Engineering Structures Jobs in Reading Massachusetts
143 positions found — Page 11
Are you an experienced Field Engineer 2 Civil with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Field Engineer 2 Civil to work at their company in Burlington, MA.
Position Summary: This is a project assignment with the possibility for a temporary to permanent position in the future, though no guarantees can be made. We are seeking an experienced professional with a background in linear water rehabilitation, particularly sewers, for an onsite role in a sewer rehabilitation project for a utility client in Boston.
Primary Responsibilities/Accountabilities:
- Provide Owner's representative services and review drawings, RFIs, etc., to offer technical support to main contractors in the field.
- Coordinate with the design engineer office to determine necessary changes.
- Provide subcontractors with information and direction according to contract specifications to ensure work proceeds as scheduled.
- Interpret technical requirements and provide solutions in collaboration with the Project Department Engineer and Discipline Superintendent.
- Direct work as assigned and consistent with the company's contractual commitments.
- Perform subcontract administration of discipline-specific or assigned procurements.
- Interpret and administer fundamental commercial issues.
- Provide technical direction/interpretation of design drawings and specification requirements.
- Perform fundamental design checks and redesign in the field without supervision.
- Monitor discipline construction activities for compliance with the CPM schedule.
- Prepare and issue all discipline extra work authorization requests with the approval of the Project Field Manager.
- Maintain a daily log for site record purposes and complete quantity take-offs as required.
- Review all subcontractor progress payment requests for acceptance.
- Monitor technical service representative daily logs and review/approve their timesheets.
- Direct site document control activities for design documents.
- Assist Field Quality Assurance Manager in performing inspections and verification of tests.
- Adhere to safety and quality standards as appropriate for the level of duties and accountabilities.
- Support continuous improvement efforts and manage change associated with the implementation of improvements.
Qualifications:
- 2 to 6 years of construction management and/or design experience in similar facility construction.
- Knowledge of cost control, scheduling, engineering drawings, and other documents.
- Ability to perform material takeoffs and field estimates.
- Strong communication and organizational skills.
- Familiarity with safety regulations and discipline engineering experience.
- Supervisory skills and contract administration experience.
- Professional Engineer (PE) license preferred.
Registered Nurse Residency Career Opportunity
Encompass Health: Where Nursing Meets Heart, Home, and Healing
Looking for a nursing career rooted in purpose, close to your heart and home? At Encompass Health, you'll play a vital role in patients' recoveries-providing individualized, compassionate care that makes a lasting impact. Here, small victories add up to monumental change, and you'll thrive in an environment built on support, advanced resources, and teamwork.
For new graduates or nurses with less than one year of experience, our 9-month Nurse Residency Program offers structured guidance and added support as you begin your career in rehabilitation nursing. With extended orientation, interdisciplinary shadowing, focused education, and an evidence-based project, the program sets you up for long-term success.
Encompass Health is where nursing becomes more than a job-it's a meaningful contribution to your patients, your community, and yourself.
A Glimpse into Our World
At Encompass Health, you'll experience the difference the moment you become a part of our team. Being at Encompass Health means aligning with a rapidly growing national inpatient rehabilitation leader. We take pride in the growth opportunities we offer and how our team unites for the greater good of our patients. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For® Award, among other accolades, which is nothing short of amazing.
Starting Perks and Benefits
Our benefits are designed to support your well-being and start on day one:
- Affordable medical, dental, and vision plans for both full-time and part-time employees and their families.
- Generous paid time off that accrues over time.
- Opportunities for tuition reimbursement and continuous education.
- Company-matching 401(k) and employee stock purchase plans.
- Flexible spending and health savings accounts.
- A vibrant community of individuals passionate about the work they do!
Realize Your Vision as a New Registered Nurse
- Join a supportive RN cohort with a structured curriculum designed to build confidence, enhance your skills, provide mentorship and set you up for long-term success.
- Build meaningful relationships with patients and their families, understanding their unique needs to facilitate their recovery.
- Collaborate and communicate effectively with various departments to ensure coordinated care and provide direct patient care when needed.
- Celebrate victories and milestones achieved by our patients.
Qualifications
- Valid RN licensures as required by state regulations.
- CPR certification (ACLS preferred).
ClearBridge Technology Group is seeking a strategic, growth-oriented Director of Project Management Office (PMO) to lead and scale the PMO within our Client Solutions division. This remote-based leadership role will oversee an established team of 2 PMO Managers and approximately 40+ Project Managers, with planned growth of 50% in 2026.
The Director of PMO will be responsible for the full lifecycle of PMO leadership: governance, methodology, performance management, talent development, operational excellence, and strategic alignment with executive leadership. In addition, this leader will work closely with our largest strategic partner to drive PMO synergies, enhance execution standards, and improve overall delivery performance across organizations.
This is a highly visible strategic role suited for a proven PMO leader within a Professional Services or Consulting environment.
Key Responsibilities
PMO Strategy & Leadership
- Lead, mentor, and develop a high-performing team of ~50+Project Managers across multiple client engagements
- Define and execute a multi-year PMO growth strategy aligned to business expansion goals
- Build scalable organizational structure to support 50% growth in 2026
- Establish performance metrics, accountability frameworks, and career pathing for PMO staff
- Partner with executive leadership to align PMO delivery with business strategy and revenue goals
PMO Governance & Operational Excellence
- Design, implement, and continuously improve PMO governance frameworks
- Standardize methodologies, tools, reporting, and resource management processes
- Ensure consistent project intake, prioritization, capacity planning, and portfolio visibility
- Implement KPIs and dashboards to measure delivery health, margin performance, and client satisfaction
- Drive risk management, quality assurance, and financial oversight across all engagements
Growth & Buildout
- Lead hiring strategy, workforce planning, and onboarding for planned team expansion
- Build scalable systems and infrastructure to support rapid growth
- Evaluate and implement PMO technologies and automation where appropriate
- Develop repeatable playbooks for professional services delivery excellence
Strategic Partner Alignment
- Serve as executive liaison with ClearBridge’s largest strategic partner
- Align PMO processes, governance standards, and reporting structures across organizations
- Identify opportunities for operational synergy and improved execution
- Drive joint performance reviews, shared KPIs, and continuous improvement initiatives
- Enhance cross-organizational communication and collaboration
Client Delivery & Financial Oversight
- Ensure consistent, high-quality execution across all client engagements
- Monitor project financials, margin and utilization performance, and forecasting accuracy
- Partner with Sales and Client Solutions leadership on scoping, resource modeling, and risk evaluation
- Establish best practices for change-management and client communications
Required Qualifications
- 5–10+ years of dedicated PMO leadership experience
- Proven experience building and scaling multiple PMOs within a Professional Services or Consulting environment
- Demonstrated success leading teams of 25+ project managers in a distributed/remote environment
- Deep expertise in PMO governance, portfolio management, and delivery frameworks
- Experience managing growth initiatives and organizational transformation
- Strong financial acumen including revenue forecasting, margin management, and utilization tracking
- Experience collaborating with strategic partners or enterprise clients at an executive level
- Exceptional leadership, communication, and executive presence
Salary: $175K-$225K + bonus
The posted range is an estimate, the actual compensation offer will be based on the candidate’s experience, skills, qualifications and will be in line with internal equity.
We offer an excellent benefits package
ClearBridge is an Equal Opportunity Employer
The applicant shall ensure that all system deliverables comply with DoD and Air Force cybersecurity policy, specifically DoDI 8500.01, Cybersecurity, and that application deliverables are complaint with Public Law 111-383, which states the general need for software assurance.
Essential Job Functions: To ensure that cybersecurity policy is implemented correctly on systems, the applicant shall ensure compliance with DoD and Air Force certification and accreditation policies, specifically Department of Defense Instruction (DoDI) 8510.01, Risk Management Framework (RMF) for DoD Information Technology.
The applicant shall ensure that all application deliverables comply with DISA Application Security Development Security Technical Implementation Guide (STIG), which includes the need for source code scanning to mitigate vulnerabilities associated with SQL injections, cross-site scripting and buffer overflows.
The applicant shall support activities and meet the requirements of DoDI 8520.02, Public Key Infrastructure (PKI) and Public Key (PK) Enabling, in order to achieve standardized, PKI- supported capabilities for biometrics, digital signatures, encryption, identification and authentication.
The applicant shall be able to perform work that involves ensuring the confidentiality, integrity, and availability of systems, networks, and data through the planning, analysis, development, implementation, maintenance, and enhancement of information systems security programs, policies, procedures, and tools.
The applicant shall travel as required to support cybersecurity assessments or cybersecurity incidents.
The applicant shall ensure personnel performing cybersecurity activities obtain and remain current with technical and/or management certifications to ensure compliance as directed by DoD 8140.02, Identification, Tracking, and Reporting of Cyberspace Workforce Requirements, and outlined in DoD 8570.01-M, Department of Defense Computer Network Defense (CND) Service Provider Certification and Accreditation Program, Appendix 3, Table 1.
Responsibilities may include but are not limited to: Assist with development of System Security Management Plans, Program Protection Plans, Security Risk Analyses, OPSEC Plans, Computer Certification and Accreditation, Security Vulnerability and Countermeasures Analyses, Security Concepts of Operations, and other system security engineering-related documents identified in MIL-STD 1785, DoDI 5000.02, Operation of the Adaptive Acquisition Framework, and DoDI 8510.01.
Support the system/application Authorization and Accreditation (A&A) effort to include assessing and guiding the quality and completeness of A&A activities, tasks and resulting artifacts mandated by governing DoD and Air Force policies (i.e., Risk Management Framework (RMF).
Update, monitor, and manage information in systems for the program office.
Process and manage system user account requests and process tools.
Process and manage system port/protocol and access control list requirements.
Process and manage system Public Key Infrastructure (PKI) identification and authorization requirements.
Manage the distribution, implementation, remediation, and tracking of system security updates and configurations as required by the DoD.
Recommend policies and procedures to ensure information systems reliability and accessibility to prevent and defend against unauthorized access to systems, networks, and data.
Conduct risk and vulnerability assessments of planned and installed information systems to identify vulnerabilities, risk, and protection needs.
Promote awareness of security issues among management and ensuring sound security principles are reflected in organizations’ vision and goals.
Conduct systems security evaluations, audits and reviews.
Recommend systems security contingency plans and disaster recovery procedures.
Recommend and implementing programs to ensure that systems, network, and data users are aware of, understand, and adhere to systems security policies and procedures.
Participate in network and systems design to ensure implementation of appropriate systems security policies.
Recommend initial, or updates to, software and configurations to new or existing system security mechanisms.
Obtain waivers to mandated security mechanisms/policies which would be detrimental to system performance and impact the system’s mission.
Facilitate the gathering, analysis and preservation of evidence used in the prosecution of computer.
Provide leadership assistance in the analysis of the design, development, integration, implementation and testing of cybersecurity requirements.
Develop risk-based strategies to address identified gaps.
Review, analysize, and assess implementations of cybersecurity (i.e.
RMF security controls) throughout the open systems architecture and associated services, derived requirements specifications, design documents & design implementation.
Collaborate with stakeholders (Government and commercial) to ensure the system is approved by all Authorizing Officials via the RMF A&A process.
Provide technical advice in the area of systems security across all systems and supports.
Develop recommendations for the Government regarding how well designs satisfy current requirements and business goals.
Maintain databases that reflect receipt, storage, inventory, and disposition of classified information to include data entry, updates, and generation of reports.
Support Government program office in audits of Government classified holdings to ensure proper accountability.
Maintain databases of classified visits and clearance levels.
Perform inspection, inventory, logging, storage, documentation, transmittal and internal distribution of classified information received.
Evaluate applicant classified data submittals for compliance with the appropriate System Security Classification Guide (SSCG).
Provide security inspection and protection to areas where classified information is being stored, and develop and establish security procedures and policies IAW DOD, USAF, AFMC, and local directives.
Required Skills: Due to the sensitivity of customer related requirements, U.S.
Citizenship is required.
A High School Diploma plus 20 years of experience, an Associate plus 14 years, a bachelor's degree plus 512years or a master's degree plus 10 years of experience.
An adjudicated DoD Secret Security clearance on the First Day of employment.
CISSP Certification required.
Understanding of cybersecurity in DoD cloud infrastructure.
Understanding of Agile methods, including CI/CD, DevSecOps, and DevOps.
Possess the ability to effectively communicate in both written and verbal forms on highly technical topics.
Salary Range: $87,934-$120,000 At DCS, we pride ourselves on providing flexibility that allows employees to balance meaningful work with their personal lives.
We offer competitive compensation, benefits, and opportunities for learning and development.
Our broad and competitive mix of benefits is designed to support and protect employees and their families.
Our robust benefit offerings include medical, dental, 401k, ESOP, PTO, education reimbursement, work/life balance, parental and other leave programs.
Learn more about our benefits here: DCS Corp Benefits
Kessel Run is an Air Force unit that delivers resilient command and control and targeting software capabilities that provide warfighters with decision advantage.
Under the Department of the Air Force Program Executive Office for Command, Control, Communication, and Battle Management (DAF PEO C3BM), Kessel Run technologies make up the DAF BATTLE NETWORK, the systems-of-systems designed to help the Joint Force make operational decisions faster than our adversaries.
The Division architects and acquires the means to connect weapon systems with warfighters and decision makers to enable the warfighter to win against the pacing challenge in an era of great power competition.
This is a full time position located at Hanscom AFB, Bedford, MA.
Essential Job Functions: Perform routine cost estimating methods such as analogy, engineering or scientific methodology, and extrapolation.
Perform cost estimating outputs to assess the impact various factors have on the costs to design, research, develop, operate, maintain, and dispose of a particular weapon system.
Analyze all elements affecting costs for a project of limited scope.
Analyze contractor financial data using Earned Value Management (EVM) measures of merit to determine program viability with respect cost and schedule performance.
Analytical processes, such as: setting up the problem; conducting background research; collecting and reducing data; displaying data for analysis; formulating mathematical expressions; and drawing conclusions.
Provide contract pricing support services for tasks in all phases of the acquisition cycle to include development, award, management, measurement and contract closeout.
Prepare draft pricing briefings, draft pricing correspondence, and draft agency pricing reports.
Develop pricing related evaluation criteria, track pre-award task order milestones and status.
Support source selection teams in the evaluation of cost proposals.
Prepare pricing documentation for review and approval by the Government CO.
Prepare pricing spreadsheets of technical proposals and perform other pricing analyses to support price/cost evaluations of technical.
proposals.
Required Skills: Due to the sensitivity of customer related requirements, U.S.
Citizenship is required.
Must have an Active Secret Clearance.
BS/BA Degree in a related discipline 5 years of experience with experience in related discipline.
Knowledge of most appropriate phase of the budgetary cycle (planning, programming, justification, and execution) for initiating new programs.
Experience in quantitative analysis and calculus.
Experience with ACEIT.
Salary Range: $58,935-$75,000 At DCS, we pride ourselves on providing flexibility that allows employees to balance meaningful work with their personal lives.
We offer competitive compensation, benefits, and opportunities for learning and development.
Our broad and competitive mix of benefits is designed to support and protect employees and their families.
Our robust benefit offerings include medical, dental, 401k, ESOP, PTO, education reimbursement, work/life balance, parental and other leave programs.
Learn more about our benefits here: DCS Corp Benefits
Job description:
Flagship Facility Services is seeking an experienced Building Engineer to support building operations and maintenance at a Life Science site based in Lexington, MA. This role is ideal for a skilled facilities professional with strong technical expertise who thrives in a fast-paced, mission-critical environment. Candidate MUST hold active waste water license and boiler operator licenses.
What We Offer
- Competitive pay
- Medical, Dental, and Vision Insurance
- Paid Time Off (PTO)
- 401(k) Retirement Plan
- Opportunities for growth and advancement within Flagship Facility Services
What You’ll Do
- Perform advanced maintenance, troubleshooting, and repair of building systems including HVAC, electrical, plumbing, and mechanical systems
- Operate, maintain, and monitor critical facility equipment to ensure reliable and safe operations
- Respond to and resolve work orders, service requests, and emergency situations in a timely manner
- Perform preventive and predictive maintenance to maximize equipment uptime
- Coordinate with vendors and contractors for specialized repairs and services
- Maintain accurate documentation, logs, and reports related to facility operations
- Support compliance with safety standards, company policies, and regulatory requirements
- Provide guidance and support to junior technicians as needed
What We’re Looking For
- 5+ years of experience in facilities maintenance or engineering (life sciences environments preferred)
- active waste water license and boiler operator licenses.
- Strong working knowledge of HVAC, electrical, plumbing, and mechanical systems
- Ability to read and interpret blueprints, schematics, and technical documentation
- Excellent troubleshooting and problem-solving skills
- Strong communication skills and customer-service mindset
- Ability to work independently and as part of a team
- EPA Universal Certification or other relevant certifications preferred
Schedule
- Full-time position
- Schedule may include on-call or off-hours support as required
About Flagship Facility Services
Flagship Facility Services is a leading integrated facilities management company, providing world-class support services to a wide range of industries. We pride ourselves on innovation, operational excellence, and investing in our people.
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.
Senior Validation Engineer
Site & Equipment Qualification
Radiopharmaceutical Manufacturing
Location: Wilmington, MA
Must have Green Card or Citizenship
Join my client’s cutting-edge radiopharmaceutical manufacturing operation and play a pivotal role in bringing life-changing therapies to patients. As the Senior Validation Engineer, you’ll lead site startup, facility qualification, and GMP equipment validation in a highly specialized, radiation-controlled environment. This is your opportunity to shape compliant, inspection-ready systems from the ground up in a rapidly advancing sector of biotech.
Why You Should Apply
- High-impact role supporting innovative radiopharmaceutical production
- Lead site startup and expansion initiatives in a regulated GMP setting
- Work with advanced systems: hot cells, isolators, synthesis modules
- Competitive salary range: $120,000 – $185,000 Depending on level and experience
- Comprehensive benefits package including medical, 401(k), and PTO
What You’ll Be Doing
- Lead facility, utility, and cleanroom (ISO) qualification activities
- Develop and execute Validation Master Plans (VMP)
- Author and execute URS, DQ, IQ, OQ, PQ protocols
- Oversee qualification of HVAC, WFI, clean steam, gases, and water systems
- Support FAT/SAT, manage deviations, CAPAs, and change controls
- Serve as SME during FDA and regulatory inspections
About You
- Bachelor’s degree in Engineering or related technical field
- Strong expertise in GMP commissioning & qualification lifecycle (ASTM E2500 preferred)
- Hands-on experience in aseptic manufacturing environments
- Experience with radiopharma systems (hot cells, shielded isolators, synthesis modules)
- Deep knowledge of 21 CFR 210/211 and radiation safety regulations
How To Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19738.
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
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
