Engineering Jobs in Saugus Massachusetts

#2588 IT Business Partner - GMP Manufacturing Operations

Company and Role

Company is a publicly traded global pharmaceutical company with strong roots in the United States.

The IT Business Partner - GMP Manufacturing Operations will lead all technology implementation, production support, and maintenance activities within the Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS.

Expectations

• Own and foster the IT-to-business relationship for Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
• Define and manage a support and operating model for the Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Provide oversight and expertise in Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, TrackWise Digital.
• Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
• Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Oversee onboarding of new equipment into Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Company, introducing process improvements and leveraging industry learnings.

Experience

• Bachelor’s degree in computer science, Information Systems, Engineering, or related field.
• Minimum of ten (10) years’ IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
• Proven experience managing IT vendor relationships and service providers in a regulated environment.
• Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
• Demonstrated experience in configuring IT components for manufacturing equipment and writing user requirements
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.

Preferred Experience

• Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Hands -on experience: onboarding and installing pharmaceutical manufacturing equipment, configuring the systems for the equipment and writing the user requirements.

Benefits

• Medical, Dental, Vision benefits
• Short Term and Long Term Disability
• Generous PTO, Holiday Schedule and Company Shut Downs
• Annual Bonus Potential
• Recipient of “Best Places To Work” multiple times for a positive corporate culture.

• Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of products.
• Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables.
• Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes.
• Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards.
• Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.
• Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production.
• Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes.
• Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.
• Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC.
• Represent externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers.
• Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation.
• Perform other tasks and duties as assigned/required.
  
  

• BS in Mechanical Engineering or related engineering discipline required.
• 10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.
• Are you ready to take the next step in a career that’s both challenging and deeply rewarding? If you have a background with
• Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.
  
  

• Advanced degree preferred.
• Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design.
• Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding).
• Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling.
• Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred.
• Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones.
• Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams.
• Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders.
• Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities.
• Ability to work independently with high competency, while also driving and coordinating team-based execution.
  
  

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan
  
  

OPT Industries ( ) is a venture-backed MIT spinoff company that is focused on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products – everything from electrical components to luxury fashion.

Position Summary: Own and improve the reliability of production equipment by troubleshooting and sustaining electromechanical, controls, and firmware-adjacent systems across OPT’s manufacturing floor.

Key Responsibilities:

• Own and develop Python-based control, test, and automation systems.
• Debug and extend ATMega embedded C/C++ (incl. hardware-software interfaces, IP networks)
• Build and maintain hardware-software interfaces for sensors, motors, actuators, and data acquisition systems.
• Design test infrastructure, logging, and fault detection to support production uptime and repeatability.
• Update equipment, documentation, training, and maintenance procedures to prevent recurrence
• Support troubleshooting and urgent production issues on aggressive timelines

Qualifications:

• 5+ years of relevant experience, or 3+ years plus a Master’s degree in robotics, mechatronics, EE, CS, or a related field.
• Strong Python background with experience in hardware control, automation, or test systems.
• Hands-on experience with electromechanical systems: motors, encoders, sensors, power electronics, and control loops.
• Working knowledge of embedded C for microcontroller-based systems
• Comfortable using Bash / Linux environments for scripting, debugging, and system operations.
• Experience supporting systems in a production or manufacturing environment is a strong plus.

OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Hexagon Multivista is seeking a driven Account Executive with a hunter mentality to sell innovative digital workflow and geospatial solutions to AECO businesses. These companies typically generate $50 million to $1 billion in annual revenue and employ between 100 and 2,000 staff.

As part of Hexagon, you will play a critical role in generating new business, managing client relationships, and supporting client success across dynamic construction and technology markets.

Key Responsibilities

• New Business Acquisition:
• Prospect, qualify, and close new (net-new logo) accounts within the market segment.
• Sales Pipeline Management:
• Build and maintain a robust pipeline of potential and active clients to meet or exceed sales quotas.
• Client Relationship Management:
• Develop, grow, and maintain strong relationships with key client stakeholders, acting as a trusted advisor.
• Sales Cycle Management:
• Drive deals through the entire sales cycle, from initial outreach to negotiation and close.
• Product Demonstration:
• Effectively communicate product value, demonstrate workflows and solutions to potential clients, and tailor presentations to business outcomes.
• Cross-Functional Collaboration:
• Work with sales development, product, engineering, consulting, and customer success teams to deliver value and ensure customer satisfaction.
• Customer Feedback:
• Serve as the voice of the customer—gather and share feedback to drive product and service improvements.
• Reporting & Forecasting:
• Accurately track, forecast, and report sales pipeline progress and revenue using tools such as HubSpot, Salesforce, and others.
• Deliver Solutions:
• Present high-impact sales presentations, proposals, and solutions aligned to customer needs and project priorities.
• Market Engagement:
• Attend industry events, trade shows, and client meetings to grow the pipeline and increase brand awareness.
• Stay Informed:
• Maintain a strong understanding of market trends, industry developments, and the competitive landscape.

Key Skills & Qualifications

• 3+ years of B2B enterprise software or technical solution sales, ideally in construction, geospatial, manufacturing, or related fields.
• Proven record of full-cycle sales success—prospecting, negotiation, closing, and exceeding assigned quotas.
• Excellent verbal, written, and presentation skills—able to engage C-suite stakeholders and technical buyers alike.
• Strong proficiency with CRM (HubSpot, Salesforce) and sales engagement tools.
• Drive and self-motivation; able to operate independently in a fast-paced and growth-driven environment.
• Consultative, problem-solving approach and ability to build trust.
• Technical aptitude and willingness to stay current on new products, workflows, and digital solutions.
• Bachelor’s degree preferred.

Join Hexagon Multivista’s innovative sales team and help AECO businesses transform operations with industry-leading capture, analysis, and project management technologies.

USA

We are an equal opportunity employer. We do not discriminate on the basis of age, gender, gender identity or expression, sexual orientation, disability, ethnicity, nationality, religion, marital status, or any other protected characteristic. All qualified applicants are encouraged to apply.

Title: Senior Technical Support Engineer (Care Delivery)

Employment Type: 6-Month Contract-to-Hire

Start Date: ASAP

Work Model: Hybrid – 3 days onsite required

Eligible Locations: Boston, MA | Raleigh, NC | Dallas, TX | Waterloo, Ontario (Canada)

Compensation: 65-68/hr

About the Role

We are hiring a Senior Technical Support Engineer to support a complex production application environment focused on care delivery workflows. This is a hands-on troubleshooting role for someone who enjoys diagnosing real system problems — not a developer stop-gap role.

You will investigate live production issues, analyze application behavior, read backend code, execute SQL queries, and either resolve problems directly or partner with engineering teams to drive fixes.

The ideal candidate is a career technical support professional who takes ownership of issues and thrives in a high-impact operational environment.

What You’ll Do

• Reproduce and diagnose complex production issues
• Read and interpret object-oriented backend code
• Execute advanced SQL queries to validate system behavior
• Identify root cause and resolve issues when possible
• Escalate bugs to engineering with clear technical documentation
• Support ongoing operational stability of the platform
• Work within ticketing systems to manage incidents
• Improve support tooling and workflows
• Collaborate cross-functionally with engineering and operations teams

Required Qualifications

Technical

• Strong object-oriented programming background in Java, Go, or Python (must be strong in at least one)
• Advanced SQL querying skills
• Application-level troubleshooting experience
• Ability to read and debug code (not just run scripts)
• Experience working within ticketing/incident systems

Preferred Qualifications

• Experience as a Senior/Staff/Principal Technical Support Engineer
• Python scripting or automation experience
• Exposure to AI workflow optimization
• Healthcare or life sciences industry experience (nice to have)

Ideal Candidate Profile

• Senior application support engineer (career support track)
• Comfortable reading production code daily
• Strong ownership mindset — drives problems to resolution
• Not a developer seeking a temporary role
• Enjoys deep troubleshooting and operational stability work

Additional Details

• 6-month contract to hire
• Hybrid (3 days onsite required)
• Candidates must reside in Boston, Raleigh, Dallas, or Waterloo
• Immediate start preferred

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 Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling.
• Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities.
• Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards.
• Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation
• Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1–3 years of relevant mechanical testing or QC experience, or a master’s degree with applicable laboratory experience.
• Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems.
• Demonstrated proficiency in tensile, compression, shear, puncture, and force–displacement mechanical characterization.
• Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products.
• Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+).
• Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation.
• Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

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  

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 Engineer I / II will support Quality Assurance activities for Vaxess’ combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4).

Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.

Responsibilities:

• Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
• Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
• Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
• Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
• Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing.
• Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
• Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
• Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.

Qualifications:

• Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment.
• Quality Engineer II: Typically 4–5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products.
• Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
• Experience supporting early-phase (preclinical to Phase I) product development is highly desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
• Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

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

We are supporting the launch of a new robotics and automation engineering hub for a well-established global industrial technology company with approximately $400M in annual revenue.

This facility will serve as a center of excellence, combining office space with a hands-on production and integration environment for the design, assembly, and implementation of advanced robotic solutions.

This is a hands-on role responsible for overseeing day-to-day operational, facilities, and production support activities to ensure efficient and safe execution across the site.

Responsibilities:

Inventory & Supply Chain Management

• Receive and inspect incoming parts and materials for accuracy and quality
• Maintain inventory records and perform regular stock audits
• Coordinate with suppliers to resolve discrepancies and ensure timely fulfillment
• Track shipments and monitor delivery schedules

Production Coordination

• Schedule and coordinate work with assembly contractors and external vendors
• Ensure proper documentation and build instructions are provided
• Monitor production timelines and address issues that may impact delivery
• Support quality checks during and after assembly

Plant Safety & Compliance

• Implement and maintain workplace safety procedures in accordance with regulations
• Conduct routine safety inspections and address potential hazards
• Maintain safety records and documentation
• Provide safety guidance and training for employees and contractors

Facilities Management

• Oversee day-to-day maintenance of the engineering and production facility
• Coordinate minor repairs, equipment upkeep, and workspace organization
• Ensure the facility remains clean, safe, and optimized for efficient operations
• Manage external vendors for major repairs, maintenance, or upgrades

Purchasing & Vendor Management

• Source and procure parts, materials, tools, and equipment
• Obtain and compare quotes, negotiate pricing, and manage supplier relationships
• Track purchases and maintain expense records
• Maintain a database of approved suppliers and contractors

Operational & Administrative Support

• Maintain operational documentation related to inventory, production, and facilities
• Prepare reports on operational performance and recommend improvements
• Track budgets related to supplies, contractors, and facility needs
• Support onboarding and coordination of contractors or new team members

Cross-Functional Collaboration

• Partner closely with engineering, logistics, and leadership teams to support program execution
• Provide regular status updates and escalate operational risks or issues

Process Improvement

• Identify workflow inefficiencies and implement operational improvements
• Proactively resolve issues to minimize delays and disruptions

Qualifications

• Experience in operations, facilities, manufacturing, or production environments
• Strong organizational, multitasking, and problem-solving skills
• Knowledge of inventory management and supply chain processes
• Familiarity with manufacturing, assembly, or hardware environments
• Understanding of workplace safety standards and compliance
• Proficiency with tools or software for inventory tracking, scheduling, and reporting
• Strong communication skills and ability to work cross-functionally
• Hands-on, self-starter mindset comfortable in a fast-paced environment

About the Opportunity

• New robotics engineering hub located north of Boston with modern office and production lab space
• Opportunity to help build and scale operations from the ground up
• Backed by a stable, globally recognized industrial technology organization
• Strong growth plans and long-term career development potential