Process Engineers
Process engineer job in Boston, MA
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
Process Engineer III
Process engineer job in Woburn, 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 ******************.
Process Engineer
Process engineer job in Hopkinton, MA
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.
Manufacturing Engineer I (Andover, MA)
Process engineer job in Andover, MA
JOIN AN INDUSTRY LEADER! Quality First & Green Always.
Sloan is the world's leading manufacturer of commercial plumbing systems and has been in operation since 1906. We are at the forefront of the green building movement and provide sustainable restroom solutions. We manufacture water- efficient products including flush valves, electronic faucets, soap dispensing and sink systems along with vitreous china fixtures for commercial, industrial and institutional markets worldwide.
We are seeking a Manufacturing Engineer I based out of our Andover, MA location that will report to the Manufacturing Engineer Manager. The Manufacturing Engineer I will plan and design our manufacturing processes. This role will also be responsible for maximizing the overall efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. They will also determine parts and tools needed in order to achieve manufacturing goals according to product specification.
What you'll do:
Developing, controlling and maintaining the manufacturing production process including controlling the design and procuring of fixtures, tooling, capital equipment.
General production floor support including maintain production floor equipment.
Responsible for continuous process improvement tracked by quality yields and standard labor costs.
Creating and maintaining visual aides, maintenance records, procedures and other documents.
Preform time studies on new and existing product line.
Training supervisors group leaders and operators in any new processes or products.
Organizing production floor builds for engineering/prototypes.
Other duties and responsibilities as required.
What we're looking for:
Bachelor's Degree in Engineering or Science
1+ Years Relevant Experience
Ability to trouble shoot problems with production process parts, and equipment, Fixture Design, Word, Excel, CAD System, Versatile. Strong oral and written communication systems.
Ability to apply mathematical concepts to practical situations.
A plus, but not required:
SAP, Lean, Six Sigma background knowledge.
Why you'll love working here:
Inclusive Culture: YOU Belong at Sloan. At Sloan, we are committed to fostering an inclusive and diverse workplace where diverse backgrounds and perspectives are embraced and celebrated. We proudly offer equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity and expression, national origin, disability, age, genetic information, marital status, political affiliation, veteran status, or any other characteristic protected by law.
Growth Opportunities: We invest in our employees' professional development with ongoing training and career advancement opportunities.
Innovative Projects: Be part of exciting projects that push the boundaries of technology and have make a real difference in the world.
Compensation:
The compensation range for this U.S.-based position is $
85,552 - $95,058
annually.
Our compensation range reflects our good faith estimate of what an ideal candidate can expect, but final agreed upon compensation will always be based on the individual candidate's experience, skills, qualifications, and other job-related or market factors that may prove relevant during the hiring process.
Benefits:
Comprehensive Health Coverage: Medical (including prescription coverage), Dental, and Vision Insurance, effective the first of the month following your hire date.
Health Savings Account (HSA): With company contributions for most medical plan options.
Financial Security: Basic Life, Basic Accidental Death and Dismemberment, Short-term Disability, Long-term Disability, and Accident Insurance.
Additional Protection: Optional Life, Critical Illness, Hospital Indemnity, Legal, Pet Insurance, and Identity Theft Protection.
Convenient Commuter Benefits: Save on your daily commute.
Flexible Spending Accounts: Dependent Care FSA to help manage your expenses.
Wellness Support: Employee Assistance Plan and Wellness Programs to keep you healthy and happy.
Retirement Savings: 401(k) Retirement Savings Plan with a company match and immediate vesting.
Generous Time Off: Paid Holidays, Volunteer Time Off, Paid Time Off, Sick Leave, Military Leave, Parental Leave, Bereavement Leave, and other paid or unpaid state/local leaves where required.
Work-Life Balance: Hybrid Work Program to support your flexibility.
Employee Referral Program: Earn rewards for referring great talent.
Professional Development: Tuition Reimbursement Program to help you grow your skills.
Community and Networking: Join our Employee Business Groups and connect with colleagues.
We Are Proud Partners With The Chicago Cubs
We are a Legacy Partner of the Chicago Cubs and we are proud to be the organization's official water efficiency partner! Through this relationship, which includes the naming rights to Sloan Park, the Cubs' Spring Training facility in Mesa, Arizona, we have had the opportunity to promote our brand and continue our water conservation efforts in the city of Chicago and around the world.
JOIN AN INDUSTRY LEADER!
For additional company information please visit our website at *************
We Are An Equal Opportunity Employer.
Senior Process Engineer Technical Services
Process engineer job in Everett, MA
& Responsibilities
The Senior Process Engineer Technical Services is responsible for driving overall process technology implementation initiatives, continuous improvement / optimization programs, and leading innovation as it relates to Radius shredders, joint products, and other ferrous and non-ferrous operations. Improving yields, product quality and developing new product streams is a key pillar of the technical services department strategy and as such, this role is a key role in ensuring Radius' success in delivering on improved production metrics, throughput, product quality, sustainable low carbon products and reducing environmental footprint.
Essential Functions
Play a key role in implementing the metal recovery technology strategy and other technological improvements across the Radius enterprise.
Project manage the overall execution of technology, continuous improvement and capital projects, ensuring proper resources are identified and assigned, projects are scoped and scheduled, and progress is monitored and managed.
Lead process improvement and technological advancements in recycling with the goals of enhancing product quality, increasing metal recovery (reduce/divert landfill), help in creating new product streams (plastics, tires, and other adjacencies), and growing process efficiencies (throughput, mechanical availability, etc.).
Establish and maintain necessary relationships and contracts with third party service providers, engineering firms, contractors, and consultants to ensure initiatives are appropriately engineered and adequately resourced.
Act as a technical resource to the management teams (shredder, JP, maintenance, etc.) to assist with any technical opportunities that arise during operations.
Leverage existing systems as well as define and establish new improved systems and processes.
Ensure project budgets are effectively and efficiently utilized and met.
Develop and deliver training and support tools for operations to institutionalize new technologies and process improvements.
Assist in the development of fiscal year capital plans for any of the continuous improvement or reliability projects, including but not limited to, major maintenance projects, outages and others.
Provides process training to employees as necessary.
Work closely with Environmental, Health & Safety teams to ensure adherence to all Radius policies and procedures as well as identify opportunities for sustainability improvements and reducing impact on the environment.
Ensuring a safe work environment for all employees, customers and visitors.
Internal Control Responsibilities
Supports Internal Control process which includes understanding, communicating, and complying with defined internal controls as well as suggesting and making modifications to the policies, procedures, and controls to better match the business.
Communicates upward problems in operations, noncompliance with the code of conduct, or other policy violations or illegal actions.
Interpersonal Contacts
The Senior Process Engineer - Technical Services will be required to develop and maintain effective working relationships with Technical Services peers, the Operations team including Operations Managers (Shredder, Shear, Balers and Joint Products), Regional Managers, Purchasing Managers, Maintenance Managers at Radius facilities.
The role will also be required to develop and maintain effective relationships with preferred service providers, equipment suppliers and contractors.
Job Conditions
This position will require frequent travel, up to 60% of the time. Visits to yards in each region can be expected to be under all weather conditions. Physical hazards may be present due to the equipment and machinery used throughout the recycling facility and the presence of the scrap itself. This position may require work beyond normally scheduled hours at times to support operations.
Qualifications
Bachelor's degree in an Engineering Field and 5 years of process engineering and project management experience; or equivalent combination of education, job experience and knowledge.
Previous experience in the scrap metals recycling industry or an adjacent heavy industry (e.g., mining, gas & oil, municipal waste recycling, heavy fabrication & processing) is desirable.
Experience leading and implementing continuous improvement / optimization projects.
In addition, a keen drive for safety at work and understanding of environmental permitting processes.
This position requires possession of a valid driver's license and the ability to drive an automobile.
Ideal Competencies
Ability to apply logical principles to solve practical problems and deal with many variables and determine a specific course of action.
Ability to analyze data, to develop effective strategies from such analysis, and to translate these strategies into effective actions at the operational level.
Accountability
Integrity
Customer Focus
Use of functional expertise
Teamwork
Physical Requirements And Work Environment
Able to: travel domestically and internationally, sit, stand, or walk for up to 6-8 hours per day; bend, crouch; climb, balance, push/pull, lift or carry up to 50 pounds. Able to write by hand and keyboard for extended periods of time. Communication is primarily by phone, email and in person, with other departments within the Radius Group. Visual acuity is needed for close detail work, preparing and analyzing data figures, accounting, and computer use.
Engineer III - NPI Manufacturing
Process engineer job in Andover, MA
Title: Engineer III - NPI Manufacturing
Duration: 6 months+ (possible extension)
Shift: Monday-Friday (8:00 am- 5pm)
Responsibilities:
Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
Must haves:
Bachelors Degree at a Minimum
Only Candidates with a Medical Device Background
5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
Test Method Validation and Verification (TMV, V&V)
Senior DevOps Tools Engineer
Process engineer job in Newton, MA
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.
Manufacturing Engineer
Process engineer job in Ayer, MA
Essential Functions:
Evaluates manufacturing processes by conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, and materials, conferring with suppliers, and soliciting observations from operators/production technicians.
Performs problem solving and root cause analysis of manufacturing issues. Recommends and implements effective corrective actions.
Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; and conferring with equipment suppliers. Prepares written and graphical work instructions for the communication of manufacturing requirements to production personnel.
Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout. Assures process control and reliability for assigned area(s).
Assures product and process quality by designing testing and inspection methods, testing finished product and process capabilities, and establishing standards to confirm and validate manufacturing process requirements.
Qualifications:
Bachelor's degree (BS) in Manufacturing Engineering or related engineering field.
Professional entry level position.
May have limited prior industry experience or worked with direction in student internship programs. Society of Manufacturing Engineering (SME) or Mechanical Engineering (ASME) certification desired.
Fundamental knowledge of metallurgy and heat treatment of common aerospace materials.
Fundamental knowledge of lean manufacturing/production principles and techniques.
General knowledge of aerospace industry or similar industry products and legal and regulatory requirements related to manufacturing plants. Ability to use standard business applications software and/or specialized data analysis tools.
May be required to develop skills in drafting, programming, and CAD or other computer aided manufacturing systems.
Ability to research and analyze data and develop recommendations or resolve problems.
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
POS Quality Engineer
Process engineer job in Canton, MA
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.
Quality Systems Engineer (Medical Devices Industry) @ Andover, MA
Process engineer job in Andover, MA
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.
Hardware/System Sustaining Engineer
Process engineer job in Milford, MA
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
.
Quality Engineer
Process engineer job in Billerica, MA
The Manufacturing Quality Engineer will be highly involved in the manufacturing aspects of the business, with an emphasis on Quality. The Quality Engineer will handle multiple projects and tasks throughout product development, product launch, and manufacturing. Additionally, this individual will ensure that product meets quality standards consistent with customer and other regulatory requirements. This role also supports plant activities in customer issues, supplier issues, and initiate corrective actions with an emphasis on process improvement. The mission of the Manufacturing Quality Engineer is to enhance the quality of materials and products through detection, analysis, and correction of conditions leading to nonconformance.
Job Functions:
Support, maintain, and sustain QMS.
Audit processes and products.
Complete first piece inspection activities.
Support incoming inspection and communicate with suppliers regarding SCARS and other issues.
Confer with engineers about the quality assurance of new products and development of procedures and quality requirements.
Develop and update PFMEAs and Control Plans, as necessary.
Assist in resolving customer quality issues.
Investigate nonconformance reports and coordinate corrective / preventive actions.
Perform internal audits and mentor process owners toward improvement.
Participate on improvement teams for safety, quality, or cost.
Collect and analyze internal/external quality data and report.
Perform other duties as assigned to support the advancement of quality systems and operations.
Skills:
Good team player.
Good problem-solving skills.
Effective communication skills.
Strong computer skills and knowledge of MS Office Suite.
Working knowledge of print and specification interpretation.
Required Experience:
BS in Mechanical Engineering, or another technical field.
2+ year experience in Quality or Manufacturing background in diecast or injection molded products.
Hands on experience measuring with various gauges and tools.
Experience in 5S, lean or other continuous improvement methods.
PPAP, QMS, NADCAP, and ISO9001 standards experience
Quality Engineer
Process engineer job in Portsmouth, NH
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 ************************
Robotics Engineer - Software and Integrations
Process engineer job in Plymouth, MA
Greensea IQ is a world leader in advanced robotic solutions for the ocean. We area dual- use technology company that has pioneered the use of autonomous systems in critical defense applications and is now transitioning that mature technology to the commercial maritime markets.
Greensea has a defense product portfolio focused in Mine Countermeasures, Explosive Ordnance Disposal, and Special Operations. Since2017, we have pioneered the use of autonomous robots and artificial intelligence to create scale and safety in ocean warfare while protecting the warfighter.
Greensea's emerging Ever Clean product transitions defense technology to the commercial sector to create high impact and achieve significant growth within a large market. EverClean uses autonomous underwater robots to keep the hulls of ships clean, allowing ships to perform optimally. This Robot-As-A-Service business provides significant fuel savings, carbon missions reductions, and increased vessel performance through a simple subscription program.
Job Description
The Robotics Engineer - Software & Integrations will be a critical member of Greensea IQ's multidisciplinary engineering team, with primary responsibility for the Bayonet Family of Products at our Plymouth, MA facility. This role focuses on developing, maintaining, and integrating software into the Bayonet AUGV line of vehicles, RNAV family of systems, HANC Subsea Control System, and IQNS, ensuring production-ready deployment and robust system performance.
The engineer will lead the integration and testing of navigation, control, and embedded software systems on Bayonet products. They will collaborate closely with production technicians, software teams, and product managers, spending significant time in the field running and validating Bayonet systems.
Responsibilities
Serve as the principal stakeholder for the integration of software on the Bayonet line of products in Plymouth, MA location
Participate as a multidisciplinary engineering team member.
Work closely with other software stakeholders, including the software Product Manager and software development team for Greensea's defense software products, to land software successfully and reliably on the Bayonet production systems.
Support production technicians in the production and commissioning of Bayonet Family systems.
Design, analyze, develop, test, and integrate control and navigation software systems for unmanned vehicles and products.
Develop, test, and integrate device interface software drivers.
Support hardware integrations as a software application for robot systems.
Support robot testing as a software stakeholder.
Innovate to discover solutions that enhance the relationship between marine vehicles and the operators that use them.
Support clients and operators as they apply Greensea IQ's technology to the work they do in the field.
Produce clear, reliable, and reusable code.
Maintain clear documentation.
Actively and passionately participate in field testing.
All other responsibilities as reasonably assigned.
Requirements
Bachelor's degree in Math, Physics, Computer Science, or a related field.
3-5 years of relevant experience.
Proficiency in C++ or comparable object-oriented programming language.
Working knowledge of mobile or underwater robot systems, including their sensors, construction, and use.
Experience with hardware interfaces, embedded systems, edge processing, and distributed computing.
Strong working knowledge of the Linux operating system, embedded systems, and embedded Linux.
Strong written and oral communication skills.
To apply, please send your resume, salary requirements, and cover letter to careers@greensea IQ.com as PDF documents. The candidate must be eligible to work in the United States. This role may require occasional travel. This position is based in Plymouth, MA. Annual salary range: $115 - 130k.
Greensea IQ (************ IQ.com) is an equal opportunity employer. We offer a casual and fun work environment and provide our employees training and continuing education opportunities. GreenseaIQ offers competitive salaries and a complete benefits package, including full health insurance, 401(k), and paid vacation, holiday, and sick leave.
FM Approvals Research Campus Engineering Technician - Materials
Process engineer job in Glocester, RI
FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.
The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.
Perform assigned tests, investigations or experiments. This may require minor modifications in test setups or procedures as well as subjective judgments in measurement.
Selects, sets up, and operates standard test equipment and records technically sound test data within budgetary and time constraints. Fabricate and construct necessary testing apparatus from existing components. Set-up and tear-down operations for routine investigations and tests.
Trouble-shoot all problems and take corrective actions. Use specialized equipment and apparatus to collect data, calculate or record results, prepare reports and/or technical data. Prepare and present clear and concise data in a prescribed format.
Provide requested advice in areas of specialization to superiors and peers and technical directions to subordinates. Increase your knowledge of testing procedures and related technological advances so as to contribute to personal development and the achievement of personal and unit goals and objectives. Keep the supervisor informed of the status and progress of all work in process and of any significant developments affecting assigned projects.
Education: High School / Trade School or Military specialist experience
Experience (Eng Tech): 3 years general construction and 1 year laboratory experience ideal
Skills/Knowledge: Laboratory testing, product assembly, equipment repair, mathematical computation or data tabulation, use of laboratory test equipment and computer literacy.
Good mechanical skills with familiarity of common hand tools and power tools, ability to work independently.
Must be able to work while wearing full Firefighter's Turnout gear with SCBA for an extended period of time in a wet and smoky environment
Must be able to obtain certification for using a personal respirator and work while wearing one for an extended period of time in a wet and smoky environment
Excellent communication and customer service skills (both orally and in writing) and the ability to work effectively as a member of a team are required.
Ability to read, write and speak English proficiently.
Ability to understand and follow English instructions
Ability to push, pull, lift and carry up to 50 pounds (unassisted) on a regular basis; up to 75 pounds occasionally.
Ability to safely and efficiently operate power equipment such as: cranes, fork lifts and other material handling devices, use ladders, operate tools such as, but not limited to, table saws, portable saws, hammer drills, screw guns and impact wrenches and be certifiable for the use of a respirator.
Candidate must possess good balance to regularly step on and off equipment and work from ladders and platforms to perform various tasks.
The final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.
#LI-TA1
Auto-ApplyDevice Engineer (PhD)
Process engineer job in Wilmington, MA
Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and remote healthcare.
ADI fosters a culture that focuses on employees through beneficial programs, aligned goals, continuous learning opportunities, and practices that create a more sustainable future.
About Analog Devices
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at ************** and on LinkedIn and Twitter (X).
Job Description
The candidate will be part of a multifunctional group that defines, develops and delivers innovative device and process solutions to enable and enhance technology platforms needed for ADI's long term scale and success in power products. The person should have a deep understanding of semiconductor devices and silicon processing technology.
Responsibilities and Duties include but not limited to:
* Design semiconductor devices and define process DOE splits in the fab
* Setup test measurements in lab and collect automated data as needed
* Define optimum process and device layouts
* Support technology qualification and implementation for new products
* Support production ramp up of new technologies and products
Minimum Qualifications:
* Advanced degree in electrical engineering, material science or similar discipline
* Expertise in lab measurement and data analysis tools
* Strong analytical mind, problem solving skills, good communicator and team player
For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.
Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
EEO is the Law: Notice of Applicant Rights Under the Law.
Job Req Type: Graduate Job
Required Travel: Yes, 10% of the time
The expected wage range for a new hire into this position is $108,800 to $149,600.
* Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
* This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
* This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
Auto-ApplyProcess Development Associate Director - Cambridge, MA
Process engineer job in Cambridge, MA
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Associate Director
What you will do
Let's do this! Let's change the world!
In this vital role you will manage an integrated group of cell culture and purification scientists working together to advance Amgen's rich, exciting and dynamic pipeline.
Located at our Cambridge Massachusetts site, this scientific leadership position will be responsible for the development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs.
The Pivotal Biologics Drug Substance Process Development organization supports the commercialization of the drug substance manufacturing processes for all late-stage programs across the Amgen portfolio, enabling advancement of programs from Ph II/III clinical trials to marketing application and commercial launch.
Lead a group to apply platform approaches and use solid problem-solving skills to rapidly solve development challenges and build robust processes with efficient experimentation. With Amgen's biology first approach, the position provides the unique opportunity of being able to work on a wide range of biologics molecules including antibodies, biosimilars, bispecifics, and other novel protein-based modalities.
Develop and recruit strong and diverse teams and support staff in their career development.
Leadership of matrix cross-functional teams that deliver robust drug substance commercialization data packages (including authoring of CMC sections of regulatory documents, interaction with regulatory agencies, support of technology transfers and working with various contract development and manufacturing organizations).
Ideation, development, and deployment of differentiating technologies and establishing a culture of innovation.
Expand Amgen's external eminence as well as representing Amgen in the external scientific community.
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.
Basic Qualifications:
Bachelor's degree and 9 years of Scientific experience OR
Master's degree and 7 years of Scientific experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 4 years of Scientific experience
Preferred Qualifications:
Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences with 4+ years of experience. Bachelor's or Master's degree with 10+ years of relevant industry experience would also be considered.
Proven track record problem solving and troubleshooting in a process development environment. Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems.
Experience with drug substance commercialization activities, including interactions with regulatory agencies. Familiarity with design of experiments and statistical analysis of data.
Strong expertise in bioprocess development including cell culture, harvest, and purification.
Track record of innovation. Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications and conference presentations.
Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication and scientific writing skills.
Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives in defined timelines.
Demonstrated success working with diverse team members in a dynamic, cross-functional environment.
Proven track record of mentoring and helping staff members reach their potential.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range
175,502.00 USD - 200,912.00 USD
Process Development Sr. Associate - Drug Product Technology
Process engineer job in Cambridge, MA
Career CategoryOperationsJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Process Development Sr. Associate - Drug Product Technology
What you will do
Let's do this. Let's change the world. In this vital role you will join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team and support the characterization and development of small molecule drug candidates. This role is primarily laboratory-based and focuses on understanding physicochemical and biopharmaceutical properties that impact formulation design, stability, and oral bioavailability. The candidate will work closely with scientists on molecule assessment, solid-state characterization, and analytical teams to support early development programs.
Key Responsibilities include:
Conduct physicochemical profiling of small molecule drug candidates (e.g., solubility, pKa, logP/logD, hygroscopicity, dissolution, and chemical stability).
Assess developability risks by integrating experimental data on molecular properties.
Support material characterization to guide form selection and formulation strategy.
Perform solid-state analysis including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), FT-IR, Raman spectroscopy, and solid-state NMR (as applicable).
Execute manual and automated high-throughput screening workflows. Prepare and characterize preclinical formulations (solutions, suspensions, solid dispersions, etc.) to enable in vivo studies.
Maintain accurate, detailed experimental records in electronic laboratory notebooks (ELN).
Document and interpret data to support regulatory filings and internal reports.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associate's degree and 4 years of Scientific experience OR
Bachelor's degree and 2 years of Scientific experience OR
Master's degree
Preferred Qualifications:
B.S. in Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Science, or a related scientific field, with at least two years of pharmaceutical/biotech industry experience.
Hands-on experience with solid-state and preformulation techniques.
Familiarity with data interpretation from XRPD, DSC, TGA, and spectroscopic methods.
Experience with high-throughput screening or automated liquid handling is desirable.
Strong attention to detail and commitment to data quality.
Effective communication and teamwork skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
85,306.00 USD - 103,484.00 USD
Auto-ApplyProcess Development, Associate Director - Cell Line Development (CLD), Biologics
Process engineer job in Boston, MA
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
Auto-ApplyDevelopment Operations Gift Processing Associate
Process engineer job in Boston, MA
Note: We are not currentlyreviewing new applications for this position. Please submit your application if you would like to be considered in the event that we re-open the candidate pool.
Project Bread connects people and communities in Massachusetts to reliable sources of food while advocating for policies that make food more accessibleso that no one goes hungry. To assist us in meeting our mission, Project Bread The Walk for Hunger is seeking a Development Operations Gift Processing Associate to join our team.
At Project Bread, we have a deep commitment to creating positive social change and recognize that hunger and racism are inextricably linked. We work in a fast-paced environment that values learning, innovation, and diverse perspectives. Knowing its centrality to our work, Project Bread is committed to equity and inclusion. We aspire to build a diverse team, including groups that are traditionally underrepresented among our sector leadership. We strongly encourage people of all backgrounds to apply.
Supervisor
: Director of Development Operations
Salary Range
: $55,000-$59,000
The Role:The Development Operations Gift Processing Associate supports the operation of Project Breads Development Office to maintain and improve the Raisers Edge NXT (RE NXT) donor database. This work is critical to ensuring that donor gifts are recorded with accuracy and care, which in turn strengthens donor trust and helps sustain Project Breads mission.
TheAssociate will be responsible for quick, accurate, and timely entry of gift information into the RE NXT database, ensuring donors feel valued and acknowledged through proper gift acknowledgments. They will also provide support the Development Operations Team, whose work underpins the success of all fundraising efforts across the organization. The ideal candidate will thrive in detail-oriented, behind-the-scenes work, and is eager to learn about nonprofit fundraising operations.
Primary Responsibilities:
Data Entry & Gift Acknowledgment
Accurately process all gifts in RE NXT, following coding guidelines for reporting.
Produce, manage, and mail acknowledgment letters and tribute cards.
Process matching gift requests, maintain portal logins, and respond to related inquiries.
Enter pledges and maintain tracking spreadsheets.
Maintain batch filing system and provide backup support during annual audit.
Provide backup support for Development Operations team members, including email inbox and Asana requests.
Database Integrity & Management
Maintain database integrity, security, and adherence to Project Bread policies.
Ensure accurate constituent records, including regularly updating donor information, running quarterly updates, and securing key contact details.
Design and execute procedures for regular database clean-up and quality assurance checks.
Development & Communications: Fundraising, Tracking, and Reporting
Sync online gifts with RE NXT and refresh related Power BI reports.
Assist with RE NXT reports, queries, and list pulls for mailings, appeals, email blasts, and event invitations, ensuring accuracy and alignment with strategy.
Support fundraising events and related activities.
Organizational Responsibilities:
Participate in the annual Walk for Hunger, held on the first Sunday each May,
including working as event staff the weekend of the Walk, attending pre-Walk events as assigned, and supporting Walk for Hunger fundraising efforts.
Participate in organization-wide events and meetings as assigned.
Qualifications:
There are innumerable ways to learn, grow, and excel professionally. We know people gain skills through a variety of professional, personal, educational, and volunteer experiences. We respect this when we review applications and take a broad look at the experience of each applicant. We want to get to know you and the unique strengths you will bring to the work. This said, we are most likely to be interested in your candidacy if you can demonstrate the majority of the qualifications and experiences listed below.
Priority Competencies:
Attention to Detail and Organization: Demonstrates strong attention to accuracy and quality, reviews content carefully, catches errors, and maintains organized systems. Effectively prioritizes and multitasks, and adjusts priorities as needed.
Growth Mentality: Focused on learning and improvement, open to coaching and training to support problem-solving. Seeks and engages well with feedback.
Problem Solving: Analyzes problems to identify probable causes; thinks of new possibilities; identifies critical issues and develops options for addressing them; able to incorporate other viewpoints as part of the process of creating solutions.
Additional Qualifications and Experience:
Prior professional experience, with a focus on development, gift processing, or database coordination.
Commitment to Project Breads mission of preventing and ending hunger in Massachusetts.
Skilled in working with data and databases, with the ability to quickly learn new technology platforms.
Proficient in Microsoft Office, especially Excel.
Highly organized, detail-oriented, and able to manage multiple priorities in a deadline-driven, service-focused environment.
Strong
interpersonal and communication skills (verbal and written), with cultural competence and emotional intelligence.
Able to work effectively both independently and collaboratively.
Additional Requirements:
Working Location: All employees are currently working a hybrid remote and in-office model and are expected to spend at least some time in the office each week. The Development Operations Gift Processing Associate will need to be present in the East Boston office on a regular basis, typically Tuesdays and Thursdays.
COVID-19 Vaccine Policy: For the safety and protection of Project Bread Staff & Constituents we do have a COVID-19 Vaccine Policy that requires all staff to be fully vaccinated per the CDC definition. Accommodation requests will be considered through our normal request process.
Benefits:
Benefits include health and dental, flexible spending accounts, retirement plan with match after one year, fully paid parental leave, life and long-term disability, contributions to commuting costs, professional development, and wellness expenses, and flexible paid time off.
Please apply by completing our application form and uploading your resume and cover letter in MS Word or PDF format.
Review of applications will begin September 22 and continue until the position is filled.
Project Bread is an equal opportunity employer and does not discriminate based on race, color, national origin, sex, religion, age, disability, sexual orientation, gender identity, gen-der expression, veteran status, height, weight, or marital status in employment or the pro-vision of services. Please contact us at ********************* if you would like to request special accommodations during the interview process.