Engineering Structures Impact Factor Jobs in Lawrence New Jersey

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- Develop career skills
- Flexible schedule We're hiring substitute paraprofessionals for a top education client to fill immediate openings across Philadelphia and Bucks County.

Accepting applications from both certified substitute paraprofessionals and those with no teaching experience.

Our hiring coordinators are ready to help you through the entire application and onboarding process.

Job Description: A substitute paraprofessional assists the classroom teacher to provide extra support to students with special needs, promoting maximum academic and personal growth.

The substitute paraprofessional job responsibilities range from supplementing regular classroom curriculum to helping individual students.

Substitute paraprofessionals are also known as school aides, teacher assistants, instructional aides, one-to-one aides, and personal care assistants.

Responsibilities: Provide instructional reinforcement for individual students or small groups of students Assist teacher with classroom management and general supervision of the class Assist with administrative duties such as setting up equipment and preparing materials Supervise students in the cafeteria, schoolyard, specials, hallways, on field trips, and/or during before and after school programs Attend to students' physical, personal, academic, and emotional needs Support students with special needs by following provisions specified in their IEPs/504 Plans Perform other duties as directed by the classroom teacher and school administration Qualifications: High School Diploma or GED Proficient in English (speaking, reading, writing) Pay: $15.00/hr

Essential Functions of the job:

• Review and validate QC data and test records.
• Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
• Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
• Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
• Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
• Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Strong working knowledge with USP/EP and cGMP/EU GMP.
• Technical writing experience.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development
• Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

FIELD SALES AND MARKETING REPRESENTATIVE – Techtronic Industries, NA (TTI)

About Us:

TTI (Techtronic Industries) is a fast-paced, high energy, organization that rewards out-of-the-box thinking to foster innovation allowing us to be the best in our industry. We provide a multi-faceted training program and hands-on field experience that will stimulate, challenge, and reward you.

TTI is a world-class leader in design, manufacturing and marketing of power tools and accessories, outdoor product equipment, and floor care products. Our consumers range from professional and industrial users in the home improvement, repair, and construction industries to homeowners & DIY enthusiasts. Our unrelenting strategic focus on powerful brands, innovative products, operational excellence, and exceptional people drives our culture. This focus and drive provides TTI with a powerful platform for sustainable leadership and strong growth.

Our brands and products are recognized worldwide for their deep heritage, superior quality, outstanding performance, and compelling innovation. Our products include professional power tools and accessories, outdoor power equipment, and floor care. Our brands include Milwaukee®, AEG®, Ryobi®, Hart ®, Oreck®, Hoover®, Dirt Devil® and Vax®.

In this position, you will drive sales of our premier product lines within one of our largest retail partners. This position will allow you to enhance your selling, account management, and communication skills while launching your career in a fast-paced and extremely rewarding company.

Duties and Responsibilities:

• Exceed sales targets by delivering best-in-class Business to Consumer sales and customer service within The Home Depot, engaging directly with customers to understand their needs and recommend tailored TTI product solutions, all while demonstrating deep product knowledge and enthusiasm
• Plan and execute promotional events, product demos, and store walks to drive consumer engagement and increase product sell-through
• Support and implement strategic corporate brand marketing initiatives and promotional activities to increase brand awareness and drive sell-through
• Ensure brand presence and sales-readiness through strategic merchandising, optimal product placement, and completion of store objectives and resets—leveraging data analytics through Microsoft Power BI to drive decisions and maximize impact
• Develop a strong understanding of the retail marketplace, including customer profiles, product applications, competitive landscape, and channel dynamics
• Participate in TTI’s world class training program to be equipped with the knowledge to work independently within your assigned market
• Build and manage relationships with The Home Depot team members to enhance in-store execution and cultivate long-term business partnerships
• Effectively manage inventory levels through down-stocking, maintaining product accessibility, and ensure prompt reporting of all tasks and responsibilities
• Participate in merchandising resets to support TTI’s relentless innovation, ensuring the timely placement of cutting-edge products and solutions that drive growth, competitive advantage, and meet evolving market needs, all while adhering to TTI’s safety protocols

Note: Employee's duties and responsibilities are not limited by the above. Other duties may be assigned as deemed necessary by the employee's supervisor. In addition to the basic requirements of the position, all employees are expected to meet the company's goals of continual improvement in the areas of knowledge, skills, processes, and quality.

Job / Employment Requirements:

• Must be at least 21 years of age or older
• Eligible to work in the United States without sponsorship or restrictions
• Ability to pass drug screening and Motor Vehicle Report screening
• Must have a valid United States driver’s license for at least one continuous full year in one state
• Must have a personal vehicle / reliable form of transportation
• Possess and maintain valid personal vehicle insurance listing you as the primary driver
• Position requires travel to/ from assigned store location(s) as well as occasional travel for meetings, projects, events, etc. Air travel will be required
• Employees will also be required to transport a small amount of company property (company devices, demo tools, tool kit, safety supplies)
• Capable of reaching and/or lifting overhead in addition to ascending/descending ladders to move product
• Capable of lifting and transporting heavy tools (up to 50 lbs.) and requesting assistance as needed
• Capable of using hands to maneuver small objects, assemble tools and build displays
• Ability to work nights and weekends – weekends will be required at different points throughout the year
• Ability to work in a retail environment full time and stand for the duration of the shift, with the exception of meal and rest breaks
• Applicant should be self-motivated and a team player with strong organizational, planning and time management skills
• The applicant must be MS Office proficient
• Multilingual abilities preferred in specific markets depending on business needs
• Formal higher education preferred but not required – Equivalent experience will be considered
• Relocation may be required for future promotional opportunities

Compensation and Benefits:

• Salary Non-Exempt Position (Overtime Eligible)
• The pay range for this position is $24.04 and $25.96/hour equating to a Target Annual Salary of $50,000 - $54,000
• Sales Contests and Incentives to Earn Additional Income (In Correlation with Business Needs / Focuses)
• Vehicle Allowance of $400/month equating to a target of $4800/year (pre-taxed) dispersed evenly across the 52 weeks in a year
• Company iPhone and iPad
• Medical, Vision, and Dental Benefits Available
• Insurance Coverages Available such as Short-Term Disability, Long Term Disability, Basic Life Insurance, Basic AD&D, and more
• 401K (Company Matches 50% up to 8% of Employee’s Salary)
• Eligible for up to 10 Paid Holidays (Based on hire date)
• Accrue up to 104 hours of PTO – 1st Year – Based on hire date
• Relocation assistance if moving for the position based on needs of the business
• Employee Referral Bonus Program and other incentive initiatives

Locations available Nationwide. To learn more about TTI, visit our website at

Where Precision Medicine Meets Patient Care

At United Theranostics, we're not just running clinical trials — we're building the future of theranostics from the ground up. We're looking for a seasoned Oncology Research Nurse to join our Princeton, NJ team and take a central role in our growing clinical research program. This is a rare opportunity to do meaningful early-phase work at a mission-driven organization where your expertise will be felt every single day.

The Role

You'll be a key clinical partner to our physicians, research team, and referring providers — someone who brings both deep oncology knowledge and the interpersonal skill to keep complex, multi-stakeholder research running smoothly. From First-in-Human studies to ongoing safety monitoring, you'll help set the standard for how great clinical research looks at United Theranostics.

What You'll Do

• Support and oversee oncology research activities with a focus on early phase and First-in-Human studies
• Coordinate patient visits, assessments, safety monitoring, and research documentation
• Work closely with investigators, clinical staff, and referring providers to ensure clear communication and timely updates
• Reinforce and grow strong relationships with external partners and referring clinics
• Maintain protocol adherence, accurate data collection, and inspection-ready documentation
• Serve as a clinical resource and role model for the broader research team

What You Bring

• 10+ years of experience as a lead oncology research nurse
• Direct, hands-on experience with First-in-Human studies
• Strong clinical judgment and deep familiarity with early phase trial requirements
• Excellent communication skills and a reputation for follow-through
• A genuinely collaborative approach and the ability to work across disciplines
• Active RN license in good standing

Why This Role

Your work here will have direct, visible impact — on our research program, on our referring provider relationships, and on the patients who trust us with their care. You won't be a number on a roster. You'll be a cornerstone of what we're building.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

Company Description

JDC Energy Services, LLC (JDC), an affiliate of DCO Energy, LLC, and Joseph Jingoli and Son, Inc., is a leading energy engineering, procurement, and construction (EPC) firm. JDC specializes in self-funding energy efficiency projects for public and private clients through energy savings and comprehensive incentive programs. With expertise in demand-side energy management, supply-side optimization, and construction management, JDC provides cost-effective, energy-efficient upgrades to HVAC and lighting systems. Serving a diverse range of clients, JDC works with commercial, public, K-12, healthcare, higher education, manufacturing, gaming, industrial, and pharmaceutical entities to deliver measurable value and operational savings.

Role Description

This is a full-time hybrid role for an Energy Engineer II based between our Melville, New York and Lawrenceville, New Jersey offices with flexibility to work from home one day per week.

The Energy Engineer plays a key role in developing innovative energy conservation measures and demand‑side management strategies for buildings and facilities. Working closely with facility managers, this role conducts detailed energy assessments, performs on‑site investigations, and evaluates the performance of building systems.

The Energy Engineer prepares energy‑savings calculations, drafts clear and technically sound reports, and interprets engineering documents to support project planning and execution. They also monitor and support construction activities related to energy systems and equipment to ensure alignment with project specifications and industry standards.

In addition, the Energy Engineer provides technical expertise throughout project design and implementation to optimize system performance and achieve measurable energy and cost savings. The role also supports the Business Development team by evaluating potential opportunities and contributing technical insights during early‑stage project development

Responsibilities

• Performs technical energy audits and ECM payback calculations; drafts technical reports on findings.
• Provides engineering and technical support for project development and implementation and coordinates with facility personnel to optimize the operations and energy use of energy systems and equipment.
• Analyzes systems and equipment to determine optimum operating conditions and diagnose issues impacting energy consumption; develops and recommends strategies to maximize operating efficiency.
• Reviews data from Energy Management and Information Systems (EMIS), such as a building automation system, and utility billing and meter data to identify opportunities for energy and operational savings.
• Works with facility managers to implement effective and innovative energy conservation measures (ECMs) and demand-side management strategies in buildings and facilities.
• Researches, tests, and summarizes benefits of energy efficiency and renewable energy project concepts.
• Develops and delivers training on heating, ventilation, and air-conditioning (HVAC) controls and energy management for appropriate stakeholders.
• Advises on equipment specifications, conducts bidding process with equipment suppliers for upgrades and energy retrofits, and supports annual energy budget preparation.
• Reviews, monitors, and manages construction activities related to energy systems and equipment.
• Provides energy database support, including tracking and reporting of ECM and providing facility operational and use characteristics.
• Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining professional networks, and participating in professional organizations.

Skills and Experience

• Knowledge of engineering practices and principles and experience in one or more of the following engineering fields: mechanical, environmental, civil, and electrical.
• Experience with building systems and equipment, including implementing energy efficiency measures and optimizing equipment use and scheduling to maximize energy and cost savings.
• Experience making routine determinations related to engineering principles and standards and offering recommendations for nonroutine matters.
• Experience interpreting engineering documents, evaluating construction plans, and using data from EMIS to monitor and control mechanical systems.
• Ability to perform technical analysis.
• Ability to verbally communicate technical and nontechnical information to various stakeholders.
• Familiarity with ASHRAE standards.
• Ability to manage time independently and meet schedules and deadlines.
• Ability to identify high-impact energy conservation measures and manager energy efficiency projects.

• Bachelor's degree in an applicable energy or engineering field, or other relevant degree from an accredited institution.

Engineer II – Mid Level (2–5 years)

• Demonstrated experience independently executing major portions of energy projects, including leading site assessments, performing energy and cost‑savings calculations, and managing technical deliverables. Capable of coordinating with facility staff, overseeing implementation tasks, and contributing to project planning and design.

Engineer III – Senior Level (5+ years)

• Extensive experience leading full‑cycle energy projects, from opportunity development through implementation and verification. Proven ability to manage client relationships, oversee multidisciplinary teams, develop advanced energy strategies, and ensure successful delivery of complex ECMs and system upgrades.

Take Your Environmental Career to the Next Level

Kleinfelder, a Forbes' Top Employer for Engineers in North America, is committed to a people-first culture, technical excellence, and creating opportunities where employees can thrive!

Are you ready to be challenged, make a difference, and experience professional growth in your career? Kleinfelder's Environmental team is looking for you! From environmental planning, permitting, remediation, and site characterization to chemical data management and hydrogeology, Kleinfelder offers a variety of services designed to provide technically appropriate and cost-effective solutions.

Step into Your New Role

As a Senior Civil / Environmental Engineer, you will work with our civil/environmental team performing technical evaluations, planning, design, and construction administration. This role will help lead, inspire, and support our civil and environmental disciplines, and most importantly help grow our portfolio of work with clients across multiple geographies, but primarily based in New Jersey.

This position is remote and will require approximately 40% travel to project sites primarily in New Jersey and other sites across the country.

Responsibilities:

• Strong experience with the design and construction of civil and/or environmental remediation projects.
• Leading technical efforts for planning, studies, budgeting, project cost estimating, technical management, coordination of multi-disciplinary engineering efforts, quality assurance, subcontract management and contract administration.
• Supervising staff and subcontractors to successfully deliver technical projects and build/mentor staff in the group.
• Ability to effectively communicate design concepts to clients, participating in project scoping activities and proposal presentations, and coordinating with clients to ensure an ongoing positive relationship.
• Establishing strong, productive internal collaborative relationships with senior management.

Qualifications:

• B.S. in civil, environmental, or chemical engineering.
• 12 + years of experience providing technical management of civil / environmental projects.
• Professional Engineering license with ability to obtain New Jersey license within 6 months of start date, if necessary.
• In-depth knowledge of large/complex civil/environmental projects and experience coordinating the various engineering disciplines for successful project completion.
• A strong work ethic with excellent organizational, communication, computer and technical writing skills.
• Strong team building and communications skills.
• Solid written and verbal fluency in English.
• Willingness to travel out of state.
• AutoCAD and Civil 3D experience preferred.

Move Forward with Kleinfelder

Kleinfelder has been connecting great people to the best work since 1961. We are engineers, scientists, and construction professionals providing solutions that improve our clients' transportation, water, energy, and other private infrastructure. As a responsive, cross-disciplinary team of bright, curious, and innovative problem-solvers, we are dedicated to doing the right thing, every day, on every project from over 85 offices in the US, Canada, and Australia. Connecting great people to the best work is our purpose - together, we deliver.

Progress with an Employer that Values You

Kleinfelder is an inclusive organization free from discrimination. We are a stronger organization when we are a diverse workforce and believe that throughdiversity, equity, and inclusion comes creativity, innovation, and unity. We are proud to offer the following:

Benefits: Kleinfelder offers an excellent compensation and benefits package, including medical, dental, vision, life insurance, 401(k) plan, and paid holidays.

New Jersey: The expected salary range for the position is displayed in accordance with the New Jersey Wage Transparency Law. Final agreed upon compensation is based upon individual qualifications and experience. Salary range: $131,000-$182,000.

Career Development: We are committed to investing in the professional development of our staff, offering each employee every opportunity to grow, develop, and take control of their career paths. We support these efforts through reimbursements for continuing education as well as many of the expenses associated with trainings and certifications, and opportunities for career development through our internal Mentoring Program.

Equal Opportunity: Kleinfelder is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans. (Compliant with the new VEVRAA and Section 503 rules)

NOTICE TO THIRD PARTY AGENCIES

Please note that Kleinfelder does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Fee Agreement, Kleinfelder will not consider or agree to payment for any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Kleinfelder explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resume, including those submitted to hiring managers, are deemed to be the property of Kleinfelder.

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions.

Key Responsibilities

Inspection Readiness & Regulatory Compliance

• Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing.

• Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits.

• Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies.

• Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices.

Regulatory Inspections, Client Audits & Customer Assessments

• Serve as the front-room inspection lead for regulatory authority inspections and client audits.

• Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching.

• Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates.

• Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency.

Quality Systems Interface & Continuous Improvement

• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance.

• Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement.

• Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches.

Leadership, Influence & Collaboration

• Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence.

• Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives.

• Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status.

• Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.

• 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations.

• Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW).

• Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements.

• Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution.

• Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership.

• Experience leading audit and inspection planning, execution, and response activities.

• Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed.

• Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset.

Preferred Qualifications

• Experience supporting multiple clients simultaneously within a CDMO.

• Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections.

• Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions.

• Lean, Six Sigma, or quality excellence certifications.

Educational Requirement

• B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred.

Physical Requirements

• Ability to perform essential job functions in compliance with company standards, including productivity and attendance.

• Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms.

• Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals.

• Must be flexible and adaptable to changing priorities and dynamic environments.

Global Product Quality Specialist

12-month Contract

Remote- EST Hours

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.

Java / Software Developer Opportunity @ BeaconFire

Location: East Windsor New Jersey

Visa Sponsorship Available | E-Verified Company

Kickstart Your Career with BeaconFire!

Are you passionate about coding and looking to grow your career in Software Development?

BeaconFire, based in Central NJ, is a leader in Software Development, Web Development, and Business Intelligence. We're on the lookout for dynamic individuals with a strong background in Software Engineering or Computer Science to join our team as Java / Software Developers!

What You'll Be Doing:

• Develop applications using Java 8/JEE (and higher), Angular 2+, React.js, SQL, Spring, HTML5, CSS, JavaScript, TypeScript, and more.
• Write scalable, secure, and maintainable code for high-impact client platforms.
• Create, deploy, and maintain automated system tests.
• Collaborate with testers to understand and resolve defects efficiently.
• Investigate new technologies and tools for continuous improvement and architecture reviews.
• Work closely with team members to achieve shared user story and sprint goals.

What We're Looking For:

• Experience in Java and JavaScript programming languages.
• A good understanding of the Software Development Life Cycle (SDLC).
• Strong object-oriented programming (OOP) skills and knowledge of Collections, Maps, Lists, Sets, and common APIs.
• Familiarity with relational databases like SQL Server or Oracle and basic SQL queries.

Preferred Qualifications:

• Master's Degree in Computer Science (CS).
• 0–1 year of hands-on experience in Java coding.
• Experience with Spring, Maven, Angular, HTML, and CSS.
• Knowledge of modern Java technologies like WebLogic, RabbitMQ, Tomcat.
• Familiarity with JSP, J2EE, and JDBC.

Why Join BeaconFire?

• E-Verified Employer
• Visa Sponsorship Provided
• Opportunities to work on cutting-edge tech
• Collaborative and growth-focused work culture

Apply Today and Build Your Future with BeaconFire!

Let's turn your passion into a profession!