Process engineer jobs in Methuen Town, MA

Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to theglobal vaccine and therapeutic market. Responsibilities Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess' Quality System. Supervise and mentor junior engineer(s) and technicians, including a direct report Collaborate closely with cross-functional teams to support product development and manufacturing activities Qualifications BS in Mechanical Engineering, Biomedical Engineering, or a related discipline 5 - 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries; experience working on combination products is highly desirable Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus Excellent time and project management skills and proven ability to meet goals and deadlines Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams Entrepreneurial spirit and drive to positively impact global human health Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ******************.

Nationwide Opportunities Do you thrive on optimizing systems, improving yields, and driving operational excellence? Whether your background is in pharma, biotech, medical device, or advanced manufacturing, we'd love to connect. At Scientific Search, we partner with industry leaders and emerging innovators across the U.S. who rely on talented Process Engineers to enhance production efficiency, scale technologies, and ensure consistent product quality. We're continually supporting new searches and always expanding our network of process professionals. We're Interested In Connecting With Engineers Experienced In Process development, scale-up, and optimization Equipment design, installation, and validation Root cause analysis, troubleshooting, and continuous improvement (Six Sigma, Lean) cGMP manufacturing support within regulated environments Cross-functional collaboration with operations, quality, and R&D teams If you'd like to be considered for future Process Engineer roles, please send us your resume. We'll keep you in mind as new positions arise that fit your expertise, interests, and preferred locations. Submit your resume We're always growing our network of skilled Process Engineers - let's stay connected so we can help you discover the right opportunity when the time is right. #19580

The Process Engineer is responsible for analyzing, designing, and optimizing operational workflows across the organization. This role focuses heavily on documenting standard operating procedures (SOPs), building clear process maps, and driving efficiency improvements. The ideal candidate is fast, detail-oriented, and skilled at transforming complex information into simple, intuitive workflows that teams can follow. Key Responsibilities Develop, update, and optimize end-to-end process workflows using tools such as Lucidchart, Visio, or Miro. Create clear, concise, and accurate Standard Operating Procedures (SOPs), work instructions, and process documentation. Partner with operations, technology, and leadership teams to gather requirements and understand current-state processes. Identify inefficiencies or gaps and recommend improvements to streamline operations. Maintain a centralized library of process documentation that is easy for employees to understand and access. Support new system implementations by documenting workflows, mapping integrations, and validating process changes. Conduct process walkthroughs, training sessions, and knowledge-transfer workshops. Monitor process performance and track KPIs to ensure improvements deliver measurable results. Ensure that all processes comply with internal controls, quality standards, and organizational policies. Qualifications Bachelor's degree in Engineering, Operations Management, Industrial Engineering, or a related field (or equivalent experience). 2-5+ years of experience in process engineering, operations improvement, or workflow design. Strong experience with workflow design software (Lucidchart, Visio, Miro, etc.). Exceptional documentation skills and ability to convert complex processes into simple steps. Strong analytical and problem-solving abilities. Excellent communication and collaboration skills. Ability to work quickly and accurately in a fast-paced environment. Knowledge of Lean, Six Sigma, or continuous improvement methodologies is a plus. Key Traits Fast learner with an ability to quickly turn ideas into documented workflows. Highly organized and detail-driven. Comfortable working independently and managing multiple projects simultaneously. Process-minded with a passion for operational excellence.

WHO WE ARE We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Join a company where collaborative, dedicated, and talented people are the backbone of our culture. Work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Process Engineer I/II will develop and execute technology transfer plans for RoslinCT's client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. HOW YOU WILL MAKE AN IMPACT Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable. Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, as needed Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and Client program requirements Collaborate with internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions Perform test runs and development studies as needed to support client and RoslinCT initiatives Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement Be proactive in identifying opportunities to add value to processes and cross-functional teams WHAT YOU WILL BRING B.Sc. in Biological or Chemical Engineering (or similar) with 2-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics Experience with equipment support and troubleshooting Demonstrated independence in experimental design, execution, data analysis, and troubleshooting Preferred Qualifications Advanced degree or additional certifications in science, engineering, or cGMP operations Experience with bioreactor cell culture Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation Experience with Microsoft Excel and statistical programs for data analysis and visualization Excellent technical writing and oral communication skills Driven and works well independently and within cross-functional teams *May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month) OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance Security Clearance: Secret - Current At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. Our team solves tough, meaningful problems that create a safer, more secure world. Life Cycle Engineering (LCE) is responsible for ensuring our products are safe, reliable, maintainable, and delivered on time. LCE comprises multiple disciplines that support engineering, our program offices, and our customers. These disciplines are involved throughout the entire life cycle of our products-from conception to deactivation. Our primary focus is product support, which includes the following key disciplines: Reliability, System Safety, and Supportability. To help drive this mission forward, Raytheon currently has an exciting opportunity for a Principal Reliability Engineer, within our Land and Strategic Missile Defense business area. Your work will play a key role in supporting Raytheon's mission of making the world a safer place. What You Will Do Provide reliability predictions for the Patriot missile Mentor team members and provide internal training Support design reviews Lead failure analysis and root cause and corrective action studies to assure customer satisfaction Provide technical direction across various stages of missile operations, including the disposition of field return assets, complex assembly and disassembly issues, and ensuring mission readiness for flight tests. Work effectively with various engineering teams (design, manufacturing, quality, test) to conduct test data analysis and trending Communicate complex technical information to cross-functional audiences, including customers and management. Qualifications You Must Have Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 8 years of prior relevant experience. Experience with reliability predictions and/or missile scoring analysis. Qualifications We Prefer Ability to manage multiple technical projects and customer requests in a fast-paced operations environment Experience in gathering, analyzing and / or presenting data utilizing Database SQL Experience using scripts to organize data for trending analysis Experience developing and providing technical presentations to audiences including the U.S. and international customers Experience with National instruments LabView or LabWindows software packages, PXI, my DAQ, or Compact RIO hardware. Experience with system assembly, disassembly and test Experience with MS Office tools Experience with FRACAS (Failure Reporting, Analysis, and Corrective Action Systems) Proficiency in reliability modeling (e.g. Weibull analysis) Ability to conduct and oversee reliability testing (accelerated life testing, degradation testing, HALT/HASS) Expertise in various reliability methodologies (e.g. FMEA, FMECA, FTA, RCA) What We Offer Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation. This position is eligible for relocation assistance! Learn More & Apply Now! Please consider the following role type definition as you apply for this role: This is a full-time, onsite position based in Tewksbury, MA. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

Job Title: Manufacturing Engineer Pay Rate: $32.00-$55.00/hour (DOE) direct with full benefits Shift: 1st #ManufacturingEngineer #AerospaceManufacturing #MRBEngineer Job Overview: We are seeking a Manufacturing Engineer with a strong foundation in aerospace or precision manufacturing environments to provide centralized engineering support. This role is focused on mitigating overflow capacity and supporting high-priority military production programs. The ideal candidate will have hands-on experience with material disposition, MRB processes, and quality-driven manufacturing practices. This is a high-impact opportunity to contribute to the delivery of high-stress rotating components and aerospace parts. Responsibilities: * Drive Material Review Board (MRB) processes: submit, track, and clarify MRB cases, particularly related to aged Work-In-Progress (WIP). * Facilitate decision-making around WIP disposition: repair, scrap, or rework. * Track and document aged WIP across manufacturing cells. * Gather Root Cause Corrective Actions (RCCA) and collaborate with stakeholders to close quality loops. * Assist with shop floor engineering support and general process improvement initiatives. * Support general rework using machining equipment such as lathes, milling machines, and grinders. Core Qualifications: * 1+ year of experience in a manufacturing environment (aerospace preferred). * Familiarity with rotating parts, tight-tolerance machining, or high-stress aerospace components. * Knowledge of MRB procedures and ability to work with quality teams to ensure compliance and resolution. * Hands-on experience with RCCA gathering and reporting. * Experience using metrology equipment (calipers, micrometers, dial indicators, drop gauges, optical comparators, linear trace machines). * Strong communication, organizational, and self-management skills. * Due to the nature of the work US Citizenship required. Preferred Traits & Skills: * Product Release Certification (PR) or eligibility to obtain is highly preferred. * Self-directed and proactive. * Comfortable with administrative tracking and technical documentation. * Flexible and open to evolving manufacturing priorities. * Passionate about quality, learning, and continuous improvement. Belcan provides a competitive pay and benefits package. Benefits offered MAY include health, dental, vision, and life insurance; 401(k); education assistance; paid time off including PTO, holidays, and paid leave required by law. Salary guidelines for similar roles at Belcan are $32.00-40.00 per hour. Guidelines vary based on many factors including but not limited to education, qualifications, experience, discipline, geographic location, market, and business considerations. EOE/F/M/D/V Build a challenging and rewarding career with an industry leader!

WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client's business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges. Position Overview: We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. Responsibilities: This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Investigate customer complaints, from intake through investigation and closure Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes Minimum Qualifications: Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR Preferred Qualifications: Ability to multitask, handling multiple projects and changing priorities Experience in the creation and documentation of procedures and processes Must be results-driven and exhibit a sense of urgency Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written) Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Ability to act independently to determine methods and procedures Problem-solving skills and the ability to resolve issues as they arise Strong interpersonal skills, with the ability to assimilate with various cross-functional teams Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently. NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job title: Senior PSA Engineer DTS Must have skills: Bachelor's degree in electrical engineering 1.Implement, configure, and maintain GE AEMS applications for real-time and planning environments. 2.Develop and validate DTS models within GE AEMS for dynamic stability and contingency analysis. 3. Perform transient stability, voltage stability, and dynamic simulations using GE AEMS tools. 4. Integrate renewable generation and FACTS devices into DTS models. 5. Ensure adherence to NERC, FERC, and regional reliability standards. Detailed Job Description: Bachelor's degree in electrical engineering The Senior PSA Engineer DTS will lead advanced Power System Analysis PSA and Dynamic Transmission System DTS initiatives within a power utility environment. This role requires hands-on expertise in GE AEMS Advanced Energy Management System for real-time operations, stability studies, and integration of dynamic models to ensure grid reliability and compliance. Minimum years of experience: 8-10 years Education: Bachelor's degree in electrical engineering

Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts. Execute functional testing for the client's POS systems in a lab environment Validate new POS features, patches, upgrades, and configuration changes Troubleshoot issues across POS hardware, networking, integrations, and payment systems Review logs, identify root causes, and escalate defects to internal teams and vendors Collaborate with vendors delivering POS products to ensure quality and readiness Support daily version testing, weekly releases, and continuous enhancements Maintain test cases, regression suites, and documentation Ramp up on the clients POS systems, environments, and workflows Execute manual testing independently and efficiently Understand integration points with kiosk, mobile apps, loyalty, and payments Build relationships with product, engineering, and vendor teams Contribute to expanding and maintaining POS test automation frameworks Improve test coverage, defect identification, and issue resolution speed Work independently with minimal oversight while communicating affectively Support performance-related testing for high-volume transaction scenarios Help streamline testing workflows to support frequent deployments Desired Skills/Experience: 5+ years of POS Quality Engineering experience Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations Strong manual testing proficiency with the ability to execute tests quickly and accurately Ability to troubleshoot logs, hardware, and light networking issues Experience collaborating with third-party vendors on POS deliverables Familiarity with automation frameworks and ability to contribute to automation improvements Prior experience working in a POS lab environment (devices, staging stores, simulators) Strong communication, organization, and self-management skills Benefits: Medical, Dental, & Vision Insurance Plans Employee-Owned Profit Sharing (ESOP) 401K offered The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.

Job Title: Hardware/System Sustaining Engineer Details: Type: On-site Duration: Permanent Direct Hire Salary: $ Depending on Experience The Hardware Sustaining Engineer is responsible for supporting, maintaining, and improving existing hardware products throughout their lifecycle. This role bridges design engineering, component engineering, manufacturing, and quality to ensure product reliability, manufacturability, and continued compliance with standards. The role involves diagnosing hardware/system issues, instituting design updates, and designing and implementing automated product test applications. Key Responsibilities: Product Support & Maintenance Provide engineering support for released hardware products across their lifecycle. Investigate, troubleshoot, and resolve hardware failures in production, field, and customer environments. Develop and implement engineering change orders / product change notices (PCNs) to address design improvements, manufacturing improvements, and component obsolescence. Support supply chain in evaluating alternate components and managing end-of-life (EOL) parts. Manufacturing & Quality Interface Collaborate with manufacturing teams to resolve build and test issues. Support failure analysis, root cause identification, and corrective/preventive actions (CAPA). Work with design engineering and quality teams to maintain compliance with applicable safety, regulatory, and industry standards. Product Documentation Maintain and update design documentation, schematics, BOMs, and test procedures. Validate and verify design changes through lab testing and simulations. Define test plans for verification of new designs. Qualifications: Bachelor's degree in Electrical Engineering, Computer Engineering, or related field. 3-7 years of experience in hardware design, sustaining engineering, or manufacturing support. Strong knowledge of analog/digital electronics, PCB design, and system-level troubleshooting. Experience with lab equipment (oscilloscopes, logic analyzers, power analyzers, etc.). Familiarity with industry standards (UL, FCC, CE, ISO, etc.). Strong problem-solving and root-cause analysis skills. Excellent communication skills for cross-team collaboration and reporting. Preferred Skills: Experience with Python and manufacturing test scripting. Experience conducting DVT and reliability testing. Knowledge of supply chain and component lifecycle management. Hands-on experience with CAD tools (e.g., Altium, OrCAD) and PLM systems. Ability to work in fast-paced, cross-disciplinary environments. Compliance / Export Control: This position may include access to technology and/or software source code subject to U.S. export controls (including ITAR). Applicants will be required to provide information regarding citizenship/immigration status for compliance. The company may decline to proceed if authorization is required and cannot be obtained. Company Overview: Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume, salary expectations, and any references in your application .

Join a fast-paced engineering team building cutting-edge electrophysiology and connected medical technologies. As a Senior DevOps Tools Engineer, you'll design and automate the systems, workflows, and dashboards that accelerate product development and strengthen software quality across a highly regulated medical platform. You'll partner closely with engineering, QA, and technical leadership to streamline development processes, build automation that reduces friction, and enable teams to deliver reliable, compliant software at scale. What we offer you in USA We honor the contract terms you prefer. 20 paid vacation days per year 40 working hours per week Retirement Plan 401(K) Medical, Dental, Vision Insurance Plan for you and your Family 100% On-Site position in Newton What You'll Do Design, build, and maintain internal tools, scripts, and dashboards that support development, testing, and verification. Automate workflows across JIRA, Polarion, TestRail, and other platforms to boost efficiency and traceability. Create dashboards and automated reports that give teams real-time insight into quality, coverage, and development progress. Work with cross-functional stakeholders to gather requirements and deliver tailored tooling solutions. Identify gaps in existing processes and drive continuous improvement in a regulated environment. Support AWS-based development pipelines and help teams develop, validate, and deploy cloud-enabled workflows. Required Qualifications Bachelor's degree with 4+ years of software verification experience, or Master's with 2+ years. Familiarity with medical device development standards (IEC 62304, FDA guidance). Strong automation and scripting skills (Python, C++/C#, or similar). Previous experience with AWS cloud environment Experience integrating and automating tools such as JIRA, Polarion, and TestRail. Strong problem-solving abilities and attention to detail. Solid understanding of documentation best practices. Preferred Qualifications Experience with Git and modern version control workflows. Knowledge of HTML, Flask, Nginx, or related web technologies. Experience working in Agile development environments. Strong communication skills and the ability to collaborate in fast-paced teams. Self-starter with entrepreneurial drive and ownership mentality.

🚀 Contract Opportunity - Quality Engineer (Edifecs Project) 📍 Remote (U.S.-based only) | 💼 7-Month Contract | 💰 W2 Only We're looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team. Key Responsibilities Review business requirements and data mappings related to the HealthRules Payor ecosystem. Perform manual testing, create and execute test cases, and document results. Design or contribute to comprehensive testing plans. Conduct SQL-based validation and data analysis. Collaborate with technical and business teams to ensure data accuracy and functional integrity. (Optional) Contribute to testing automation or agentic testing initiatives. Required Skills & Experience Strong background in U.S. Healthcare systems and processes. Hands-on experience with HealthRules Payor and HealthRules Data Warehouse. Proficiency in SQL for validation and data testing. Demonstrated experience creating and executing manual test cases. Excellent attention to detail, documentation, and communication skills. Must be authorized to work in the U.S. (W2 only) and reside within the United States. Nice to Have Familiarity with Edifecs integration and testing frameworks. Exposure to automation or agentic testing tools. 📩 Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.

Cost Manufacturing Engineer - PERM role US Citizen Education & Experience Bachelor's degree in manufacturing, Mechanical, Industrial Engineering, or related discipline (or equivalent experience). 5-7 years of related experience in cost engineering, estimating, or manufacturing operations. Knowledge of metal stamping, heat treating, plating, welding, mechanical assembly, and CNC machining preferred. Proficiency in ERP systems (Syteline or similar), Microsoft Excel, SolidWorks, Outlook, and MS Project. Job Duties Utilize cost methodologies and tools to prepare and maintain reliable and accurate cost data. Identify and quantify potential cost uncertainties to ensure costing models capture the full range of risks. Establish cost estimates for production processes and tooling; review alternatives and recommend improvements. Track actual costs against estimates and report regularly to ensure alignment with forecasts. Investigate and identify cost reduction opportunities through detailed cost analysis. Contribute to cost monitoring and reporting systems; analyze cost trends and variances. Review monthly manufacturing variance reports to analyze deviations and adjust costs as needed. Coordinate with project management, engineering, procurement, and other stakeholders to ensure cost objectives are met. Analyze technical documents, blueprints, and vendor quotations to develop detailed cost estimates

About the Company Critical Process Filtration, a TCPA Company, a leading manufacturer of high-quality filtration solutions for pharmaceutical, electronics, process water, and gas filtration is looking for a Applications Filtration Engineer. About the Role The Applications Filtration Engineer will support the development, evaluation, and optimization of filtration technologies across a broad range of bioprocessing and industrial applications. This role plays a key part in shaping next-generation products through experimental research, customer application analysis, and cross-functional collaboration. The Applications Filtration Engineer will be responsible for designing studies, generating performance data, supporting product development, and ensuring our filtration solutions meet both technical and customer-driven requirements. This role offers the opportunity to contribute directly to innovative filtration solutions that serve high-growth global markets. Responsibilities Technology & Application Development Support the development and characterization of filtration technologies including normal flow filtration, tangential flow filtration, and solid/liquid separation systems. Design and execute laboratory experiments to assess filter performance, validate test methods, and evaluate new materials and device configurations. Analyze performance data and use statistical tools to develop insights, optimize designs, and provide recommendations for product improvements. Translate customer application needs into engineering requirements to guide internal R&D efforts. Customer & Market Support Partner with sales, marketing, and product management to provide technical expertise for key customer applications. Assist in field evaluations, prototype testing, and troubleshooting to ensure optimal performance in customer processes. Support the preparation of technical documentation, application notes, presentations, and training materials. Cross-Functional Collaboration Work closely with manufacturing, quality, regulatory, and engineering teams to ensure product readiness and alignment with customer expectations. Participate in product development reviews and provide data-driven input on design, performance, and application requirements. Engage with internal stakeholders to drive continuous improvement in test methods, product understanding, and application knowledge. Innovation & Research Identify emerging filtration technologies, materials, and methods that can enhance performance or open new market opportunities. Contribute to intellectual property development, internal reports, and industry conference presentations. Qualifications Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Mechanical Engineering, or another STEM discipline. Relevant experience in biotechnology, bioprocessing, filtration, or related laboratory research. Strong understanding of filtration principles, membrane technologies, or downstream bioprocessing. Experience designing and conducting laboratory experiments and developing test methods. Proficiency with statistical analysis, DOE, and data processing tools (e.g., Minitab, Excel, Python, MATLAB). Familiarity with data acquisition systems, sensors, and laboratory instrumentation. Knowledge of computational modeling or fluid dynamics (e.g., COMSOL) is a plus. Effective communication skills with the ability to present technical information to multiple audiences. Demonstrated problem-solving ability and a track record of technical accomplishments. Equal Opportunity Statement Critical Process Filtration is proud to be an equal opportunity employer. EEO Statement: We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************

Job Title: Senior Manufacturing Engineer Job Type: Full Time, On Site Pay Range: $100,000 to $145,000 Benefits: Health, Dental, 401K, generous PTO and more Adecco Permanent Recruitment is partnering with a well-established manufacturer in the specialty components and life sciences space to help them hire a Senior Manufacturing Engineer. This role joins a rapidly growing team that is expanding production capacity and optimizing extrusion and cleanroom operations. The engineer will support process development, equipment integration, and continuous improvement efforts that enable high quality output and future scaling of production. Key Responsibilities Lead development, optimization, and standardization of extrusion and cleanroom manufacturing processes. Collaborate with global engineering teams to transfer processes, equipment specs, and best practices. Support capital planning, including equipment justification, procurement, and implementation. Drive process controls that reduce scrap, rework, and variability while improving throughput and quality. Lead or participate in safety, ergonomic, and Lean initiatives that enhance workflow and compliance. Provide hands-on troubleshooting, diagnostics, and support for extrusion and assembly equipment. Maintain accurate production routing and manufacturing data within the ERP system. Support training efforts for production teams on new or updated equipment and processes. Qualifications and Must-Haves 5 to 10 years of manufacturing engineering experience with strong, hands-on exposure to extrusion. Cleanroom or highly regulated manufacturing experience, ideally with Class 7 environments. Proficiency with SPC, Lean tools, DFMA, FMEA, RCA, and continuous improvement methodologies. Experience analyzing, modifying, and optimizing extrusion and test equipment. CAD proficiency in 2D and 3D environments. Six Sigma Green or Black Belt preferred. Strong problem solving ability and comfortable working in a collaborative, team-oriented environment. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ********************************************** The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Salary range: $87,100K P/A- $120,000 K P/A Are you a Software Installation Engineer looking for a great new opportunity? Our Natick, MA client is looking to hire a Software Installation Engineer to package, deploy, maintain, and troubleshoot a variety of enterprise applications with a strong eye towards security. This will rely heavily on automation to ensure reliable and efficient delivery. This will involve everything from creation through to retirement, including updates, version control, delivery portal integration, and much more! This is a full-time, direct hire role. Don't miss a great chance to join a large, stable, and growing company with a great work environment! Must haves: 3+ years enterprise Network Engineer experience Bachelors degree InfoSec knowledge InTune (or similar) Work with cross functional teams HM Notes: App packaging Security focused is needed - someone that has worked closely with infosec - not active patching - automation requests to bundle / configure / test / patching InTune is one of the bigger tools PatchmyPC is being used - but not widespread Windows Adding bandwidth? There are current fulltime people doing this - they're overloaded Client JD: The Software Installation Engineer is responsible for overseeing the packaging, deployment, maintenance, and troubleshooting of applications across the enterprise environment. This role ensures efficient and reliable delivery of approved software through automation tools and deployment systems, enabling a seamless experience for end users. Responsibilities Application Packaging & Deployment Manage the full lifecycle of application packaging, from creation to deployment and retirement. Ensure accurate version control, timely updates, and smooth integration with end-user delivery portals (e.g., Company Portal). Maintain high standards of reliability and usability to support business workflows. Tooling Administration Administer and maintain application deployment and packaging tools that interface with user-facing systems. Diagnose and resolve application packaging, deployment, and automation issues. Collaborate with vendors and internal teams to implement fixes and enhancements. Collaboration & Coordination Partner with application requestors, Asset Management, and Legal teams to ensure compliance with software approval and licensing processes. Work closely with cross-functional stakeholders to align deployment solutions with organizational standards and timelines. Compliance & Security Serve as the point of contact for Information Security to evaluate and block vulnerable or compromised applications. Ensure compliance with internal policies and external security requirements. Monitoring & Reporting Track deployment performance, analyze data trends, and maintain portal reliability and responsiveness. Minimum Qualifications A bachelor's degree and 3 years of professional work experience (or a master's degree, or equivalent experience) is required. Candidates for this position must be authorized to work in the United States on a full-time basis for any employer without restriction. Visa sponsorship will not be provided for this position. Additional Qualifications Proficiency in application packaging and deployment, particularly with automation tools or scripting (e.g., PowerShell, PatchMyPC, WinGet). Strong understanding of Windows operating systems, drivers, and enterprise deployment practices in a hybrid environment (cloud and on-prem). Hands-on experience with management tools such as Intune, EntraID, AutoPilot, Active Directory and Group Policy. Proven customer service experience with the ability to translate customer requirements into practical technical solutions. Excellent analytical, problem-solving, and troubleshooting skills. Strong written and verbal communication skills. Familiarity with the mac OS platform is a plus. Experience in enterprise environments.

General information Location Burlington, MA Ref # 43424 Job Family Research Workplace On-Site Date published 12/12/2025 Time Type Full time Pay Range 58000 - 76,667 Usd Annual Description & Requirements Clinical Laboratory Process Development Associate (PDA) The Genomics Platform has delivered on transformative projects for more than 30 years. We create foundational genomics resources and capabilities for the community and undertake large-scale disease-based projects that pioneer approaches and advance the understanding of the genomic basis of disease and other traits. We are dedicated to solving the world's most challenging biomedical problems through the continuous development and investment in cutting edge technology and large-scale research projects that are both challenging and complex. Data generated by the Genomics Platform has enabled a wide range of applications, from variant discovery to delivery of polygenic risk scores and clinical diagnoses, and contributed knowledge to a wide array of fields, from rare disease research to population genomics, from cancer clinical trials to understanding cell circuitry. We are expanding our team to support constantly evolving initiatives at our new, state-of-the-art facility located at 27 Blue Sky Drive in Burlington, MA. The Clinical Laboratory Process Development Associate (PDA) will be committed to carrying out innovative, high-throughput lab processes and supporting the highest quality research to realize the full promise of genomic medicine. Process Development Associates I (PDA I) are responsible for processing samples through a high throughput clinical diagnostics laboratory and to meet production goals. PDAs will function as the regulatory equivalent of clinical laboratory technical personnel (i.e. medical technologists). PDAs will be trained to perform clinical laboratory tests under general supervision. In addition to standard production processes, this position will require individuals to participate in continuous improvement solutions through appropriate change management procedures and troubleshooting processes as needed. The individual may be involved with the designing and executing of development, process improvement, or troubleshooting projects under direct guidance from the supervisor in support of platform goals and may be required to complete related training in JMP, Six Sigma, or other process improvement methods. Upon completion of these projects the individual is responsible for documenting and communicating results to others in the Platform during dedicated meetings. In addition, PDAs will assist with the general supervision of work of other laboratory personnel such as Process Development Technicians and Accessioning Technicians as required. Primary Responsibilities: Follow standard operating procedures Each individual performs only those high complexity tests that are authorized by the Laboratory Director and require a degree of skill commensurate with the individual's education, training, experience, and technical abilities. Tests will require the exercise of independent judgment and responsibility with minimal supervisor by the laboratory director or supervisor Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance. Be capable of identifying problems that may adversely affect test performance or reporting of test results. Correct the problems according to procedures or immediately notify the General Supervisor, Technical Supervisor, Clinical Consultant or Laboratory Director. Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications. Review and monitor quality metrics and communicate results to others in the Platform during dedicated meetings as needed. Minimum Qualifications: BS/BA degree in Biology or Chemistry. Please be prepared to provide a copy of the diploma and transcripts upon request. 1+ years of relevant full time clinical laboratory experience in this specialty subsequent to obtaining B.S./B.A. degree Working, solid knowledge of primary biological science principles required. Recent (within the last year) laboratory experience with the use of standard lab equipment such as pipettes and centrifuges required Strong analytical skills, problem solving ability, and innovation aptitude required. Working knowledge of computers, databases, and working in a Windows/Mac environment required. Required Skills and Attributes: Must have strong attention to detail, the ability to multi-task and strong organizational skills. Must follow Standard Operating Procedures and policies. Excellent written and oral communication skills, interpersonal skills and ability to effectively work as part of a team required. Ability to work independently with minimal supervision. Must thrive in a fast-paced environment. Preferred Experience: Experience with RNA and/or DNA extraction and library construction Experience with genomic sequencing Experience with laboratory automation Data accessioning experience The expected base pay range for this position as listed above is based on a 40 hour per week schedule. Broad provides pay ranges representing its reasonable and good faith estimate of what the organization reasonably expects to pay for a position at the time of posting. Actual compensation will vary based on factors including but not limited to, relevant skills, experience, education, qualifications, and other factors permissible by law. At Broad, your base pay is just one part of a comprehensive total rewards package. From day one, this role offers a competitive benefits package including medical, dental, vision, life, and disability insurance; a 401(k) retirement plan; flexible spending and health savings accounts; at least 13 paid holidays; winter closure; paid time off; parental and family care leave; and an employee assistance program, among other Broad benefits. The Broad Institute is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. Should you need a reasonable accommodation to complete the application or interview process, please contact ***************************** for assistance.

Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics. The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. Key Duties and Responsibilities: * Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities. * Evaluate, select and manage external capabilities for cell line development. * Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies. * Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation. * Develop and manage project timelines and budget for CLD activites. * Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals. * Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer. * Review and approve technical protocols, development reports, and data packages provided by CDMOs. * Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners. * Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD. * Serve as a subject matter expert in regulatory agency interactions, audits, and inspections. * Expected travel: 10-20% (domestic and international) Required Education: * PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience. * Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered. Required Experience and Skills: * Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins. * Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred. * Knowledge of upstream process development and analytical methods related to CLD. * Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows. * Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.). * Proven track record of delivering on complex biologics development programs. * Excellent interpersonal, communication, and organizational skills. * Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment. #LI-LE1 Pay Range: $166,800 - $250,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com