. Quality Assurance: Collaborate with Quality team to ensure compliance with electrical standards and specifications. Conduct root cause analysis for defects and implement corrective actions. Support initiatives to improve First Pass Yield and reduce scrap. New Product Introduction: Work with design engineering to industrialize new products for manufacturability. Develop process flows, work instructions, and training for new product launches. Ensure scalability of processes for medium-volume production. Data Analysis & Reporting: Monitor key metrics such as cycle time, scrap rate, and OEE. Use data-driven approaches to identify bottlenecks and implement improvements. Prepare reports for management on process performance and improvement projects. Safety & Compliance: Ensure all processes comply with health, safety, and environmental regulations. Conduct risk assessments for new equipment and processes. Promote a culture of safety on the shop floor. Continuous Improvement: Lead Kaizen events and Six Sigma projects to enhance productivity. Drive cost reduction initiatives without compromising quality. Stay updated on new manufacturing technologies and best practices. Requirements What You'll Need: Degree in Manufacturing Engineering, Mechanical/Electrical Engineering, or related discipline. +5 years' experience in a manufacturing engineering role, preferably in electrical or mechanical assembly. Strong knowledge of lean manufacturing and continuous improvement tools. Proficiency in MS Office, CAD software and ERP systems. Excellent problem-solving, analytical, decision-making skills. Strong communication and negotiation skills. Capable of managing short-term project teams and fostering collaboration across departments. We strongly believe that seeking out and hiring the most diverse talent and creating an inclusive workplace is the way to create an exceptional and innovative workplace for our employees which will deliver excellence in service to our customers. We encourage applications from people with diverse backgrounds and experience to join this multicultural, hard-working team. Benefits Competitive salary and performance-based incentives Health, dental, and vision insurance 401(k) retirement plan Paid time off and holidays Professional development and career advancement opportunities A dynamic and growing team focused on innovation and excellence

Regeneron's Late-Stage Purification Development team within PMPD (Preclinical Manufacturing and Process Development) is seeking a full-time Process Development Associate. In this role, you will be responsible for the development and transfer of the harvest, affinity chromatography, and viral inactivation unit operations for recombinant proteins using Quality by Design principles. A Typical Day in the Role Might Look Like: * Designs and executes experiments at both bench and pilot-scale * Analyzes data, draws conclusions from results, and proposes next steps * Documents results in laboratory notebook and reports * Communicates findings to functional area and department leadership * Acts as purification development subject matter expert during manufacturing process transfer to ensure successful completion of GMP batches * Works cross-functionally with the process development team to enable a robust, cohesive manufacturing process * Supports technology development and improvement activities potentially including but not limited to: automation of pilot-scale unit operations, improving bench-scale process models, developing workflows for compilation and analysis of historical data, investigating new raw materials, equipment, and/or techniques to advance the harvest, affinity chromatography, and viral inactivation unit operations * Trains peers and directly or indirectly manages, mentors, and assists co-op students and interns in conducting experiments, analyzing data, and documenting results. * Contributes to lab equipment maintenance and general lab safety to help create a safe, effective, and efficient working environment This Role Might Be For You If You: * Have a solid understanding and practical experience in purifying monoclonal antibodies or other biopharmaceuticals * Enjoy spending ~50-70% of time performing lab work at both bench and pilot-scale * Have experience with process automation, specifically hardware, control logic, and/or HMI development * Thrive in a team-based, collaborative environment * Are well organized and able to manage multiple projects efficiently * Are an effective communicator within all levels of an organization * Are scientifically curious, creative, and have a problem-solver mentality This role requires a Bachelor's degree in either Chemical Engineering, Biochemical Engineering, Biochemistry, or a related field with 0 - 2 years of recombinant protein purification experience, including some but not limited to depth filtration, disc stack centrifugation, column chromatography, virus retentive filtration, ultrafiltration/diafiltration, buffer preparation. A strong fundamental understanding of various protein purification techniques and experience with Akta chromatography systems, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, Python, Ignition, and PI Historian is a plus. #pmpd Intro To PMPD Video: ****************************************************************************************** Intro To PMPD Purification Video: ****************************************************************************************** Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $70,300.00 - $110,100.00

Regeneron's Preclinical Manufacturing & Process Development Group (PMPD) is seeking a Process Development Associate as a full time position to work in the Purification Development group. In this role, you will be responsible for the purification at pilot scale of a variety of clinical biologics, building systems to support the planning and execution of pilot scale work, and investigating technologies to support the scalability of pilot scale operations. The ideal candidate will be hardworking, efficient, flexible, and able to perform key responsibilities in a fast-paced, team environment. This is a lab based role focused on pilot scale operations, requiring a significant amount of physical activity. A Typical Day in the Role Might Look Like: * An associate or engineer who is experienced in the general operations of a laboratory and/or functional area. Begins to manage and organize data more independently - has some decision making capability and works under supervision (daily or near daily). Participates effectively as a member of a "team" within his/her laboratory or functional area. Communicates with all levels of the organization. Executes experiments alone and/or in collaboration alone with others. Performs routine technical tasks, begins to manage, organize, and interpret data more independently, and presents results to his/her supervisor. Receives general instruction for routine work; more detailed instruction is provided for new projects. The ability to design experiments with proper controls. * Executes experiments/projects using established procedures. Performs basic data entry and analysis alone or in collaboration with others and recognizes unexpected results. Understands scientific method and experimental controls and works to perfect technique on the basics. Scientifically curious, enthusiastic, and proactively asks questions to learn or seek clarification * Reads and understands scientific literature and technical documentation. Executes experimental plans to verify literature findings with direction and prepares comparison of internal data to literature for review with manager. * Trains and becomes proficient in operations of job-relevant laboratory instrumentation and data systems. May have a role in knowledge/data management and be responsible for maintenance and service of lab/data resources. May assist in training new staff after demonstrating competency. * Will support technology development and improvement initiatives * May contribute to development of technology and automation to increase the throughput and speed of pilot scale operations. * Builds relationships within subgroup to support shared goals and may train peers and indirectly lead, guide, and assist co-op students/interns. Proactively assists others in execution of experiments and knows when to ask for help from peers. This Role Might Be For You If You : * Enjoy a fast paced pilot scale laboratory setting where sound science and team work are the priorities. * Contribute to lab equipment maintenance and safety to help create a safe, effective and efficient working environment. * Anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and tackle problems. * Can ensure training and/or compliance responsibilities are maintained. * Has experience in small to large scale manufacturing. The role requires A Bachelor's and/or Master's degree in either Chemical Engineering, Biochemical Engineering, or Biochemistry, and 1 - 5+ years' experience in the biotech or pharmaceutical industry. A strong fundamental understanding of various protein purification techniques is a plus. Experience with Downstream Development and with equipment like: Tangential flow filters, Normal flow filters, ultrafiltration/diafiltration skids, Akta chromatography systems, disc stack centrifuge, depth filtration, chromatographic columns, HPLC, UPLC, Empower, Unicorn, JMP, LIMS, PI Historian is a plus. Experience with raman spectroscopy and/or software programming is a plus. #pmpd Intro To PMPD Video: ****************************************************************************************** Intro To PMPD Purification Video: ****************************************************************************************** Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $70,300.00 - $110,100.00

The Engineering Intern at Cook Winston-Salem will be part of the Summer Internship Program. Paid internships at Cook Medical are offered for a period extending from mid-May through mid-August (Exact dates depend on school calendars.) All internships provide hands-on experience with meaningful projects in the Medical Device Manufacturing Industry. Responsibilities • Engineering CO-OPs may be involved in projects in the following areas: Equipment Application; Device Development; Manufacturing Support; New Technology Support and Development/ Process Control; Process Validation; Product Development; Quality Engineering; Project Engineering; Systems Support: Research and Technical Writing • Produce engineering deliverables/documents; Provide analysis of recommended solutions to any obstacles or problems during production • CO-OPs are assigned a direct mentor who provides a unique perspective of life at Cook. Mentors are chosen from Engineers and all mentors are responsible for guidance for their CO-OPs • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth Qualifications • College/University student entering Sophomore, Junior or Senior year the following Fall Semester or Graduate student enrolled in Engineering. • Minimum GPA of 3.0 is preferred. • All candidates must provide proof of enrollment in an accredited college or university Physical Requirements: • Works under general office environmental conditions • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc. • Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing •Occasionally lifting with minimal exertion during shift • Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position “Qualified candidates must be legally authorized to be employed in the United States without any need for current or future visa sponsorship. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this temporary position and will not consider candidates that have a future sponsorship need.”

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment. A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes. The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics. Position Responsibilities Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Position Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Sr. Supervisor Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 years' experience, or equivalent. 2+ years prior leadership/supervisory experience. Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. For Supervisor, prior experience in a leadership/supervisory role is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. MS Office, ERP, EDMS, production equipment software, other Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records; implement corrective and preventive actions (CAPAs); support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives. A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations. The Supervisor will have a working knowledge of bioprocessing equipment. including but not limited to, filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Supervisor will review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production documents to ensure accuracy and completeness. It is management's expectation that supervisors uphold the company's core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes. Job Responsibilities Support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures. Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Minimum Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Language Ability Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software is required Equipment Use Knowledge of and experience using upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment is required Working Conditions The job requires working 12-hour shifts (2-2-3 schedule) which include working weekends and holidays and may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (Supervisor) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely "Right First Time" execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment. A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes. The Sr. Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics. Position Responsibilities * Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. * Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. * Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. * Ensure timely corrections to batch documentation and logbooks. * Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. * Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. * Author, train, review manufacturing procedures * Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Position Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Sr. Supervisor * Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 years' experience, or equivalent. * 2+ years prior leadership/supervisory experience. * Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred. * Experience in single-use platform technology is preferred. For Supervisor, prior experience in a leadership/supervisory role is preferred. * Knowledge of quality systems and regulatory expectations is preferred. * Excellent written and verbal communication skills are required. * Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor * Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. * Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. * Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. * MS Office, ERP, EDMS, production equipment software, other * Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate (Attribute Sciences) What you will do Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR. Execute methods, author reports and ensure safety and compliance for all activities. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR Associate's degree and 2 years of Process Development / Chemistry or related experience OR Bachelor's degree Preferred Qualifications: Degree in Chemistry or related area. Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing. Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR). Experience in method transfers, method validation, and method troubleshooting. Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation. Effective oral and verbal communication skills. Technical writing skills and attention to details in documents. A self-starter and valuable teammate. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 79,971.00 USD - 89,221.00 USD

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Process Development Associate (Attribute Sciences)** **What you will do** Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. + Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing. + Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements + Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing + Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR. + Execute methods, author reports and ensure safety and compliance for all activities. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. **Basic Qualifications:** + High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR + Associate's degree and 2 years of Process Development / Chemistry or related experience OR + Bachelor's degree **Preferred Qualifications:** + Degree in Chemistry or related area. + Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing. + Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR). + Experience in method transfers, method validation, and method troubleshooting. + Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation. + Effective oral and verbal communication skills. + Technical writing skills and attention to details in documents. + A self-starter and valuable teammate. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

About Kriya

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America's Best Startup Employers of 2024,” and honored as one of BioSpace's “2025 Best Places to Work.” Role Overview The Engineer II, Manufacturing Systems is an experienced OT Automation and Manufacturing Engineer responsible for the administration, reliability, and continuous improvement of GMP-critical automation platforms including OSIsoft PI, Siemens Desigo CC, and DeltaV. As a key member of the Operational Technology Automation Manufacturing team, you collaborate with cross functional teams including Manufacturing, Facilities/Engineering, Quality and IT to deliver automation solutions that support production goals and regulatory compliance. Key Responsibilities Configure and maintain OSIsoft PI data historian infrastructure, including interface configuration, data collection optimization, and data archive management. Support Siemens Desigo CC building management system operations. Monitor system health and performance metrics across all automation platforms, proactively identifying and resolving issues to maximize uptime. Execute preventive maintenance activities, software patching, and system updates in accordance with change control procedures. Investigate and troubleshoot system alarms, faults, and performance degradation, implementing corrective and preventive actions. Support validation activities including IQ/OQ/PQ protocol execution, test script development, and documentation review for automation systems. Maintain system documentation including network diagrams, configuration specifications, standard operating procedures, and maintenance records Experience & Skills Bachelor's degree in Engineering (Chemical, Electrical, Mechanical, or related discipline) or equivalent technical degree Minimum 3+ years of experience supporting automation systems in pharmaceutical, biotechnology, or regulated manufacturing environments An equivalent combination of education and experience is acceptable Familiarity with industrial networking protocols (Ethernet/IP, Modbus, OPC, BACnet) and network infrastructure. Knowledge of validation lifecycle and IQ/OQ/PQ protocol execution for automated systems. Experience with the life cycle management of at least oneof the following systems in a GMP environment: Allen Bradley PLCs and FT View Emerson DeltaV or ThermoFisher TruBio OSIsoft Pi Data Historian System Tulip Management of Manufacturing Operations System Siemens Desigo Building Management System TiPSView Alarm Assessment System Proficiency with SQL databases and scripting languages (VBA, Python, or PowerShell) for automation tasks Strong analytical and problem-solving skills with ability to diagnose complex system issues. Effective communication skills for technical and non-technical audiences. Ability to work independently and as part of cross-functional project teams. Work Environment Primarily desk-based, generally in an office or home office setting Occasional tasks performed in a lab or manufacturing clean room environment. Must be able to lift desktop computers, small servers, switches, PLCs, and electrical components May be required to work after-hours for OT emergencies or maintenance window activities Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. Rewards & Benefits Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more! Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All job requirements in the provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 "Best Private Company to Work For," recognized by Forbes as one of "America's Best Startup Employers of 2024," and honored as one of BioSpace's "2025 Best Places to Work." Role Overview The Engineer II, Manufacturing Systems is an experienced OT Automation and Manufacturing Engineer responsible for the administration, reliability, and continuous improvement of GMP-critical automation platforms including OSIsoft PI, Siemens Desigo CC, and DeltaV. As a key member of the Operational Technology Automation Manufacturing team, you collaborate with cross functional teams including Manufacturing, Facilities/Engineering, Quality and IT to deliver automation solutions that support production goals and regulatory compliance. Key Responsibilities * Configure and maintain OSIsoft PI data historian infrastructure, including interface configuration, data collection optimization, and data archive management. * Support Siemens Desigo CC building management system operations. * Monitor system health and performance metrics across all automation platforms, proactively identifying and resolving issues to maximize uptime. * Execute preventive maintenance activities, software patching, and system updates in accordance with change control procedures. * Investigate and troubleshoot system alarms, faults, and performance degradation, implementing corrective and preventive actions. * Support validation activities including IQ/OQ/PQ protocol execution, test script development, and documentation review for automation systems. * Maintain system documentation including network diagrams, configuration specifications, standard operating procedures, and maintenance records Experience & Skills * Bachelor's degree in Engineering (Chemical, Electrical, Mechanical, or related discipline) or equivalent technical degree * Minimum 3+ years of experience supporting automation systems in pharmaceutical, biotechnology, or regulated manufacturing environments * An equivalent combination of education and experience is acceptable * Familiarity with industrial networking protocols (Ethernet/IP, Modbus, OPC, BACnet) and network infrastructure. * Knowledge of validation lifecycle and IQ/OQ/PQ protocol execution for automated systems. * Experience with the life cycle management of at least oneof the following systems in a GMP environment: * Allen Bradley PLCs and FT View * Emerson DeltaV or ThermoFisher TruBio * OSIsoft Pi Data Historian System * Tulip Management of Manufacturing Operations System * Siemens Desigo Building Management System * TiPSView Alarm Assessment System * Proficiency with SQL databases and scripting languages (VBA, Python, or PowerShell) for automation tasks * Strong analytical and problem-solving skills with ability to diagnose complex system issues. * Effective communication skills for technical and non-technical audiences. * Ability to work independently and as part of cross-functional project teams. Work Environment * Primarily desk-based, generally in an office or home office setting * Occasional tasks performed in a lab or manufacturing clean room environment. * Must be able to lift desktop computers, small servers, switches, PLCs, and electrical components * May be required to work after-hours for OT emergencies or maintenance window activities Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. Rewards & Benefits Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more! Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All job requirements in the provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

We are seeking a charismatic and dynamic engineer to join our technical team at the Niagara Falls Ceramics Plant! The engineer provides engineering and consulting support to maintain and develop products or processes and manages technical information flow for the same. Primary accountability is to support both commercial and manufacturing in the Armor product line. This includes active contact with the customer regarding product requirements and translation of these requirements into product definition. Takes into account effective use of materials and resources and recommends changes to product specifications as necessary. The engineer will provide technical service support to the sales organization to solve customer needs and product or processes problems for the purpose of maintaining and increasing sales. The engineer works within an engineering group that provides technical support and development throughout the business organization. The engineer is expected to take advice from and give advice to the senior technical and production managers, as well as function as technical expert for associates within operations, as well as the commercial team. The engineer will serve as the technical team leader for the specified product line. Product Applications may be found in multiple arenas, some of which are untouched and, in their infancy, developing and utilizing Armor products. The incumbent must continue to develop current awareness of innovations, customer processing systems, and future expansion plans in diverse industries, in order to assist the commercial team in responding to increasing sales opportunities. The incumbent manages key Armor programs to successful completion as the direct technical interface between the commercial team and internal operations (Manufacturing, R&D, Customer Service) and acts as the primary interface/liaison between Engineering, Customer Service, R&D, Operations, and Commercial teams for Armor products. This role will require frequent visits to customers as well as hosting visits in support of the Armor commercial team. The most successful candidate will have a strong interest in customer relations and sales. IS THIS JOB FOR YOU? Education: Bachelor's Degree in Ceramic or Materials Engineering is required. Experience: 1+ years of experience in a manufacturing setting is required. 3+ years of experience in ceramic manufacturing is preferred. A TEAM READY TO WELCOME YOU Who are we? A strong international group company's Performance Ceramics & Refractories (PCR) leads the industry in the design, development and manufacturing of the highest performing solutions for extreme operating conditions. We strive to deliver value through our global technical expertise and the long-term partnerships we form with our customers. Our employees are committed to delivering the best solutions and services to meet the unique material and engineering needs of our customers. Ceramic & refractory solutions for broad industrial applications provide an end-to-end solution for your business. Our performance ceramic (advanced / fine ceramic) solutions cover industrial kiln & furnaces, specialty ceramics, burner solution for industrial heating, wear resistance applications (mining, bulk handling in iron & steel making), wine & beer filtration, industrial filtration, Armor, metrology, labware, and many more demanding applications which rely on high performance ceramic material characteristics. Our performance refractory solutions are designed and manufactured to overcome operational challenges in metallurgical applications. Refractory bricks, tiles, castable and mortars for every equipment are used for ironmaking, steelmaking, primary aluminium, copper, zinc galvanizing, foundry, carbon black, petrochemicals, and also Waste-to-Energy (WtE). At the company we design, manufacture and distribute materials which are key ingredients in the wellbeing of each of us and the future of all. Join our innovative, passionate and entrepreneurial community to improve the world of tomorrow with us. The candidate will, generally, perform the following duties: Identify customer needs and, in close cooperation commercial team, adapt existing products and services to meet those needs within the framework of our capabilities; understand the current applications and products and can serve as the expert and the reference in the application for our customers. Work with the process engineers across all plant departments, and the commercial team, in trouble shooting customer issues. Show continuous improvement in product or process development by improving manufacturing processes: developing ways to reduce scrap and rework, increase productivity/efficiency and decrease operating costs. Initiate and maintain Engineering Change Notices (ECN) to document and control changes in specifications, processes, and procedures. Act as a technical support to the manufacturing floor for the Armor product line and work to solve assigned engineering problems including checking the work of others within relevant departments. Manage assigned projects, engineering trials and prototype builds including project scheduling, performance, implementation, and writing reports in coordination with requested completion dates. Participate in all Armor customer calls and visits alongside commercial team, and attend trade shows and visit customers as required. What are our Perks? Excellent Healthcare: Medical, vision, prescription & dental Family Focus & Balance: Parental leave, paid time-off and Employee Assistance Program Financial Security: Competitive 401(k), Company-funded Retirement Accumulation Plan and Employee Stock Purchase Program (PEG) Tuition Reimbursement: Continuing education for every season of your career Pet Insurance options: Insurance plan & prescription discount program for your furry friends PerkSpot: Our exclusive one-stop online discount marketplace LiveWell: Rewarding you for living a healthy lifestyle MUST HAVE Bachelor's Degree in Ceramic or Materials Engineering is required. 1+ years of experience in a manufacturing setting is required. NICE TO HAVE 3+ years of experience in ceramic manufacturing is preferred. Package Details Excellent Healthcare: Medical, vision, prescription & dental Family Focus & Balance: Parental leave, paid time-off and Employee Assistance Program Financial Security: Competitive 401(k), Company-funded Retirement Accumulation Plan and Employee Stock Purchase Program (PEG) Tuition Reimbursement: Continuing education for every season of your career Pet Insurance options: Insurance plan & prescription discount program for your furry friends PerkSpot: Our exclusive one-stop online discount marketplace LiveWell: Rewarding you for living a healthy lifestyle

Aerospace Engineer Position Type: Full-time (ON-SITE) Chantilly, VA Clearance Required: TS/SCI w/CI Poly Waypoint's client is seeking a highly motivated and skilled Aerospace Engineer to join their team supporting a critical government client. This position offers the opportunity to support RDT&E for cutting-edge projects supporting space-based systems. Responsibilities: Develop and maintain physics-based simulation models of spacecraft systems, including structures, sensors, and mission environments. Perform end-to-end performance modeling for satellite missions, integrating sensor, orbital, and environmental models. Conduct sensor phenomenology studies, including optical, infrared, or radar modeling for detection, tracking, and signature analysis. Perform orbital mechanics modeling including orbit determination, orbital maneuvering, and spacecraft flight dynamics Use scripting languages (Python, MATLAB, or similar) to automate workflows, perform data analysis, and interface between simulation tools. Required Qualifications: Bachelor's or Master's degree in Aerospace Engineering, Mechanical Engineering, Physics, or a related field. 3+ years of experience in modeling and simulation for aerospace or space systems. Active Top Secret/SCI w/Poly Clearance Strong understanding of sensor phenomenology-such as optical, infrared, or radar systems-and associated modeling methods. Intermediate Python programming experience, demonstrated through hands-on experience with tasks such as data manipulation, automation, and development of Python-based solutions. Experience with libraries such as NumPy, SciPy, pandas, and matplotlib is beneficial. Ability to communicate technical results clearly in both written and verbal formats. Preferred Qualifications: Master's degree in a STEM related field. 6+ years of related experience. Experience with other simulation tools and programming languages. Experience with non-cooperative target tracking. Experience with collection & revisit modeling. Knowledge of cloud computing platforms (e.g., AWS, Azure).