Engineering Structures Jobs in Auburndale, MA

*FULL TIME ROLE

Excited to announce that we're once again working with a global client that is looking to expand it's sales team with a new experienced hire in Boston.

For this position, we're looking for a well-versed individual with proven CAPEX sales experience to the life sciences who can build upon an already existing territory by winning repeat business and new clients in Boston.

Responsibilities

• Manage and maintain client relationships in the life sciences in the Boston area as well as Virginia and Washington.
• Prospect and target potential clients in this territory.
• Manage and deliver a pipeline full of opportunities in the life sciences market.
• Serve as a key point of contact for clients and coordinate with internal stakeholders to manage expectations.
• Identify potential expansion opportunities through market research and client relationships.

Qualifications & Requirements

• Bachelor's degree in relevant markets such as Chemistry and/or Engineering.
• 5+ years of life science experience.
• 5+ years of sales experience in the life sciences.
• Valid US Driver's license.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

Senior Technical Support Engineer

Location: San Francisco, CA | Raleigh, NC | Dallas, TX | Boston, MA

Schedule: Hybrid – 3 days onsite required

Employment Type: 6-Month Contract-to-Hire

Pay Rate: $65–68/hour

Start Date: ASAP

About the Role

The Technical Solutions team is focused on advancing care and research innovation. We support new business initiatives by expanding product capabilities in strategic areas and delivering a scalable technical support framework across multiple product portfolios.

As a Senior Technical Support Engineer, you will partner closely with internal stakeholders to identify, reproduce, troubleshoot, and resolve complex technical issues. You will support infrastructure, permissions, and configuration changes while delivering high-level technical support and sustaining engineering services that help customers achieve meaningful business outcomes.

This role offers the opportunity to collaborate with customers, developers, architects, and operations teams to solve challenging, high-impact problems. You will also contribute to building support tooling and infrastructure to improve operational efficiency.

Travel up to 10% may be required.

Key Responsibilities

• Own and manage technical customer issues from identification through full resolution
• Reproduce and troubleshoot complex technical problems, including reviewing and analyzing code to determine root cause
• Project manage new client deployment issues through to completion
• Implement infrastructure, security, and permissions configuration changes
• Drive operational efficiencies by identifying improvements in process, tooling, and product functionality
• Develop playbooks and knowledge base documentation to streamline issue resolution
• Create internal reports and dashboards for issue tracking and performance monitoring

Minimum Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Mathematics, Statistics, or related field
• Cloud operations experience (creating buckets, virtual machines, and managing security access controls/IAM)
• 3+ years of experience with Python or another object-oriented programming language
• 3+ years of experience working with SQL
• Experience troubleshooting data-related issues
• Proficiency with GitHub and Jira
• Strong troubleshooting skills with the ability to track complex technical details
• Excellent communication skills with the ability to translate technical findings for both senior developers and non-technical stakeholders

Preferred Qualifications

• 4+ years of experience in healthcare technology
• Experience supporting highly regulated software environments
• Experience with R
• Infrastructure-as-Code (IaC) experience such as Terraform, Ansible, or similar tools
• Self-starter mindset with strong ownership and a passion for driving issues through to resolution

W-2 employees only. No 3rd parties.

• 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
• 3+ years leading AI/ML or advanced analytics initiatives.
• Experience in regulated industries (Pharma, Biotech, Medical Devices).
• Strong understanding of AI/ML lifecycle and data governance.
• Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
• Strong stakeholder management and executive communication skills.

Salary range: 60k - 80k

Title: Operations Associate, Facilities

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room 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 the global vaccine and therapeutic market. Vaxess Manufacturing Tour

Responsibilities

• Provide support for the overall lab environment, ensuring proper functioning of utilities, lab equipment and life
• safety systems
• Perform facility & safety inspections including chemical, biological and universal waste consolidation
• Perform equipment installations, qualifications and calibrations for lab & facility equipment/casework
• Provide support to various facilities administration duties including but not limited to external vendor
• coordination, landlord services, HVAC, plumbing, etc.
• Provide support to consumable, chemical and off-site storage inventories
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Maintain necessary certifications DOT, RCRA, Bloodborne Pathogens, etc.

Qualifications

• 2-4 years’ experience as on-site technician working in an industrial R&D, Quality Control or Manufacturing lab
• Highschool Diploma/GED is required, BS in STEM degree is a plus
• Ability to lift 50 Lbs. & work across multiple sites
• Familiarity with Lab standards, compressed gas and laboratory utilities, generators, HVAC, IT & access control
• Familiarity or experience working in GxP, a cleanroom and/or a biomedical laboratory environment
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated ability to build, repair and maintain equipment, fixtures and furniture
• 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

Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08545

Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Key Requirements and Technology Experience:

• Key skills: - Purification experience/ Protein Purification Chromatography
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
• Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
• Protein purification chromatography
• Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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About the Role

The ideal candidate has hands-on experience in Cesium chloride (CsCl) density gradient ultracentrifugation, ion-exchange chromatography, affinity purification, and tangential flow filtration (TFF), with a strong understanding of purification principles and data analysis.

Responsibilities

• Execute purification processes including CsCl density gradient ultracentrifugation, affinity chromatography (e.g., AVB, CaptureSelect), ion-exchange chromatography (AEX, CEX), and other polishing steps.
• Operate AKTA systems (Avant, Pure, or Pilot) for small- to large-scale purification runs.
• Perform TFF operations for buffer exchange and concentration of intermediate or final products.
• Support experimental design, data collection, and documentation following established procedures and GMP/GLP best practices.
• Assist in troubleshooting and optimization of purification processes.
• Analyze in-process and purified samples using relevant analytical methods (e.g., UV, SDS-PAGE, ddPCR, ELISA, or HPLC).
• Collaborate cross-functionally with upstream, analytical, and manufacturing teams.
• Maintain lab equipment, manage buffers and column inventory, and ensure compliance with safety and documentation standards.

Qualifications

• Education: Master’s degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• Experience: Minimum 2 years of hands-on purification experience in an academic or industry setting.

Required Skills

• Strong knowledge and practical experience with CsCl density gradient ultracentrifugation, ion-exchange, and affinity chromatography.
• Familiarity with buffer preparation.
• Understanding of basic analytical methods for product characterization.

Preferred Skills

• Strong attention to detail and excellent documentation habits.
• Effective communication and teamwork skills.
• Ability to manage multiple tasks and meet project timelines.

Preferred Qualifications

• Experience in AAV or other viral vector CsCl density gradient and column purification.
• Experience with AKTA systems and Unicorn software.

Location: Boston + Somerville, MA

Type: Full-time

Reports to: Project Manager and VP of Real Estate

Role Summary

Rafi Properties is seeking an Assistant Construction Project Manager (ACPM) to support planning, coordinating, and executing construction projects from pre-construction through completion. This role ensures that projects are completed on time, within budget, and in compliance with safety and quality standards. The ACPM acts as a liaison between stakeholders, tenants, subcontractors, vendors, and on-site personnel. 

Key Responsibilities:

Project Planning & Coordination

• Assist in developing and maintaining project schedules and work plans.
• Coordinate with architects, engineers, consultants, and contractors to ensure timely delivery of project milestones.
• Organize and attend project meetings, record minutes, and follow up on action items.

Documentation & Reporting

• Manage project documentation, including contracts, RFIs, submittals, change orders, and drawings.
• Maintain up-to-date records of daily progress reports, meeting notes, and project correspondence.
• Track and update project budgets and cost reports in collaboration with the Project Manager.

Procurement & Vendor Management

• Assist in sourcing and procuring materials, equipment, and subcontractor services.
• Issue purchase orders and manage vendor/subcontractor invoices in accordance with budget.
• Follow up with suppliers and subcontractors to ensure timely delivery of goods and services.

Site Coordination & Quality Control

• Conduct regular site visits to monitor progress, safety, and quality control.
• Work with superintendents and site supervisors to resolve on-site issues.
• Ensure adherence to safety regulations and company policies.

Risk Management

• Identify potential issues or delays and work with the Project Manager to resolve them.
• Assist in preparing and implementing risk mitigation plans.

Qualifications:

Education & Experience

• Bachelor’s degree in Construction Management, Civil Engineering, or related field preferred.
• 3–5 years of experience in construction project coordination or management.
• Experience in construction and owner’s project management is a plus.
• Up to 60% travel required from site-to-site as required by projects.
• Valid driver’s license required.

Skills & Competencies

• Strong organizational and time-management skills.
• Excellent written and verbal communication.
• Ability to read, interpret, and value-engineer construction drawings and specifications.
• Proficiency in construction management software (e.g., Procore, Buildertrend, MS Project) and MS Office Suite.
• Familiarity with construction contracts (AIA, GMP, etc.) is a plus.

Why Rafi Properties 

Rafi is a global real estate owner, operator and investor with HQ in Boston and Hong Kong. We believe today’s market rewards those who can think institutionally while acting nimbly. We move with urgency when opportunity presents itself and exercise patience when long-term value demands it. In a rapidly changing world, flexibility, discipline, and a long-term mindset are core to how we create alpha — and to the people we look to build with us.

Interested candidates should submit resumes to: