Engineering Jobs in Everett Middlesex County Ma Online

Location: Woburn, MA (on-site 5 days per week)

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.

The Role:

The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies’ Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications.

Responsibilities:

Quality System and Computerized System Oversight

• Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities.
• Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption.
• Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management).
• Troubleshoot and resolve user issues as needed.

Documentation and Record Management

• Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS).
• Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements.
• Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements.
• Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations.

Training and Compliance Support

• Provide training and day-to-day support to employees on document control and system processes.
• Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections.
• Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered.
• 2–5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry).
• Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred.
• Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485).
• Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Industry: Pharmaceuticals

Title: Quality Assurance Associate II

Job ID: CAMB000111

Location: Cambridge MA (Hybrid)

Duration: 12 months contract (+Possibility of extension)

Duties

• Review of event documentation such as Batch records, Exceptions, and Regulatory filings
• Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
• Support design development plan including design verification and DHF deliverables
• Build and maintain Product Specification Files (PSF) for Clients program

Skills

• Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
• Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
• Demonstrated teamwork, initiative, and problem-solving skills
• Ability to prioritize and work independently with minimal supervision
• Ability to accurately determine deadlines and ask for help if needed
• Detail oriented with solid problem solving acumen.
• Ability to work effectively in a team environment with great organization skills.
• Ability to independently analyze and reconcile moderate to complex issues.
• Must have demonstrated initiative and accountability in a fast paced environment.
• Excellent verbal and written communication and interpersonal skills.
• Proficient with computers and word processing software (i.e., Microsoft Office products)

Education

• Minimum, a BS degree in life sciences, engineering or related field
• Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
• To have been involved on a device development project before as QA
• Signed off on design development plan, completed design verification, approved DHF deliverables
• Good understanding of FDA and EMA regulations and guidelines
• Excellent organizational, communication, and interpersonal skills.
• Preferred Quality Drug Substance manufacture experience

Life Sciences DeltaV Practice Leader

Role Overview

This role is responsible for building and scaling an organic Life Sciences DeltaV automation practice. The position is designed for a senior leader who can establish a new capability from the ground up, starting with initial talent acquisition and growing into a high‑performing team and standalone "mini business."

The successful candidate will lead technical delivery, shape best practices, support client growth, and take ownership of developing a sustainable DeltaV life sciences offering within a broader engineering and technology organization.

This is a highly entrepreneurial role that combines deep technical expertise, people leadership, and commercial accountability.

Key Responsibilities

Practice & Team Development

• Build and scale an organic Life Sciences DeltaV capability, starting with initial hires and expanding into a dedicated delivery team.
• Recruit, mentor, and develop DeltaV and automation engineers, setting standards for quality, delivery, and utilization.
• Establish scalable delivery models, including reusable libraries, templates, and methodologies to accelerate team productivity.
• Serve as the senior technical authority for DeltaV‑based life sciences automation work.

Technical & Delivery Leadership

• Lead complex life sciences automation projects, including greenfield, brownfield, and major DeltaV upgrade initiatives.
• Provide subject‑matter expertise in DeltaV batch automation and S88 concepts (recipes, phases, unit operations, equipment modules).
• Oversee the full automation lifecycle: URS, FDS/DS, configuration, FAT, SAT, commissioning, and support through IQ/OQ/PQ.
• Interface with adjacent systems such as MES, historians, data platforms, skids, and clean‑utility controls.

Client Engagement & Growth

• Act as a trusted advisor to client stakeholders across engineering, manufacturing, quality, and global SME teams.
• Support pre‑sales efforts, including technical solutioning, LOE development, scope definition, and client presentations.
• Help grow client relationships from initial engagements into multi‑site or long‑term programs.

Commercial & Entrepreneurial Ownership

• Take accountability for delivery performance, margins, utilization, and overall practice health.
• Contribute to scoping, SOW development, pricing awareness, risk management, and change‑order control.
• Operate with an ownership mindset, comfortable building from a low base and scaling responsibly over time.

Required Experience & Background

Core Experience

• 10-15+ years of experience in life sciences manufacturing environments, including biologics, sterile/aseptic, vaccines, or high‑potency facilities, with a strong GMP track record.
• 8-10+ years of hands‑on Emerson DeltaV experience in pharma or biotech, with progression from engineer to technical lead or manager.
• Recent experience delivering complex DeltaV projects (greenfield, brownfield, or major upgrades).

Leadership & Prior Roles

• Previous roles may include DeltaV Lead, Automation Manager, Senior Manager, or Associate Director within a pharma site, CDMO, or life‑sciences‑focused system integrator.
• Demonstrated experience managing technical teams and external vendors, including performance management and development.
• Proven ability to hire and build high‑quality automation teams and define what "good" looks like for billable DeltaV engineers.

Technical Expertise

• Deep understanding of batch automation and S88 architecture applied to biologics and aseptic manufacturing.
• Experience across the full validation lifecycle, including IQ, OQ, and PQ support.
• Familiarity with the broader automation ecosystem supporting regulated manufacturing environments.

Desired Attributes

• Maintains a strong professional network of DeltaV engineers, batch specialists, and control system SMEs that can be leveraged to build a team within 6-12 months.
• Comfortable creating standards, templates, and delivery frameworks that enable junior engineers to become productive quickly.
• Strong communicator who can work effectively with both technical and non‑technical stakeholders.
• Naturally entrepreneurial, motivated by building teams, capabilities, and long‑term value.

Location

• US‑based, preferably located in or near a major life sciences hub such as Boston/Cambridge, NYC/Northern NJ, Philadelphia, RTP, the Bay Area, Chicago, or the MD/DC corridor.

About the Company

Lumia is a well-funded startup building the next evolution in wearable health technology. We operate at the intersection of hardware, software, machine learning, and medical science - translating complex physiological signals into clear, actionable insights that help people better understand and manage their bodies. Our first mission was focused on improving the lives of individuals with dysautonomia and blood flow disorders, including POTS, ME/CFS, Orthostatic Hypotension, and Long COVID. These are all deeply underserved communities actively searching for better tools. As we scale, we are transforming into a general wellness wearables company - expanding reach and scope to new markets. Our founding team includes repeat entrepreneurs and ex-Bose engineers (our CEO’s last company was acquired by Bose, leading to the global launch of Bose Sleepbuds). We value rigor, ownership, velocity, and kindness. We are collaborative, high-performing, and serious about the work. The majority of the team is currently co-located in Boston, MA, with some remote roles. Opportunity for a remote role is dependent on the candidate and hiring manager approval.

About the Role

We are hiring our first Product Manager to own and scale the software experience that connects our wearable hardware to our members’ daily lives. This is not a feature-factory role. You will combine strategic thinking with hands-on execution to build engaging, habit-forming digital health experiences grounded in biometrics and real physiological data. You will work directly with the CEO, engineering, data science, and design to define roadmap, improve product operations, and translate complex sensor data into simple, meaningful insights. You will help establish the product function - including prioritization frameworks, release discipline, experimentation and user interview rigor, and product analytics foundations, all while shipping high-quality mobile and web features at a steady cadence.

Responsibilities

• Own the Software Roadmap and Development Lifecycle
• Partner with the CEO to shape and continuously refine the software roadmap, balancing near-term member value with long-term vision.
• Lead end-to-end product development: problem framing → wireframes → specs → sprint execution → QA → release.
• Write clear, well-scoped product tickets that reduce ambiguity and accelerate engineering velocity.
• Triage issues beyond surface-level symptoms by investigating root causes, proposing hypotheses, and suggesting solutions.
• Wearing and using the wearable daily to form first-person opinions on product priorities is part of the job.
• Manage release operations (Dev → Staging → Production), feature flags, and UAT.
• Define hypothesis-driven success criteria for each release, and evaluate features and usage.
• Lead the product marketing and GTM lifecycle of releases, partnering closely with Marketing.
• Build and refine light, scalable product operations processes to maintain clarity and alignment.
• Establish product strategy rhythms (quarterly planning, roadmap reviews, prioritization frameworks).
• Stay ahead of the competitive landscape in digital health, wearables, and remote diagnostics to inform future product strategy.
• Champion the User Experience
• Translate Lumia’s wearable capabilities into a cohesive, differentiated mobile experience.
• Deeply engage with members and patient communities to validate feature definitions and uncover unmet needs.
• Apply behavioral science principles to design habit-forming features, thoughtful in-app copy, and personalized experiences.
• Partner closely with Algorithm and Data Science teams to translate time-series biometric data and ML outputs into understandable, trustworthy insights.
• Define and track core KPIs (daily active wearers, retention, engagement, satisfaction).
• Instrument features and build dashboards, be able to define product analytics and maintain them.
• Partner closely with Support and Research to understand needs and build for success.

Qualifications

• 5 - 7 years of software product management experience.
• Strong mobile app product experience (iOS, Android, or cross-platform).
• Meaningful experience in wearables, biometrics, digital health, or health-tech strongly preferred.
• Experience building products that integrate with hardware or sensor-driven data.
• Demonstrated success shipping engaging, data-driven consumer products.

Required Skills

• Comfortable working with data and analytics as a product and collaborating with ML / algorithm teams.
• Familiar with core data science concepts (training/test sets, statistical significance, correlation, etc.).

Preferred Skills

• Thrive in ambiguity and bring structure to chaos.
• Operate with high ownership and accountability.
• Care deeply about clarity, prioritization, and execution quality.
• Motivated by impact and craftsmanship over titles.

Benefits Packages

• Equity upside
• Retirement plan (401k)
• Health, dental, and vision insurance reimbursement
• Commuter benefits
• Pastry Fridays

Interview Process

• Introductory Conversation (30 minutes)
• A conversation with the CEO to discuss your background, what excites you about Lumia, and high-level expectations for the role.

• Product Deep Dive (60 minutes)
• A slide-based presentation to stakeholders focused on a specific effort where:
• You detail what you’ve shipped (strategy, tradeoffs, metrics, what you’d do differently)
• How you approached an ambiguous problem space
• How you prioritized and made decisions under constraints
• Case Exercise (live: 60 min prep, 60 min together)
• You’ll be given some loose thoughts on an opportunity or idea and asked to bring initial structure, thinking, and proposal to the table for discussion with the team. We will email the scenario about 1 hour