Engineering Journal Jobs in Waban, MA

Boston, Massachusetts

Capital Planning Construction Administration

Full-Time Hybrid

Project Manager 1 - Construction Administration

Capital Planning

Reports To: Project Manager 3 Construction Administration

Exempt

Grade: 10

This Project Manager 1 position is a member of the MSBA's Construction Administration Team that manages MSBA-funded capital projects from design development through bidding, contract award, construction, commissioning, and project close-out. The Project Manager 1 works with a motivated team reporting to a Project Manager3 for major projects and repair projects. The Project Manager 1 works with public school districts and consultants as part of a MSBA team to ensure conformance with MSBA's policies, agreements, and practices for major projects and repair projects through design development, construction and final audit. The Project Manager 1 will also review district submittals that establish grants for the repair program.

• Monitor project schedules, budgets and scope for major construction and repair projects to ensure compliance with MSBA guidelines and funding agreements, and to track construction progress.
• Review monthly reimbursement requests for major construction and repair projects and recommend eligibility of project costs for reimbursement.
• Report on changes to the schematic design budget through the design development and bidding phases, process budget revisions, and review project cash flow for accuracy and variances.
• Review design development documents and prepare and issue review comments for major projects, identifying any variances to the agreed upon scope identified in the funding agreement.
• Review cost estimates, project scope and budget submittal to establish the grant for repair projects.
• Prepare and review change order documentation including recommendation of change order eligibility on major construction and repair projects.
• Review monthly project reports to understand submittal status, contract compliance, construction progress and identify variances. Utilize this information as well as lead site visits to inform MSBA reporting to the Board of Directors.
• Collaborate with the project team to review and make recommendations to improve MSBA processes and inform best practices for school construction.
• Lead in project meetings addressing project status, funding agreements, amendments and change orders.
• Collaborate with the project team to develop a schedule for the timely submittal of all final documents required for final audit of major construction and repair projects. Coordinate with the project team to resolve any outstanding items required and reconcile and approve the final payment.
• Participate in Capital Planning and Construction Administration subcommittees and procurement committees, on an as needed basis.
• Participate in the preparation, coordination and presentation of materials required for MSBA subcommittee, roundtables and Board of Director Meetings.

• Bachelor's degree in one of the following: project management, construction, architecture, engineering, or a related field.
• Two-to-five years of experience associated with construction, project management, building design or other applicable disciplines.
• Knowledge of construction project administration, contract compliance monitoring, change orders and construction methods.
• Proficiency in Microsoft Office software applications, including Excel, Word, PowerPoint and Outlook.
• Ability to effectively manage multiple tasks, involving complex and varying problems.
• Strong verbal and written communication skills.
• Demonstrated ability to gather, analyze, and present complex technical information in a clear, concise, and understandable manner.
• Ability to work both independently and as part of a team.
• Ability and willingness to travel occasionally to project sites.

$78,425 - $86,267 a year

This job description is intended to be general and will evolve over time. The description is subject to periodic updating. At management's discretion, the employee may be assigned different or additional duties from time to time.

The Director of Facilities and Grounds will provide strategic leadership and operational oversight for all Facilities, Vehicle Maintenance, and Land Operations at Juneberry Ridge. This role ensures our 750 plus acre regenerative farm, hospitality spaces, and infrastructure operate safely, efficiently, and sustainably while supporting the long-term growth of the organization.

This leader oversees two core teams, Facilities and Vehicle Maintenance and the Land Team, ensuring alignment in daily execution, asset stewardship, and long-range planning. The Director serves as a key member of the manager team, driving operational excellence, environmental stewardship, and cross departmental collaboration.

The ideal candidate is a hands-on, strategic leader with deep experience in facilities systems, land management, and team development who thrives in a dynamic, mission-driven environment.

Essential Duties and Responsibilities:

Leadership & Oversight

· Provide direct supervision and strategic guidance to the Facilities & Maintenance Lead and Land Team Supervisor.

· Develop departmental goals, staffing plans, and project schedules aligned with Juneberry Ridge's strategic vision.

· Champion a safety-first culture, ensuring compliance with OSHA standards and internal policies across all departments.

· Conduct regular team meetings, performance evaluations, and professional development planning.

· Promote environmental stewardship and operational excellence across all functions.

Operational Management

· Oversee preventative and reactive maintenance for facilities, vehicles, and equipment.

· Manage and optimize maintenance tracking and work order systems to ensure efficient scheduling, reporting, and follow-through.

· Direct land operations including landscaping, irrigation, erosion control, grading, timber management, and habitat stewardship.

· Collaborate cross-functionally (Hospitality, Farm, Events) to prioritize projects without disrupting guest experience.

· Develop and oversee farm-wide safety programs, emergency response plans, and equipment training.

· Establish and monitor key operational metrics including maintenance completion rates, equipment uptime, and resource utilization.

Financial & Resource Management

· Develop and manage departmental budgets, including materials and capital improvement planning.

· Approve and track purchase orders, invoices, and vendor payments.

· Manage contracts, service agreements, and vendor partnerships.

· Oversee asset inventory and lifecycle management for vehicles, equipment, and facilities.

Sustainability & Continuous Improvement

· Champion regenerative and sustainable practices in land care, waste management, water conservation, and energy efficiency.

· Identify and implement innovative solutions, including technology integration, fabrication opportunities, and strategic partnerships.

· Lead project planning, implementation, and long-term oversight.

Cross-Functional Collaboration

· Partner with executive leadership to plan and execute capital projects, renovations, and infrastructure upgrades.

· Support events, hospitality, and agricultural operations with logistical and technical expertise.

· Serve as point of escalation during emergencies, providing clear leadership and communication.

A Typical Day:

· Engaging across teams to identify challenges, design solutions, and actively lead implementation.

· Designing and building innovative systems and infrastructure to support a rapidly growing and evolving organization.

· Working directly toward improving ecological health indicators to restore and regenerate our 750 acres for people, animals, and the land.

Qualifications and Education Requirements:

· Associate or bachelor's degree preferred in Environmental Science, Plant Science, Ecology, Business Management, Operations, Engineering, Construction, or related field, not required.

· 7+ years of progressive experience in facilities, land management, or operations, with at least 5 years in a leadership role.

· Strong knowledge of facilities systems (HVAC, electrical, plumbing, mechanical)

· Strong knowledge of grounds/landscape maintenance and ecological land management practices.

· Proven experience managing teams across multiple disciplines (maintenance, landscaping, or equipment operations).

· Experience managing farm or workplace safety programs and ensuring regulatory compliance.

· Excellent leadership, communication, and organizational skills.

· Proficiency with Microsoft Office Suite and maintenance tracking systems.

· Ability to lift up to 50 lbs and work outdoors in variable weather conditions.

· Integrity, professionalism, and alignment with Juneberry Ridge's Mission, Vision, and Values.

DETAILS & BENEFITS

· Full-time, 45 hours per week, full benefits.

· Fully paid (no-premium) healthcare (individuals and families).

· Fully paid life insurance.

· Fully paid vision (individuals only).

· 18 PTO days + 8 recognized holidays.

Core Values at Juneberry Ridge:

· Be Joyful

· Integrity

· Pioneering

· Accountability in All We Do

· Learn, Educate, and Share

· Willful and Enthusiastic Stewardship

· Teamwork

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.

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

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

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.

Hiring for GxP Systems Development Engineer in Norwood, MA

Job Title: GxP Systems Development Engineer

Location: Norwood, MA

Role Overview

The GxP Systems Development Engineer supports the implementation, upgrade, and validation of laboratory informatics systems (e.g., SDMS, LIMS, ELN) in GMP-regulated environments. This role ensures system compliance, data integrity, and seamless integration with laboratory instruments.

Key Responsibilities

• Support implementation and upgrades of LogiLab SDMS, including deployment and instrument integration
• Execute validation activities (IQ/OQ/PQ), test scripts, and traceability documentation
• Collaborate with infrastructure and validation teams for system upgrades and performance
• Perform regression testing and system verification post-upgrade
• Assist with change control and maintain validation/SOP documentation
• Ensure compliance with ALCOA+ data integrity principles
• Support UAT, issue resolution, and system optimization with cross-functional teams

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
• 3–6+ years of experience with lab systems (SDMS, LIMS, ELN, CDS) in GMP environments
• Knowledge of GxP frameworks (GAMP 5, 21 CFR Part 11, Annex 11)
• Experience with system validation (IQ/OQ/PQ) and change control processes
• Hands-on experience with system upgrades or migrations
• Understanding of lab instrument integration and digital workflows
• Strong attention to detail and collaboration skills