Engineering Village Jobs in Somerville

269 positions found — Page 3

Lead AI Engineer
Salary not disclosed
Quincy, MA 4 days ago

Granite delivers advanced communications and technology solutions to businesses and government agencies throughout the United States and Canada. We provide exceptional customized service with an emphasis on reliability and outstanding customer support and our customers include over 85 of the Fortune 100. Granite has over $1.85 Billion in revenue with more than 2,100 employees and is headquartered in Quincy, MA. Our mission is to be the leading telecommunications company wherever we offer services as well as provide an environment where the value of each individual is recognized and where each person has the opportunity to further their growth and achieve success.


Granite has been recognized by the Boston Business Journal as one of the "Healthiest Companies" in Massachusetts for the past 15 consecutive years.


Our offices have onsite fully equipped state of the art gyms for employees at zero cost.


Granite's philanthropy is unparalleled with over $300 million in donations to organizations such as Dana Farber Cancer Institute, The ALS Foundation and the Alzheimer's Association to name a few.


We have been consistently rated a "Fastest Growing Company" by Inc. Magazine.


Granite was named to Forbes List of America's Best Employers 2022, 2023 and 2024.


Granite was recently named One of Forbes Best Employers for Diversity.


Our company's insurance package includes health, dental, vision, life, disability coverage, 401K retirement with company match, childcare benefits, tuition assistance, and more.


If you are a highly motivated individual who wants to grow your career with a fast paced and progressive company, Granite has countless opportunities for you.


EOE/M/F/Vets/Disabled

Job Description


We are seeking a highly skilled and experienced Lead AI Engineer to join our dynamic team. The ideal candidate will excel at identifying and articulating complex business problems, and will develop innovative, scalable, and robust AI/ML solutions to address these challenges. Responsibilities will include designing, building, and deploying enterprise-grade AI systems, specifically focused on:



  • Agentic AI solutions to automate operational processes (e.g., interpreting trouble tickets, performing basic troubleshooting, interacting with online portals, data entry).
  • Retrieval-Augmented Generation (RAG) and ColBERTv2 pipelines for parsing, indexing, and querying enterprise documents to facilitate answers related to process guidelines, product knowledge, and training materials.
  • Function calling solutions leveraging Large Language Models (LLMs) to automate and perform precise actions in enterprise workflows.
  • Developing and applying reinforcement learning strategies to optimize and automate decision-making processes within enterprise operations.

This role requires hands-on expertise with model fine-tuning, training pipelines, post-training optimization techniques (e.g., model distillation), classification models, and integrating AI systems within complex enterprise environments.



Duties and Responsibilities



  • Develop and implement AI solutions leveraging fine-tuned Large Language Models (e.g., OpenAI models, LLaMA, Mistral).
  • Design, develop, and optimize Retrieval-Augmented Generation (RAG) pipelines using advanced vector databases (e.g., FAISS, Pinecone, Milvus).
  • Build and enhance agentic AI systems utilizing frameworks like LangChain, AutoGPT, or similar automation frameworks.
  • Deploy scalable ColBERTv2 architectures for semantic retrieval and classification.
  • Create robust pre-processing and post-processing pipelines to enhance model performance, accuracy, and interpretability.
  • Collaborate closely with cross-functional teams, including product managers, business stakeholders, data scientists, and software engineers.
  • Implement best practices in model distillation, quantization, and optimization for deployment in production environments.
  • Ensure compliance with enterprise-grade security, privacy standards, and data governance practices.
  • Provide leadership and mentorship to team members, supporting their technical development and career growth through coaching, training, and performance feedback.
  • Drive timely and successful completion of AI/ML projects by setting clear milestones, tracking progress, removing blockers, and aligning resources

Required Qualifications



  • Bachelor's degree in Computer Science, Data Science, Machine Learning, AI, or related fields; advanced degree strongly preferred.
  • 5+ years of proven experience developing and deploying production-grade AI/ML systems.
  • Strong programming skills in Python, familiarity with libraries/frameworks such as PyTorch, TensorFlow, Hugging Face, and LangChain.
  • Demonstrated expertise with LLM fine-tuning (e.g., LoRA, PEFT), distillation, and model optimization.
  • Practical experience implementing RAG pipelines with embedding technologies and vector stores (e.g., FAISS, Pinecone).
  • Proven track record building agentic AI systems capable of interacting with multiple enterprise applications and platforms.
  • Solid understanding of NLP techniques, Transformer architectures, semantic search, and document retrieval technologies (e.g., ColBERT).
  • Hands-on experience with reinforcement learning techniques, including designing, training, and deploying reinforcement learning models.

Preferred Qualifications:



  • Master's or Ph.D. in Computer Science, Machine Learning, Artificial Intelligence, or related field.
  • Familiarity with cloud-based AI services (e.g., AWS SageMaker, Azure ML, Google Vertex AI).
  • Experience with containerization (Docker, Kubernetes) and deployment pipelines (CI/CD).
  • Knowledge of advanced AI frameworks and model inference engines such as Triton Inference Server, TensorRT, and ONNX.
  • Familiarity with model monitoring, observability tools, and techniques to ensure long-term reliability and performance.
  • Strong communication and interpersonal skills with the ability to clearly articulate complex technical solutions to non-technical stakeholders.
  • Experience in regulated industries or environments requiring strict compliance and data governance standards.
Not Specified
Senior Project Manager, Healthcare Construction
Salary not disclosed
Boston, MA 2 days ago

Sr. Project Manager

Location: Boston, MA (candidates must already reside in Massachusetts, preferably in the Boston area)

Schedule: 100% onsite at the main office or hospital project sites

Travel:

40–60% travel within approximately one hour of the main office to various hospital project sites. Mileage reimbursement provided.


Compensation

  • $128K–$155K base salary
  • Discretionary annual bonus
  • $452/month vehicle allowance
  • $80/month phone allowance


Overview

Large hospital construction project within the Boston metro area, consisting of multiple project sites.


Required Experience

  • 8+ years of project management experience with a mechanical subcontractor
  • Experience managing hospital construction projects valued at $5M+ (other commercial project types will not be considered)
  • Strong experience managing subcontractors, vendors, budgets, and client relationships


Education

Bachelor’s degree in Construction Management, Engineering, Architecture, or related field.

Equivalent HVAC or plumbing field experience may be considered.


Preferred Certifications

  • PMP (Project Management Professional) – PMI
  • Procore Certified
  • OSHA 30, CPR, and First Aid (preferred)


Key Responsibilities

  • Oversee all aspects of project delivery including financial management, subcontractors, vendors, and client relationships
  • Maintain job site safety through safety planning, JHA approvals, toolbox talks, and site walks
  • Manage project budgets and contract delivery types (GMP, Lump Sum, or Concession Agreement)
  • Ensure contract compliance including insurance, reporting, scheduling, and energy savings requirements
  • Oversee Procore project setup, including change management and document control
  • Negotiate and execute vendor purchase orders and subcontracts
  • Lead project handoff meetings and ensure alignment on project goals and client expectations
  • Oversee site utilization planning with emphasis on safety, cleanliness, and access control
  • Establish and manage the project baseline schedule and milestone tracking
  • Lead monthly project reporting, cost reviews, and risk mitigation planning
  • Ensure execution of the project quality assurance plan
  • Manage change processes including RFIs, drawing revisions, and client directives
  • Lead project meetings and distribute agendas and minutes
  • Build and maintain relationships with subcontractors, vendors, and clients
  • Manage and mentor Project Managers


Qualifications

  • 8+ years of relevant experience
  • Ability to manage multiple priorities and resolve project challenges effectively
  • Proficiency with Microsoft Office and Procore


Benefits

  • Medical, dental, and vision insurance
  • 401(k) with company match (100% of the first 3%, 50% of the next 2%)
  • 120 hours PTO and 9 paid holidays
  • Mileage reimbursement and monthly vehicle allowance.
Not Specified
CNC Lathe Machinist III ($30$45/hr)
✦ New
Salary not disclosed

Experienced CNC Machinists wanted! Join a stable manufacturing company with 40+ years in business. We are looking for a skilled CNC Lathe Setup/Operator who can produce precision components and support our growing production team.


What Youll Do
  • Set up and operate CNC lathes for production runs
  • Read and interpret blueprints and technical drawings
  • Inspect parts using calipers, micrometers, and precision measuring tools
  • Perform machine adjustments and basic troubleshooting
  • Work with engineering on CNC programs (Mastercam / CAM software)
  • Maintain quality standards through in-process inspections
  • Keep machines and work areas clean, safe, and organized



What Were Looking For
  • 510 years CNC machining experience
  • Strong experience with lathe setup and tooling
  • Experience with multi-axis / multi-spindle machines (Mazak, Puma, Miyano preferred)
  • Knowledge of GD&T and blueprint reading
  • Strong mechanical aptitude and problem-solving skills
  • High School Diploma or equivalent
Why Work With Us
  • Established company 40+ years in business
  • Competitive pay
  • Comprehensive benefits package
  • Stable full-time work
  • Opportunity to grow with an experienced manufacturing team

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Not Specified
Entry Level Data Engineer
✦ New
Salary not disclosed

Job Overview:

We are seeking a Data Engineer to support data pipeline development and ETL processes.

Responsibilities:

Build and maintain ETL pipelines

Optimize database performance

Work with structured and unstructured data

Ensure data integrity

Requirements:

Degree in Data Engineering or related field

Knowledge of SQL, Python

Familiarity with data warehousing concepts

Not Specified
Quality Engineer
✦ New
Salary not disclosed

Job Title : Engineering, Design, R&D - Quality Engineer

Location : Burlington, MA 01803

Duration : 06 Months

Job Description:

The Quality Engineer / Test Engineer supports product validation.

Update and create test protocols for new features.

Analyze test data using statistical methods in Excel and/or JMP and report on results in both Confluence and Jira.

Evaluate existing test methods and procedures to determine how they might be improved.

Complete documentation needed to support testing execution, including data capture forms and digital requests.

Compile reports on testing status across multiple programs to report to leadership, leveraging Jira data.

Review test plans and identify gaps as well as collaborate with multiple teams to confirm test completion.

Not Specified
Senior Project Engineer
✦ New
Salary not disclosed
Boston, Massachusetts 1 day ago

The Role

As Senior Project Engineer, you will work alongside senior project managers serving as owner's representative on behalf of a confidential defense tech client. You will be a critical part of the project delivery team, supporting the day-to-day execution of complex construction projects from the owner's side. This is a hands-on, high-visibility role with real exposure to executive-level clients and mission-critical work.

What You'll Own

  • Support senior PMs in managing proposals, drafting meeting minutes, contract creation, and client reporting documents
  • Assist in the creation and ongoing updates of project budgets and schedules
  • Manage document control, change order processing, monthly invoicing, TI allowance reimbursement, and project closeout in coordination with project managers
  • Day-to-day involvement across multiple concurrent, complex construction projects
  • Interface directly with PMs, clients, and brokers on evolving project requirements

What We're Looking For

  • 1-4 years of experience in the construction industry, preferably as a Project Engineer or Senior Project Engineer
  • Experience with tenant improvement projects required
  • Hands-on experience with invoice processing, schedule and budget creation and updates, and meeting minutes required
  • A strong tendency toward leadership and a solid understanding of the design, permitting, bidding, construction, and closeout process
  • Highly proficient in Bluebeam, Microsoft Excel, Microsoft Word, and Microsoft Project
  • Sharp communicator, written and verbal, comfortable interfacing with senior stakeholders
  • Self-directed and deadline-driven, with the ability to juggle multiple tasks and adapt quickly to shifting priorities

Compensation & Details

  • Competitive base salary commensurate with experience ranging from $80,000-$110,000
  • Competitive benefits package and long-term career growth
  • Combination of in-office and onsite project work
  • Travel as required to support client projects
  • Bachelor's degree required, preferably in Construction Management, Engineering, or Architecture
Not Specified
Travel Mammography Technologist
✦ New
Salary not disclosed
Newton Lower Falls, MA 1 day ago
Job Description

AMN Healthcare Allied is seeking a travel Mammography Technologist for a travel job in NEWTON LOWER FALLS, Massachusetts.

Job Description & Requirements

- Specialty: Mammography Technologist
- Discipline: Allied Health Professional
- Start Date: 04/05/2026
- Duration: 13 weeks
- 40 hours per week
- Shift: 8 hours
- Employment Type: Travel

Job Description & Requirements/n
/nMammography Tech - (Mam - Mammo Tech)/n
/nStartDate: 4/5/2026 /n/nPay Rate: $2905.00 - $2993.00 /n

/n13 week assignment in a busy Mammography department doing screening and diagnostic Mammography. State of the art equipment and procedures. Free on-site parking. Choose between 10-and 8-hr shift options on week days only. 40 hours/week./n

Required Qualifications
Mammography Technologist, Mammography
Licenses: RAD-MA
Certifications: BLS
SSN Required
DOB Required

covid and flu vaccine/n

Preferred Qualifications
current Massachusetts Imaging license for Mammography/n/n

Facility Location
Newton Lower Falls is a village of Newton, Massachusetts and is situated on the Charles River. The village is also home of the famous landmark known as the Lower Falls Wine Company and the well-known author Sarah Fuller, who taught Helen Keller. This area is now a suburban neighborhood and located close to the park at the old Hamilton elementary school and bordered on the northwest by the Leo J. Martin public golf course. /n

/nJob Benefits/n
/nAllied travel assignments are typically for 13 weeks and offer generous packages that include:

- Competitive pay rates
- Medical, Dental, Vision
- 401(k) and Flex Spending
- Life Insurance
- Accident and Short-term Disability Coverage
- Free Continuing Education
- Competitive Housing Deal
- Refer a friend and earn extra cash!

/n

/nAbout the Company/n
/nAt AMN Healthcare, we strive to be recognized as the most trusted, innovative, and influential force in helping healthcare organizations provide quality patient care that continually evolves to make healthcare more human, more effective, and more achievable./n

mammography technician, mammography tech, mammogram technician, mammogram tech, mammography, mammographer, breast care, mammogram, allied health, allied/n

AMN Healthcare Allied Job ID #3464866. Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Mammography Tech - (Mam - Mammo Tech)

About AMN Healthcare Allied

AMN Healthcare is a leading force in the healthcare industry, committed to being the most trusted, innovative, and influential partner for healthcare organizations. With a focus on providing quality patient care, AMN Healthcare offers holistic solutions that reduce costs, streamline processes, and improve efficiencies. The company boasts over 30 years of experience and takes pride in staffing leading healthcare facilities with the nation's best travelers. As an industry leader, AMN Healthcare offers a diverse team dedicated to supporting healthcare workers and facilities, ensuring a personalized and supportive experience for both clients and candidates.

Visit for more information.

Benefits

- Company provided housing options
- Medical benefits
- Dental benefits
- Continuing Education
Not Specified
Lead, Electro-Optical (EO) Systems Engineer
✦ New
$127,500 - 236,500
Melrose, MA 1 day ago

During its 120-year history, L3Harris has transformed communications and information technology.

L3Harris is a proven leader in tactical communications, geospatial systems and services, air traffic management, environmental solutions, avionics and electronic warfare, and space and intelligence.

From ocean to orbit and everywhere in between, we provide mission-critical solutions to connect, inform and protect the world.

On the L3Harris team, your job is to secure the world.

We don't work here just for the advanced technology and equipment: we work here because we know what
- and who
- we're protecting! From families to the intelligence community, and from our climate to our men and women in uniform
- we're making the world a safer place! L3Harris Space Superiority group has an opening for a Lead, Systems Engineer to join our team of qualified, diverse individuals.

This position will be in Wilmington, MA.

The individual will work in a fast-paced environment with high expectations, significantly diverse assignments, and a collaborative team setting.

The L3Harris AgileEO Systems Engineering department is seeking a systems engineer to join our team and support one of our newer programs.

AgileEO specializes in space-based, small aperture visible and IR telescopes with integrated electromechanical devices used for motion and focus control.

The successful candidate will support the program technical leads (Lead or Chief Systems Engineer, IPT Lead) by performing technical analysis, managing specifications, and generating design review and technical documents.

Additional responsibilities include supporting the test and design verification, requirements sell off, end item data package (EIDP) generation efforts.

Essential Functions: Coordinate with program leadership to develop a technical plan and path forward for program execution.

System Design and Integration: Develop and integrate advanced electro-optical systems for space-based applications, ensuring compliance with all relevant specifications and mission requirements.

Technical Leadership: Provide technical leadership and guidance in the areas of systems engineering, including architecture development, requirements analysis, and verification and validation (V&V).

Requirements Management: Define, manage, and maintain system and sub-system level requirements, ensuring traceability and compliance throughout the project lifecycle.

Modeling and Simulation: Conduct modeling and simulation activities to predict system performance and behavior under various operational scenarios.

Project Execution: Lead and coordinate multidisciplinary engineering teams throughout the project lifecycle, from conceptual design to final system delivery and operation.

Documentation and Reporting: Generate and maintain detailed technical documentation, including system specifications, design descriptions, test plans, and test reports.

Customer Requirements: Translate the voice of the customer into system level requirements and evaluate alternative solutions to establish preliminary system designs.

Trade Studies: Develop and evaluate trade studies for accuracy and completeness to support decision-making processes.

Identify and solve problems using logical engineering thought processes.

Stakeholder Communication: Communicate effectively with internal and external stakeholders, including subcontractors and U.S.

Government customers, to ensure alignment and project success.

Standards Compliance: Ensure all engineering activities adhere to industry standards, regulatory requirements, and best practices.

Collaboration: Work effectively in a team environment and collaborate with multidisciplinary teams to achieve project goals.

Training and Mentoring: Provide training and mentorship to junior engineers, fostering their development and growth within the team.

Qualifications: Bachelor's degree in Engineering, Physics, or other related scientific discipline and 9 years of relevant space-based EO/IR systems engineering work experience.

A graduate Degree and a minimum of 7 years of prior related experience.

In lieu of a degree, minimum of 13 years of prior related experience.

Experience as a Control Account Manager (CAM) and Integrated Product Team Lead (IPTL) is required 6 years experience in electro-optics, including experience with optical design, sensors, detectors, and imaging systems 6 years experience working with engineering and simulation software tools, such as MATLAB Candidate must be eligible to obtain a DOD Secret security clearance Preferred Additional Skills: Holds an active Secret or Top Secret/SCI clearance Demonstrated experience with space systems engineering, including knowledge of space environments, satellite systems, and space mission design Experience in leading technical teams, managing projects, and coordinating cross-functional engineering activities Relevant professional certifications, such as INCOSE Systems Engineering Professional (SEP) certification, are a plus Proficient in Model Based Systems Engineering (MBSE) tools such as DOORs, CAMEO, CREO, JIRA and SysML Excellent verbal and written communication skills, with the ability to clearly convey complex technical information to diverse audiences Strong analytical and problem-solving abilities, with a proven track record of tackling complex engineering challenges Ability to work effectively in a team environment and collaborate with multidisciplinary teams to achieve project goals In compliance with pay transparency requirements, the salary range for this role in California, Massachusetts, New Jersey, Washington, and the Greater D.C, Denver, or NYC areas is $127,500.00
- $236,500.00 .

This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location.

L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays.

The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements.

L3Harris Technologies is proud to be an Equal Opportunity Employer.

L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination.

All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws.

L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law.

Please be aware many of our positions require the ability to obtain a security clearance.

Security clearances may only be granted to U.S.

citizens.

In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.

L3Harris Technologies is an E-Verify Employer.

Please click here for the E-Verify Poster in English or Spanish .

For information regarding your Right To Work, please click here for English or Spanish .

permanent
Consumer Product Manager
✦ New
Salary not disclosed
Burlington, MA 1 day ago

Senior Systems Engineer – Consumer Product Development

Location: Burlington, MA (Hybrid – minimum 3 days onsite)

Salary Range: $76,400 – $140,000 annually

Travel: 10–20% international travel


Position Overview

A leading consumer products organization is seeking a Senior Systems Engineer to support the development of innovative, high-volume consumer products. This role will serve as the technical product owner for cross-functional engineering teams, ensuring product requirements, performance, cost targets, and development schedules are successfully achieved.

The position works closely with global development teams and manufacturing partners to guide products from concept and development through validation and production readiness. The ideal candidate will bring strong experience in systems engineering, product architecture, and cross-functional technical leadership within consumer product development environments.


Key Responsibilities

Translate consumer and stakeholder needs into detailed system and product requirements.

Develop system architectures that support product functionality and performance goals.

Decompose system-level requirements into subsystems, modules, and components, ensuring alignment across engineering teams.

Manage interfaces between subsystems and coordinate with platform owners and engineering leads.

Support innovation initiatives and R&D activities required to meet product performance and development goals.

Participate in risk assessment, mitigation strategies, and validation planning throughout the product development lifecycle.

Apply structured engineering methodologies such as DMAIC, LAMDA, or similar frameworks to guide development processes.

Use data-driven decision-making and statistical analysis tools to support product design and testing.

Support prototype development, testing activities, and validation efforts during product development.

Communicate development progress, risks, and milestones to internal stakeholders and leadership teams.

Contribute to continuous improvement initiatives that enhance engineering processes and product development workflows.


Required Qualifications

Bachelor’s or Master’s degree in Engineering or a related technical discipline.

10+ years of engineering experience, preferably in high-volume consumer product development environments.

Experience in systems engineering, product architecture, and cross-functional technical leadership.

Knowledge of design validation planning, DFMEA processes, and risk analysis methods.

Experience using statistical analysis tools such as JMP, Minitab, R, or similar platforms.

Advanced experience with 3D CAD modeling tools (SolidWorks preferred).

Hands-on experience with prototyping, test fixture development, and experimental validation.

Strong communication and collaboration skills to work effectively across engineering, manufacturing, and product teams.


Preferred Qualifications

Six Sigma Green Belt or Black Belt certification.

Familiarity with systems modeling methods and finite element analysis concepts.

Experience working with global engineering teams and contract manufacturers.

Ability to support international collaboration and travel as needed.


Compensation & Benefits

Competitive salary range: $76,400 – $140,000 per year depending on experience and qualifications.

Annual performance-based bonus eligibility.

Comprehensive medical, dental, and vision insurance plans.

401(k) retirement plan with company match.

Paid time off, including vacation, sick time, and paid parental leave.

Short-term and long-term disability coverage.

Tuition reimbursement and professional development support.

Additional employee benefits and wellness programs.



Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Not Specified
Senior Manufacturing Engineer
✦ New
Salary not disclosed
Woburn, MA 6 hours ago

Salary Range: 167k - 211k


Title: Senior Manufacturing Engineering Manager


Company Description

Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied 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.


The Manufacturing Engineering Manager is responsible for building and leading a high-performing Manufacturing Engineering organization supporting Phase 2 and Phase 3 clinical manufacturing of a highly automated pharmaceutical–medical device combination product manufactured in ISO Class 5 isolator environments and will report to the VP of Manufacturing.


This role provides technical leadership for process development transfer, equipment integration, MES/electronic batch record implementation, validation execution (IQ/OQ/PQ), and establishment of scalable GMP manufacturing systems. The position requires strong problem-solving capability, hands-on leadership, and the ability to operate effectively within a fast-paced startup environment transitioning to late-stage clinical readiness.


Responsibilities

  • Build, lead, and develop a team of manufacturing engineers and engineering technicians. Recruit, mentor, and performance-manage engineering staff and manufacturing technicians.
  • Develop training frameworks for GMP technicians and operators supporting highly automated production lines.
  • Lead transfer and integration activities of highly automated manufacturing systems, including custom automation and OEM equipment.
  • Develop and execute Master Validation Plans (MVPs) covering facilities, utilities, process equipment, and ancillary systems for operation in Grade A/ISO Class 5 isolator-based manufacturing environments.
  • Lead generation, review, and approval of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols
  • Collaborate cross-functionally to ensure traceability between URS, design specifications, FAT/SAT, and qualification protocols.
  • Oversee implementation and lifecycle management of, Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Equipment data acquisition systems, Integrated automation platforms
  • Develop SOPs, work instructions, maintenance procedures, and engineering documentation to support validated operations.
  • Lead structured root cause investigations (e.g., deviation investigations, CAPAs, equipment failures, yield excursions).
  • Apply engineering rigor and statistical methods to improve process capability and equipment performance.
  • Scale processes from early clinical manufacturing through Phase 3 readiness, ensuring process robustness and repeatability by the implementation of KPIs for, OEE, Throughput, Yield, Deviation rate, Batch release cycle time, Validation execution timelines
  • Partner with Quality, Regulatory, and Supply Chain to ensure phase-appropriate compliance and scalability.
  • Foster a culture of accountability, urgency, technical rigor, and continuous improvement driving operational readiness for increasing clinical demand.


Qualifications

  • Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related discipline (Master’s preferred).
  • 8–12+ years of experience in pharmaceutical, biotech, or medical device manufacturing.
  • Minimum 3–5 years of people management experience leading engineers and/or technicians.
  • Direct experience supporting Phase 2 and/or Phase 3 clinical manufacturing environments with combination products, polymer processing and / or unique drug releasing processes/products.
  • Demonstrated experience with: Master Validation Plan development, IQ/OQ/PQ execution, Process validation, GMP documentation systems and MES and electronic batch record implementation.
  • Experience with highly automated manufacturing lines and equipment integration.
  • Experience operating within Grade A/ISO Class 5 or aseptic/low bioburden environments.
  • Demonstrated success in startup or rapidly scaling manufacturing environments.


Preferred Qualifications

  • Experience with drug–device combination products.
  • Experience in isolator-based manufacturing systems.
  • Knowledge of 21 CFR Parts 210/211, 820, and Part 11 requirements.
  • Strong understanding of validation lifecycle management and risk-based qualification strategies.
  • Experience implementing KPI-driven manufacturing organizations.
  • Lean/Six Sigma certification or equivalent process improvement background.


Core Competencies

  • Strategic yet hands-on technical leadership
  • Strong project management and cross-functional coordination
  • Structured problem solving and risk assessment
  • Ability to balance speed and compliance in a startup setting
  • High energy, adaptability, and resilience
  • Clear communicator with executive-level reporting capability


Not Specified
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