Reliability engineer jobs in Raleigh, NC - 274 jobs

Responsibilitiesarrow_right * Failure Analysis & Maintenance Strategy: Diagnose equipment issues and optimize performance using CMMS, predictive tools, and root cause analysis. * Technical Drawing & Documentation: Create detailed engineering drawings with AutoCAD and Inventor, and produce professional deliverables like project scopes and executive presentations. * Systems Troubleshooting & Safety Engineering: Apply expertise in electromechanical and industrial control systems to resolve machine issues and enhance safety through equipment redesign. * Project Leadership & Capital Execution: Support Capex and Maintenance initiatives from concept to closeout using the full capital engineering stage-gate process. * Procurement & Vendor Coordination: Collaborate with third-party vendors to outsource fabrications, manage part procurement, and create SAP requisitions. * Predictive Monitoring & Reliability Support: Monitor critical equipment health using vibration analysis and thermal imaging, and assist in developing long-term reliability strategies. Qualificationsarrow_right * Bachelors degree in Mechanical Engineering * 3-10 years of reliability, maintenance, or process engineering experience in a manufacturing environment * Knowledge of controls and instrumentation/SCADA and AutoCAD * Self-starter with strong communication skills * Reliability or Project Management Certifications (CMRP, CRL, PMP) or Six Sigma Green/Black Belt are a plus

We are Reckitt Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Supply Our supply chain is the backbone of our business. It's how we get our trusted products to people all over the world, safely and efficiently. And it's our talented and passionate teams that make this happen. If you're looking for a career in supply chain, there's no better place to be than Reckitt. We offer a variety of exciting opportunities in all areas of the supply chain, from planning and procurement to manufacturing and logistics. You could join our Global Supply Planning team to develop and implement our global supply strategy, or work with our Procurement Centre of Excellence team to negotiate and manage our supplier relationships. Our Manufacturing Excellence team help us improve the efficiency, quality and safety of our manufacturing operations, and our Logistics Excellence team develop new and innovative ways to distribute our products to customers. About the role The Reliability & Maintenance Engineer is responsible for developing, implementing, and optimizing maintenance and reliability strategies to ensure safe, efficient, and sustainable operation of manufacturing assets in a GMP-regulated facility. This role focuses on equipment performance analysis, preventive and predictive maintenance programs, spare parts criticality assessment, and continuous improvement initiatives. The Engineer collaborates with production, quality, and maintenance teams to minimize downtime, extend asset life, and ensure compliance with regulatory and safety standards. Your responsibilities Reliability Engineering * Analyze equipment performance data to identify trends, failure modes, and root causes. * Develop and implement reliability-centered maintenance (RCM) strategies to improve mean time between failures (MTBF) and reduce mean time to repair (MTTR). * Lead or support root cause analysis (RCA) for equipment-related deviations or failures. * Recommend engineering solutions to enhance equipment reliability and optimize lifecycle costs. Maintenance Planning & Execution * Develop, implement, and optimize preventive and predictive maintenance (PM/PdM) strategies for OSD equipment, including granulators, fluid bed dryers, tablet presses, coaters, dust collection systems, and packaging lines. * Develop detailed job plans including material lists, labor estimates, and safety requirements. * Coordinate with maintenance staff and contractors to ensure timely execution of planned work. * Track and report maintenance KPIs such as uptime, backlog, and work order completion rates. Spare Parts Criticality & Inventory Management * Conduct spare parts criticality assessments to determine which components are essential for equipment reliability and production continuity. * Classify spares into categories (critical, essential, non-critical) based on risk, lead time, and equipment impact. * Collaborate with storeroom and procurement teams to ensure availability of critical spares while optimizing inventory costs. * Evaluate repair vs. replacement decisions to balance reliability and cost-effectiveness. * Support kitting and staging of materials for planned jobs, prioritizing critical spares. * Ensure accuracy of asset hierarchies, BOMs, spare parts lists, and maintenance task plans Compliance & Safety * Ensure all maintenance and engineering activities comply with OSHA, GMP, and company safety standards. * Partner with Quality Assurance to support audits, deviations, CAPAs, and change controls. * Participate in risk assessments, LOTO procedures, and confined space protocols. Continuous Improvement * Identify opportunities to eliminate delays and improve maintenance efficiency. * Integrate predictive maintenance technologies (condition monitoring, vibration analysis, thermography). * Drive initiatives aligned with site goals such as OEE improvement and proactive maintenance models. * Support capital projects and equipment upgrades to enhance reliability. * Partner with Engineering on equipment upgrades, replacements, FAT/SAT, commissioning, and qualification. This role is not currently sponsoring visas or considering international movement at this time. The experience we're looking for * Associate's degree in a mechanical, electrical, industrial, or related technical field; bachelor's degree preferred * 3-5+ years of experience in maintenance engineering, reliability, or asset management within manufacturing, including pharmaceutical, chemical, food, or industrial environments * Strong knowledge of mechanical and electrical systems, reliability engineering principles, precision maintenance tools, PLCs, automation, and controls * Proficiency with CMMS systems, SAP, Microsoft Office, data analysis tools, and reliability analysis software * Experience with preventive and predictive maintenance programs, spare‑parts criticality analysis, and inventory optimization * Strong analytical and problem‑solving abilities, including root‑cause analysis * Effective communication and collaboration across technical and non‑technical teams * Ability to manage multiple projects, prioritize effectively, and work in dynamic environments * Knowledge of GMP documentation systems and regulatory compliance * Ability to evaluate spare‑parts criticality, balance reliability with cost efficiency, and track performance metrics to drive maintenance improvements. What we offer With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy. US salary ranges USD $88,000.00 - $132,000.00 Hiring Range up to 110K US pay transparency The base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law. In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year. Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, and life and disability insurance; paid time off for vacation, sick and Company recognized holidays; a 401(k) plan; 16-week paid parental leave or 26 weeks for the birthing parent; adoption and fertility support; tuition reimbursement; discounts; and much more. Our compensation and benefits packages aim to give our talent the reward, protection, and peace of mind they deserve. If reasonable accommodation is needed to complete your application, please contact *******************************. Reckitt is committed to the full inclusion of all qualified individuals. Equality We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. Nearest Major Market: Raleigh Nearest Secondary Market: Rocky Mount Job Segment: Counseling, Nutrition, Healthcare

Working at Freudenberg: We will wow your world! Responsibilities: Failure Analysis & Maintenance Strategy: Diagnose equipment issues and optimize performance using CMMS, predictive tools, and root cause analysis. Technical Drawing & Documentation: Create detailed engineering drawings with AutoCAD and Inventor, and produce professional deliverables like project scopes and executive presentations. Systems Troubleshooting & Safety Engineering: Apply expertise in electromechanical and industrial control systems to resolve machine issues and enhance safety through equipment redesign. Project Leadership & Capital Execution: Support Capex and Maintenance initiatives from concept to closeout using the full capital engineering stage-gate process. Procurement & Vendor Coordination: Collaborate with third-party vendors to outsource fabrications, manage part procurement, and create SAP requisitions. Predictive Monitoring & Reliability Support: Monitor critical equipment health using vibration analysis and thermal imaging, and assist in developing long-term reliability strategies. Qualifications: Bachelors degree in Mechanical Engineering 3-10 years of reliability, maintenance, or process engineering experience in a manufacturing environment Knowledge of controls and instrumentation/SCADA and AutoCAD Self-starter with strong communication skills Reliability or Project Management Certifications (CMRP, CRL, PMP) or Six Sigma Green/Black Belt are a plus The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Performance Materials LP (USA)

We are seeking an experienced Process Engineer with a minimum of 3 years of experience, ideally within filling operations. The ideal candidate will have a strong background in biotech engineering and be able to effectively communicate and coordinate with various teams. Responsibilities of the Process Engineer: * Oversee area content and provide process knowledge, periodic reviews, validation processes, and reporting. * Demonstrate technical knowledge of assigned processes to promote continuous improvement, increased productivity, and cost reduction. * Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation, and process changes/improvements. * Evaluate process/maintenance data to propose, guide, and evaluate solutions for changes and continuous process improvements via Lean tools and Six Sigma methodologies. * Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter. * Collaborate and share best practices with other departments and other sites of NN. * Provide support to other areas in matters related to knowledge of assigned production/process area. * Identify and implement process needs and improvement opportunities for issues of all complexity levels as SME for assigned areas. * Implement new technologies for the process, planning, and coordinating of changes according to applicable regulatory procedures. * Follow all safety and environmental requirements. Qualifications of the Process Engineer: * Minimum 3 years of biotech experience, ideally within filling operations. * A Bachelor's degree in Electrical Engineering, Mechanical Engineering, or Chemical Engineering (in order of preference). Compensation of the Process Engineer: * Compensation: $80,000 - $90,000 * Benefits: Health, Dental, Vision, and sick leave as required by law Application Details: This job opens for applications on 7/2. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: biotech, engineer, filling operations, process improvement, Lean, Six Sigma, validation, root cause analysis, regulatory compliance, safety, environmental requirements #LI-ONSITE #LI-KI1

Job DescriptionDescription: The Process Engineer is a hands-on role responsible for developing, optimizing, and troubleshooting injection molding processes to ensure high-quality plastic components. This position supports new product launches, continuous improvement initiatives, and technical problem-solving across molding operations. Job Responsibilities: This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities as management may deem necessary at any time. Initial Process development on all new tooling. Run and monitor the cycle time reduction program. Document all processes and sample findings. Troubleshoot existing production issues, driving to a robust solution. Participate in Mold design reviews. Set sample tooling and prepare work cell. Analyze problems with new tooling start-up and propose solutions. Research new technologies for manufacturing as needed. Perform DOE's Perform other duties as required. Requirements: Knowledge, Skills and Abilities: Bachelor's degree in Plastics or Engineering (or equivalent experience). 3-5+ years in plastic injection molding process engineering Hands-on experience with mold setup, troubleshooting, and validation in scientific molding. Proficiency in statistical analysis and process control. Proficiency with Microsoft programs Excellent problem-solving, communication, and organizational skills. Familiarity with RJG or similar process monitoring systems is a plus.

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a skilled and experienced Process Engineer III/ IV with deep expertise in small molecule manufacturing to join our engineering consulting team. This role combines technical leadership with strategic client engagement, supporting process design, scale-up, optimization, and regulatory compliance across a variety of pharmaceutical and chemical industry projects. The Process Engineer III will lead the design and execution of process scopes-such as unit operations, systems, or facility areas-on small to medium-sized projects. You will manage scope, budget, and schedule, while maintaining clear communication with clients and internal teams. This role also includes mentoring junior staff, contributing to high-quality deliverables, and supporting capital project planning and regulatory alignment. This position can be based near any CRB location Key Responsibilities * Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization. * Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance. * Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances. * Translate client requirements into actionable design scope and document decisions, open issues, and action items. * Identify and escalate scope changes or design deviations to project leadership. * Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction. * Prepare technical reports, proposals, and presentations for internal and client stakeholders. * Support capital project planning including feasibility studies, equipment selection, and facility design. * Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines. * Participate in advanced project activities such as: * Technical bid tabulations * Vendor package management * Factory acceptance testing * Risk assessments (e.g., HAZOP, HACCP) * 3D model reviews and coordination * Sequence of operations and functional specification reviews * Mentor junior engineers and design staff. * Lead system design programming and planning with support from senior engineers. * Participate in cross-discipline squad checks and drive overall project quality. Qualifications Minimum Qualifications * Bachelor's or Master's degree in Chemical Engineering or a related discipline (ABET-accredited). * Minimum of 5 years of experience in small molecule process engineering, preferably in a consulting or client-facing role. * Strong understanding of chemical synthesis, purification, and formulation processes. * Experience in design firm or operating company settings within a related industry. * Strong written and verbal communication skills. * Intermediate experience with applicable industry and regulatory guidance and building codes. * Advanced technical knowledge and experience with small molecule API manufacturing equipment and utility systems, such as chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water, process compressed gases, and engineered heat transfer fluid systems. * Experience designing and implementing engineering controls for containment of highly potent APIs. * Experience with cGMP practices within regulated industries (FDA, EMA, JP, etc.). Preferred Qualifications * EIT or PE certification. * Experience coordinating and managing design within project teams and with external partners. * Familiarity with commissioning, startup, qualification, and troubleshooting of process systems. * Experience with regulatory environments and validation documentation. * Prior experience in engineering consulting or client services. * Familiarity with process safety, risk assessments, and HAZOP studies. * Demonstrated experience leading a small team of process engineers on complex engineering design projects. Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Do you enjoy hands-on work? Do you like solving puzzles? Are you motivated by seeing your contributions come to life? Our manufacturing team specializes in supporting the lifecycle of our machines and products. Our team is dedicated to consistency, fit, finish, machine integrity, and manufacturing excellence. We offer rewarding, challenging opportunities throughout the world, across multiple packaging segments. If you are detail-oriented and focused on continuous improvement, we want to talk to you. Do we have your attention? Keep reading. Axon has an immediate need for a Process Engineer who will play a critical role in leading the standardization and ongoing maintenance of our machine Bill of Materials (BOM), while streamlining our assembly processes, driving product line standardization, and collaborating with vendors to maximize purchasing power. This position reports to Axon's Engineering Manager. Are you passionate about this work? Standardize and maintain BOMs: Develop, implement, and oversee standardized machine BOMs across product lines to ensure accuracy, consistency, and efficiency. Process improvement leadership: Apply Six Sigma methodologies to identify inefficiencies, reduce waste, and optimize assembly workflows. Work instruction development. Cross-functional support: Work closely with engineering, operations, and procurement teams to ensure BOM accuracy and process alignment. Continuous improvement culture: Champion best practices, train team members, and foster a culture of operational excellence. What's in it for you? There's no monopoly on innovative ideas or limits to how far you can advance with our team. We offer an open, communicative environment that fosters individual initiative. We pride ourselves in being a company where people are happy and choose to build a career. In addition to growth opportunities, as a ProMach employee, you receive more than just a paycheck. Total compensation includes your salary, comprehensive medical/dental programs, as well as life insurance, a generous paid time off program, and a retirement savings plan with a company match. And because we understand the importance of feeling protected, there is no waiting period for benefits - you are eligible on your first day of employment! Please note that the pay ranges listed on external job boards, outside our posting details, do not accurately reflect our internal compensation ranges. If this sounds like you, we want to connect! Six Sigma training/certification. Experience with BOM management utilizing ERP inventory systems in a manufacturing or assembly environment. Analytical mindset with proficiency in data-driven decision-making and reporting tools. Collaboration and communication skills to work effectively across departments and with external partners. Bachelor's degree in Engineering, Supply Chain, Operations Management, or related field preferred. Pro Mach, Inc. was named to the Inc. 5,000 list of the fastest growing private companies in the U.S. seven times. We continue to introduce innovative products, enter new markets, expand our global presence, and actively acquire new capabilities. We have the rewards, opportunities, and the market strength of a large organization combined with the entrepreneurial culture of a small, fast-paced company. You will enjoy the benefits of working with a growing company that competes globally, with the personal touch and feel of a smaller company where you can make an impact every day. Curious about life at ProMach? Follow us on LinkedIn, Twitter, and Instagram! ProMach is an Equal Opportunity Employer. Pro Mach uses E-Verify to verify employment eligibility of all new hires to work in the United States. Pro Mach is a drug-free workplace. 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. Please note that the pay ranges listed on external job boards, outside our posting details, do not accurately reflect our internal compensation ranges. #AXON

Apply now " Job Type: Long-term / Regular At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. WHAT WE ARE LOOKING FOR The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance with Guerbet requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Supports team members to ensure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. IPQE III Associates are expected to function with a moderate level of oversite from the department manager. YOUR ROLE * Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations. * Perform required QA inspections; i.e Sample defect detection. * Ability to participate in internal audits, as requested. * Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review. * Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing. * Assist personnel in the generation of operations/packaging area related exceptions. * Have the ability to support minor exceptions and simplified CAPAs and support phase II manufacturing investigations. * Attend daily operations staff communication meetings. * Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling. * Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as area inspections pre/post activity. * Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management. * Ability to support the QA label release functions on an as needed basis. * Maintain active communication with customers to facilitate continuous process improvement. * Identify, initiate, and implement process improvements within the Manufacturing and Quality areas. * Oversee departmental projects to ensure associated timelines are met ahead of schedule. * Ability to pass visual acuity exam for production and identification of quality product purposes. Department Specific/Non-Essential Functions: * Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. * Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. * Report all safety and/or environmental incidents to management immediately. * Other duties as assigned with or without accommodation. YOUR BACKGROUND * Associates degree in Science/Business preferred or equivalent industry experience. * Bachelor's degree in life sciences is a plus. * Minimum 8- 10 years of experience in a pharmaceutical QA/MFG environment is desired. * ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred). * Previous experience in investigation root cause analysis and/or writing (preferred). * Skilled competency with computers, MS Office software required. * Experience with pharmaceutical CAPA and Documentation systems (e.g., Track wise, Metric Stream, etc.) is preferred. We offer continued personal development. When you join Guerbet, you: * Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, * Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, * Are joining a company where we value diversity of talents coming from various horizons. Do you want to help improve patients' lives with us? We look forward to meeting you and continuing our story together! We # Innovate # Cooperate # Care #Achieve at Guerbet. Guerbet is a signatory of the Diversity Charter. We believe diversity is a source of strength, and all our positions are open to everyone. Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants. Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process. Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

Job Description The Spear Group Full-Time Opportunity with Corporate Benefits Project Engineer - Pharma Greenfield Project - Drug Product Manufacturing/Process Engineering Position starts full time on site in the Greater Philadelphia, PA Area during design until approx., June 2026 (design phase work in PA w/ travel expense coverage) Position Summary: The Spear Group has an exciting career opportunity for an experienced and knowledgeable Pharma Manufacturing Process Engineer / Project Engineer to support our top tier, global pharma manufacturer client with their greenfield project in the Raleigh/Durham NC area. This is a great opportunity to be on a greenfield project end to end starting with detailed design. The ideal Project Engineer will provide project engineer support in executing the delivery of core drug product unit operations / facilities (i.e. Compounding, Buffer Prep, CIP/SIP, Syringe Filling, Automated Visual Inspection, Equipment Prep, and Analytical Equipment) to the client's greenfield project during detailed design phase at a site outside of Philadelphia, PA and at the project site location in the immediate Raleigh/Durham, NC area. The selected Project Engineer is expected to be on-site at the designated project co-location site in the greater Philadelphia, PA area until thru June 2026, then to the designated project co-location site in Holly Springs, North Carolina thereafter for the duration of the assignment. Corp pharma client travel process will facilitate travel to PA. Key Responsibilities: Be the Owner's Rep on behalf of the pharma client's project engineering delivery team. Work closely with the core project team throughout the project phases of the project until completion of equipment and automation C&Q confirming core processing equipment and facilities are aligned with IFC drawings and other design documents. Activities may include, yet are not limited to the following: Attending equipment design meetings with equipment vendors Responding to equipment vendor submittals to ensure compliance with project design drawings, specifications, and user requirements. FAT execution, write-up, and review using existing documentation and protocols. Coordinate process equipment receipt verification. Working with internal and external pharma client/owner's project partners to ensure activities related to the core processing systems equipment installation and startup are aligned with the design. Equipment start-up and troubleshooting. Equipment and related clean utility C&Q execution, write-up and review using existing documentation and protocols. Turn over package (TOP) management. Deviation management. Equipment installation support and coordination with project General Contractor and Construction Manager Analytical equipment procurement, installation, start-up, and C&Q. Work with pharma client/owner Automation engineering team to facilitate coordination of control systems design, installation, and commissioning needed for the core processing systems. Vendor document and change requests management. The following process systems are in the Scope of Service: Buffer Prep, Compounding, filling tanks Utility Panel associated with the Compounding and Filling area Syringe Filling System Automated Visual Inspection System CIP/SIP Analytical and benchtop equipment Hours of work: 40 hours a week at the co-location site in the greater Philadelphia, PA area. After June2026, travel expenses to PA will not be needed as work will be at the facility project site in North Carolina and full time work presence will be in NC. Travel to be facilitated and approved by pharma client / owner's travel policy process. Required Experience and Education: Bachelor of Science Degree in chemical engineering or mechanical engineering or related engineering. 4-10 years of experience in pharmaceutical manufacturing CAPEX projects, Drug Product manufacturing, or device and packaging Compensation based on relevant experience EQUAL OPPORTUNITY EMPLOYER The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

Client: Brevitas Corp. Our Global Company, Brevitas Corp., is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage, Chemicals, and Information Technology. We are looking for a highly motivated and energetic individual to join our team as a Process Engineer. This job is in the United States and only candidates eligible to work in the U.S. for any employer will be considered. By applying to this job, your profile will be considered for upcoming roles within the next 1\-6 months when opportunities do arise. Responsibilities: Resolve technical issues with the equipment as it pertains to the process requirements, optimize and improve the process equipment, identify root cause for deviations, define corrective and preventative actions and implement new or replacement equipment as required. Support or lead system change requests associated with the validated equipment or systems. Prepare required documentation\/packages for process equipment and cleaning systems in preparation for regulatory inspections or audits. Provide equipment engineering support of pharmaceutical manufacturing equipment for new facility. Develop preventative and predictive maintenance plans for process systems to attain the highest reliability. Responsible for reliability and readiness of process equipment and systems to ensure operational efficiency. Assist in developing procedures for operating and maintenance for process equipment. Support or lead FAT, SAT, commissioning and qualification activities for new or modified systems. Offer critical assistance of harvest equipment includes tanks, centrifuges and harvest filtration skids, cleaning equipment and other support systems such as CIP and COP. Perform all work in accordance with all established regulatory, compliance, safety requirements and good engineering practice. Qualifications: Process engineering with demonstrated CAPEX experience in the pharmaceutical industry. Must have experience in upstream\/downstream bioprocesses and equipment. Working knowledge of PFD, P&I Diagrams, Mass Balance and be able to perform engineering calculations. Should be proficient in technical writing. Bachelor Degree in Chemical Engineering or equivalent discipline. High level of familiarity with Excel, Word, Access required. To Apply: Click the “I’m interested” button below, or E\-mail your resume in MSWord or pdf format to ************************ with the following details in the e\-mail's Subject Line: US \- Process Engineer: FIRST NAME, LAST NAME. We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job requirements. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. ​ Review our Candidate Privacy Policy for more information. "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"616249959","FontFamily":"PuviRegular","job OtherDetails":[{"field Label":"Work Experience","uitype":2,"value":"Intermediate (5 to 8 years)"},{"field Label":"Industry","uitype":2,"value":"Pharma"},{"field Label":"City","uitype":1,"value":"Raleigh"},{"field Label":"State\/Province","uitype":1,"value":"North Carolina"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"14260"}],"header Name":"US \- Process Engineer","widget Id":"**********00072311","is JobBoard":"false","user Id":"**********00115003","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":false,"job Id":"**********16107397","FontSize":"15","location":"Raleigh","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"1abnf612ff1527eea46d6ac81af73dd22a05f"}

CoVar is a small AI/ML R&D software company in Durham, NC, that uses artificial intelligence to solve problems that matter. We develop AI/ML tools to help the DoD detect enemies and threats, help biomedical researchers find new cures for diseases, and help monitor machinery to prevent injuries and environmental catastrophes. We are passionate engineers, dedicated to pushing the bounds of what AI/ML can do in the real world. About this position You will help CoVar develop signal processing algorithms and software to solve real-world customer problems. You will develop novel and advanced algorithms for sense making and sensor decision making for applications in the RF domain to include detection, localization, classification, tracking and EW. You will design and implement simulations for these RF applications as well as evaluate results on real world data. You will have the opportunity to present your work to high-level customers in the DoD and in the industry. The position includes opportunities to publish novel work in both classified and unclassified settings. Key Responsibilities Algorithm Development: Design, implement, and optimize signal and array processing algorithms for RF applications, detection, localization, tracking, channel estimation, beamforming, and spectral analysis. Data Analysis: Process and interpret RF datasets for signal detection, classification, tracking, parameter estimation, and pattern recognition. Prototyping & Testing: Develop simulation models (e.g., Python, MATLAB) and implement algorithms on real-time platforms such as FPGAs, GPUs, or SDRs (Software-Defined Radios). RF System Integration: Collaborate with hardware engineers to integrate digital signal processing (DSP) algorithms into RF systems and ensure optimal end-to-end performance. Performance Evaluation: Conduct laboratory and field testing to validate system performance under various operational conditions. Research & Innovation: Stay up to date with emerging RF technologies, advanced signal processing techniques, and industry best practices. Documentation: Prepare technical reports and presentations for internal and external stakeholders. Minimum qualifications B.S., M.S., or Ph.D in Electrical Engineering, Computer Engineering, Applied Physics, Applied Mathematics, or a related field. 3+ years of experience in RF signal processing or a related discipline. Strong proficiency in one or more of the following programming languages: Python, C/C++, or MATLAB. Experience in the following areas: RF signal processing, electronic warfare, optimization, array processing, machine learning, adaptive signal processing, AI/ML algorithm development, radar modeling, RF propagation Ability to work with cross-functional engineering teams and clearly communicate complex technical concepts. Ability to work in Durham, NC (relocation assistance available) Eligibility for US security clearance Preferred qualifications Experience with: Radar signal processing in Department of Defense (DoD) specific applications including electronic warfare (EW) techniques such as electronic support measures, attack, protection, and cognitive EW. AI/ML algorithm design in the areas of computer vision, reinforcement learning (RL), and natural language processing. Spectrum monitoring and signal classification using machine learning techniques. Translating the mission needs of DoD customers into an end-to-end technical solution. Proposal development and proposal writing. Familiarity with FPGA or GPU acceleration for high-performance DSP. Proficiency in C/C++ for embedded or real-time applications. Active U.S. security clearance. Benefits Competitive salary, cash bonus, equity structure, and 401k with employer contributions Excellent health care coverage, including dental and vision plans Flexible work schedule Tuition support Visit us: *************

Armacell provides numerous and diverse career opportunities. Add your talent to ours and make a difference around the world! As a Quality Process Engineer, you'll play a key role in ensuring our products meet the highest quality standards - from development through manufacturing. You'll collaborate with cross-functional teams to drive continuous improvement, lead root cause analysis, and support key quality initiatives to ensure customer satisfaction. What Armacell can offer you Healthcare benefits including medical & prescription drug coverage, dental, vision, and mental health & wellbeing. Financial programs such as 401(k), life insurance, short & long- term disability coverage, and opportunities for performance-based salary incentive programs Generous paid time off including 12 holidays and at least 120 hours PTO Training and educational resources on our personalized learning management system Giving & volunteer opportunities, and discounts on retail products, services & experiences Key Responsibilities Co-lead the World Class Manufacturing (WCM) Quality Pillar (QPC). Promote and adhere to all safety standards in lab and plant environments. Manage document and data control processes. Administer the PPAP (Production Part Approval Process) program as required. Lead data-driven problem solving and root cause analysis initiatives. Maintain the Material Review Board and manage nonconforming materials. Track and report monthly quality performance metrics. Monitor and improve processes related to customer satisfaction. Lead and process corrective/preventive actions within the plant. Serve as an internal ISO 9001:2015 auditor and support annual audits. Conduct Gage R&R studies and capability analyses. Understand and apply customer-specific quality requirements. Co-lead Product Conformity Audits and maintain documentation in DCT. Conduct annual product testing and manage customer certifications. Oversee raw material certifications and incoming material data entry. Coordinate outsourced testing and UL certifications. Manage collection and shipment of sales samples. Administer AIMS setup, label databases, and quality document systems (e.g., Qualtrax). Support other quality projects as assigned. Qualifications Bachelor's degree in Engineering or Chemistry (required) 3+ years of quality assurance experience in a manufacturing setting Strong analytical, problem-solving, and communication skills Able to thrive in a global, cross-functional team environment Self-motivated with the ability to manage multiple tasks in a fast-paced setting Proficiency in Microsoft Office and quality systems Familiarity with SPC (Statistical Process Control) and world-class manufacturing tools Experience with rubber processing (mixing, curing, extrusion, foaming) is a plus Proven leadership and project management capabilities Must be authorized to work in the U.S. without sponsorship The expected compensation range for this role is $80,000.00 -$95,000.00. The compensation range and benefits for this position are based on a full-time schedule for a full calendar year. The salary will vary depending on your job-related skills, experience, and location. Pay increment and frequency of pay will be in accordance with employment classification and applicable laws. For part time roles, your compensation and benefits will be adjusted to reflect your hours. Benefits may be pro-rated for those who start working during the calendar year. Armacell does not accept unsolicited resumes from individual recruiters or third-party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers or HR team. In order to provide the best experience for all stakeholders, we limit the number of agencies and recruiting vendors we partner with. If you would like to be considered for a particular search or added to our approved agency list, please complete and submit this form: ************************************* More About Us Armacell's products significantly contribute to global energy efficiency making a difference around the world every day. With more than 3,300 employees and 25 production plants in 19 countries, the company operates two main businesses, Advanced Insulation and Engineered Foams, and generated net sales of EUR 836 million and adjusted EBITDA of EUR 155 million in 2023. Armacell focuses on insulation materials for technical equipment, high-performance foams for high-tech and lightweight applications and next generation aerogel blanket technology. For more information, please visit: ***************** We look forward to receiving your application. If you want to discover more about Armacell, take another look at our website ***************** #LI-KW1 Time Type: Full time

Process Engineer We are seeking a Process Engineer to support pharmaceutical manufacturing projects in sterile fill/finish and packaging operations. This role will provide process knowledge and leadership across: Compounding / Formulation Component & Stopper Preparation (autoclaves, washers, stopper prep, etc.) Syringe Fillers Automated Inspection Autoinjector Assembly Packaging Key Responsibilities Provide process engineering expertise across fill/finish and packaging systems. Translate stakeholder and SME input into clear process requirements and operating strategies. Ensure alignment on process intent across functions and escalate issues quickly for resolution. Oversee process performance related to safety, quality, schedule, and cost. Anticipate and solve technical challenges while driving process improvements. Deliver project results on time, in full, and within budget. Qualifications Bachelor's degree in Chemical, Mechanical, or related Engineering discipline. Experience in pharmaceutical or biotech manufacturing, ideally with fill/finish or packaging exposure. Strong process knowledge in sterile operations and supporting utilities. Excellent communication, leadership, and problem-solving skills. Results-driven, hands-on approach with ability to manage multiple priorities.

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages Develops and aligns moderate complexity plans and provides mitigations, as needed Reviews piping and instrumentation diagram (P&IDs) and other process design documents Provides direction to detailed design activities in partnership with the EPCM provider Writes User Requirement Specifications (URSs) Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities Serves as on-call support for process equipment Reviews, redlines, and approves P&IDs and other technical documents as the technical authority Leads system impact assessments and quality risk assessments for process equipment Performs technology transfer (TT) activities related to process equipment Supports execution of Good Manufacturing Practices (GMP) runs Provides technical support for root cause analysis (RCA) and process deviation investigations Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures Makes decisions regarding technical risk assessments for new manufacturing equipment Provides on-floor manufacturing support for equipment issues Provides process equipment training and consultation on topics within assigned area(s) Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification Conducts training and presents information to team or other stakeholders Cross-trains on unit operations to assist team with achieving deliverables Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation Other duties, as assigned Basic Requirements Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or Master's in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience Experience in Life Science or other regulated industry Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system) Preferred Requirements • Prior experience working in a cGMP environment or other highly regulated industry • Experience working in at least one unit operation in a pharmaceutical or Life Science environment • Experience with mammalian cell culture processes WORKING CONDITIONS & PHYSICAL REQUIREMENTS Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to conduct activities using repetitive motions that include writs, hands and/or fingers' Ability to operate machinery and/or power tools Ability to conduct work that includes moving objects up to 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Salary: $ 90,000.00 We have partnered with an industrial manufacturing company in the Roxboro, NC area to provide them with a Process Engineer. Please review the below description and let us know if you are interested. Prioritized Must Have Skills for the Process Engineer: #1. Two years of post-undergraduate experience in engineering strongly preferred, with experience working on a continuous production line and/or with non-woven manufacturing. #2. Experience working with foreign and overseas business units. #3. Proven communication skills within all levels of an organization. Responsibilities of the Process Engineer: Perform job duties in compliance with site safety rules and notify appropriate management of any safety hazards, with the intent of supporting an injury-free work environment. Demonstrate leadership and commitment to the site quality management system through personal accountability, systems integration, and risk-based thinking. Abide by job related procedures, work instructions and other guidelines designed to help ensure the quality of the finished product. Be a key process facilitator and checkpoint for pre-production and production changes in a non-wovens continuous process manufacturing line. Serves as a protection against product failures, and uses influence to drive organizational and product maturity, by applying organizational management experience, team-building skills, technical and Quality systems expertise. Perform, review and approve indepth analyses of technical and business impacts of product changes. Approve subject matter expert teams for change projects, based on analysis of potential technical and enterprise impacts of the change. Review and approve design transfer strategies and compliance of product change plans, including making judgments on completeness of design and specification documents, traceability, business impacts. Direct the activities of direct and/or indirect reports to successful completion of activities listed above. Interfaces with product team members, R&D, sales, production and maintenance floor staff, and operations managers, using proven interpersonal skills Requirements of the Process Engineer: BS in Engineering or closely related discipline, or bachelors degree plus significant experience in an engineering discipline. Two years of post-undergraduate experience in engineering strongly preferred, with experience working on a continuous production line and/or with non-woven manufacturing desired. Experience working with foreign and overseas business units preferred. Proven communication skills within all levels of an organization, including proficiency in reading, writing, and speaking English. Other Key Requirements: 100% in office No sponsorship or Visa holders. No Corp-to-Corp. Benefits of the Process Engineer: Medical Insurance Dental Insurance Retirement Plan About the Company: Cyfle is a global business dedicated to connecting talents worldwide. Our comprehensive RPO services, placement services, and training services help businesses unlock their full potential.

Employment Type: Contract Business Unit: ANC Engineering & Automation Duration: 3 years with likely extensions and/or conversion to permanent Number of openings: 3 Posting Date: 06/04/2025 Pay Rate: $32 - $38/hour Notes: Standard business hours (~8 to 5) with flexibility for: Evening or weekend work, Occasional holiday support, Up to ~50 hours/week, assuming occasional OT 3 Key Consulting is hiring Process Engineers for a consulting engagement with our direct client, a leading global biopharmaceutical company. Ideal candidate is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, who has supported large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance) and are highly adaptable, collaborative, and proactive. The ideal candidate embraces ambiguity, is passionate about solving complex operational problems, and thrives in a startup-like GMP environment where they can wear multiple hats, support dynamic business needs, and help drive continuous improvement initiatives. Recruiters expected to pre-screen thoroughly and look for tangible examples of initiative and project ownership. Ideal resumes will show practical accomplishments and clearly demonstrate team-based, cross-functional efforts Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution. This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste. Top Must Have Skills: Experience working in commercial biotech manufacturing industry. Strong drive and proven results in solving complex and ambiguous problems. Demonstrated ability to work well in highly collaborative environments. Responsibilities: In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site. Responsibilities include: Serve as system owner for process equipment and systems supporting manufacturing operations. Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems. Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases. Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability. Ensure systems operate safely and in compliance with EHS standards and regulations. Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections. Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems. Monitor system performance and implement risk-reduction strategies. Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation. Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs. Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable. Lead or contribute to deviation investigations and other quality-related processes. Analyze and present findings related to operational issues and engineering projects. Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment. Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements. Maintain regular communication with leadership and team members, escalating issues with proposed solutions. Participate in a small engineering team on a project or ongoing support basis. Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed. Participate in the design and selection of systems, instrumentation, and components. Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities. Preferred Qualifications: Bachelor's degree in Chemical or Mechanical Engineering. 3+ years of relevant work experience, including 2+ years in a biopharmaceutical manufacturing environment. Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies. Proficiency with equipment and facility control systems, including troubleshooting and logic understanding. Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation). Strong communication, technical writing, and presentation skills; ability to work independently. Proven team collaboration and facilitation skills. Analytical thinking with the ability to interpret complex problems using multiple data sources. Ability to support capital projects and implement process improvements. Understanding of capital project execution from procurement through validation in GMP environments. Commitment to safety and compliance in all engineering activities. Self-starter with excellent organization, time management, and multitasking skills. Willingness to work flexible hours in support of 24/7 manufacturing operations. Why is the Position Open? Additional team member Red Flags: Gaps in employment without clear justification Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution. Not a research role. Candidates with advanced degrees seeking research roles should not be submitted. Lack of biotech experience. Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering). Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility Interview process: Manager Phone Screening followed by interview panels and post panels follow-up meeting with hiring manager. We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider * Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages * Develops and aligns moderate complexity plans and provides mitigations, as needed * Reviews piping and instrumentation diagram (P&IDs) and other process design documents * Provides direction to detailed design activities in partnership with the EPCM provider * Writes User Requirement Specifications (URSs) * Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities * Serves as on-call support for process equipment * Reviews, redlines, and approves P&IDs and other technical documents as the technical authority * Leads system impact assessments and quality risk assessments for process equipment * Performs technology transfer (TT) activities related to process equipment * Supports execution of Good Manufacturing Practices (GMP) runs * Provides technical support for root cause analysis (RCA) and process deviation investigations * Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures * Makes decisions regarding technical risk assessments for new manufacturing equipment * Provides on-floor manufacturing support for equipment issues * Provides process equipment training and consultation on topics within assigned area(s) * Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost * Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification * Conducts training and presents information to team or other stakeholders * Cross-trains on unit operations to assist team with achieving deliverables * Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation * Other duties, as assigned Basic Requirements * Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or * Master's in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience * Experience in Life Science or other regulated industry * Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system) Preferred Requirements * • Prior experience working in a cGMP environment or other highly regulated industry• Experience working in at least one unit operation in a pharmaceutical or Life Science environment• Experience with mammalian cell culture processes WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Ability to ascend or descend ladders, scaffolding, ramps, etc. * Ability to stand for prolonged periods of time * Ability to sit for prolonged periods of time * Ability to conduct activities using repetitive motions that include writs, hands and/or fingers' * Ability to operate machinery and/or power tools * Ability to conduct work that includes moving objects up to 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Insight Global is seeking a Process Engineer to join our team in Creedmoor, NC for a large automotive parts manufacturing client. The successful candidate will be responsible for enhancing the efficiency and effectiveness of our manufacturing processes, ensuring high-quality production standards, and contributing to the overall success of our engineering group. Key Responsibilities: · Directly support production areas by troubleshooting equipment or efficiency issues. · Reduce bottlenecks in the factory to improve workflow. · Design and develop parts using SolidWorks. · Manage capital purchasing of equipment to enhance production capabilities. · Conduct time studies and workflow analysis to enhance production efficiency. · Utilize Lean Manufacturing principles to drive continuous improvement initiatives. · Occasionally run Kaizen events to foster a culture of continuous improvement. · Develop and maintain documentation for manufacturing processes and procedures. · Provide technical support and training to production staff. Ensure compliance with safety regulations and company policies We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements - Bachelor's Degree o Mechanical Engineering degree, aerospace engineering degree, agriculture degree; industrial engineer degree; system engineering degree o Will NOT use: electrical engineer degree and an Engineering technology degree - 2+ years of experience in a manufacturing engineering role - Proficiency in CAD software, particularly SolidWorks - CNC machining of metals o (this means they have experience with metal cutting using CNC machines which are computer controlled machines that cut and shape metal parts - it follows a program to make the precise shape) - Experience in the automotive or heavy equipment manufacturing industry. - Certification in Lean Six Sigma or similar methodologies.

Apply now " Job Type: Long-term / Regular At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. WHAT WE ARE LOOKING FOR The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Covidien requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. This is a second shift role. YOUR ROLE * Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations. * Perform required QA inspections; i.e. Sample defect detection * Ability to participate in internal audits, as requested. * Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review. * Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing. * Assist personnel in the generation of operations/packaging area related exceptions * Have the ability to support minor exceptions and support phase II manufacturing investigations * Attend daily operations staff communication meetings * Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling * Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as, area inspections pre/post activity. * Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management. * Ability to support the QA label release functions on an as needed basis. Department Specific/ Non-Essential Functions: * Work safely in accordance with regulations, standards, and procedures and eliminate unreasonable risk to health and the environment. * Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. * Report all safety and/or environmental incidents to management immediately. * Other duties as assigned with or without accommodation YOUR BACKGROUND * BS/BA degree in Science/Business preferred * Bachelor's degree in life sciences preferred * Minimum 6 years experience in a pharmaceutical QA/Mfg environment * ASQ inspection certification. * Previous experience with statistical sampling plans. * Previous experience in investigation root cause analysis and/or writing. * Ability to work in a fast paced environment. * Ability to adjust work schedule to meet operations and customer demand. * Must be able to wear appropriate personal protective to insure safe execution of job responsibilities. Cognitive Requirements: * Skilled competency with computers, MS Office software required. * Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred WHY JOIN US We offer continued personal development. When you join Guerbet, you: * Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, * Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, * Are joining a company where we value diversity of talents coming from various horizons. Do you want to help improve patients' lives with us? We look forward to meeting you and continuing our story together! We # Innovate # Cooperate # Care #Achieve at Guerbet. Guerbet is a signatory of the Diversity Charter. We believe diversity is a source of strength, and all our positions are open to everyone. Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants. Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process. Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.