Engineering Jobs in None, NJ

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

The Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates crossfunctionally to support timely resolution of product issues and support corrective and preventive actions.

Job Responsibilities and Essential Duties

• 
  
• Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
  
• Initiate, own and support Corrective and/or Preventive Actions
  
• Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
  
• This is not an inclusive list of job responsibilities
  

Required Knowledge, Skills and Abilities

• 
  
• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
  
• Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
  
• General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
  
• Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
  
• Experienced with handling Biohazard materials.
  

• 
  
• Experience with laboratory work in the medical devices industry.
  
• Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
  
• Excellent written and verbal communication skills.
  
• Strong problem-solving skills and a passion for investigation and root cause analysis
  
• Strong interpersonal skills.
  
• Good organizational skills. Must be able to adhere to timelines.
  
• Basic understanding of statistical analysis.
  
• Basic understanding of quality systems
  

The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 8% Annual Bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

To support CS Manufacturing and support the manufacturing engineering department.

Job Responsibilities and Essential Duties

• 
  
• Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
  
• Participates in Material Review Boards (MRB) Decision process.
  
• Identifies and implements corrective actions for manufacturing related issues.
  
• Performs equipment setup and corrective, preventative and calibration maintenance as necessary.
  
• Installs and validates equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
  
• Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
  
• Certifies manufacturing associates in the production processes.
  
• Evaluates and orders necessary equipment, tools, and fixtures.
  

Minimum Requirements

• 
  
• A high school diploma or equivalent is required. Associate Degree in Engineering, Science or related technical field is preferred.
  
• One to three years of technician experience in a manufacturing environment is required; Experience working in medical device manufacturing or other FDA regulated industry would be ideal.
  

Required Knowledge, Skills, and Abilities

• 
  
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  
• Must demonstrate effective verbal and written communication skills.
  
• Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities. Must be flexible and demonstrate the ability to take initiative.
  
• Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
  

The compensation range for this position is between $26-$31 per hour depending on experience and location.

#LI-MV1

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 
  
• Health, Dental, and Vision insurance benefits
  
• 401k plan with company match
  
• Paid Time Off
  
• Wellness initiative & Health Assistance Resources
  
• Life Insurance
  
• Short and Long Term Disability Benefits
  
• Health and Dependent Care Flexible Spending Accounts
  
• Commuter Benefits
  
• Parental and Caregiver Leave
  
• Tuition Reimbursement
  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Why You'll Love Working at Avantor

At Avantor, you're not just joining a finance team-you're stepping into a missiondriven organization where your insights and leadership truly matter. As a Sr. Accountant, you will:

Make a Visible Impact

Your work directly influences financial accuracy, operational excellence, and strategic business decisions across a global enterprise.

Grow Your Career with Intention

Elevate your technical accounting skills, deepen your SOX expertise, or expand into leadership-Avantor supports professional growth at every stage.

Lead Through Influence

Collaborate closely with Engineering, FP&A, and crossfunctional partners. Your coaching, mentorship, and process ownership will improve team performance and strengthen our financial operations.

Thrive in an Inclusive, Collaborative Culture

We value cultural confidence and competence. You'll work with diverse teams that welcome diverse perspectives and promote a sense of belonging.

Leverage Modern Tools & Systems

Your SAP and ERP experience will be put to strategic use as you participate in process enhancements, system optimization, and internal control strengthening.

Drive Process Improvements

Bring your ideas, identify gaps, and implement workflows that elevate operational efficiency and accuracy.

Competitive Salary & Stability

This role offers a competitive salary up to $110,000 and the stability of a global, established, and growthoriented organization.

Built for EST Candidates

Ideal for candidates located in NY, NJ, or PA, where collaboration aligns seamlessly with business needs and time zone requirements.

What We're Looking For

To attract the most qualified talent, we emphasize these key criteria:

Required Competencies

• Willing to work in the Eastern Time Zone (preferably based in NY, NJ, PA)

• Culturally confident and culturally competent communicator

• Strong SAP and ERP system experience

• Experience in team leadership, coaching, and mentoring

• Proven process implementation and continuous improvement mindset

• High accountability and ownership of work quality

• SOX control experience

• Fixed asset accounting expertise

• Salary requirement: up to $110,000 maximum

Role Overview

Under general supervision, the Sr. Accountant will collaborate with partners across the organization to:

• Provide detailed reports, including profit/loss projections

• Present financial reports and insights to internal leaders

• Analyze financial data and propose solutions to accounting issues

• Investigate and provide feedback on irregularities

• Support monthend, quarterend, and yearend closing processes

• Ensure SOX compliance and support remediation efforts

• Assist internal and external audit processes

• Manage fixed asset accounting including acquisition, classification, depreciation, and disposal

• Partner with Engineering on capital project accounting (budgets, AUC tracking, requests, capitalization)

• Prepare journal entries, reconciliations, roll forwards, and variance analysis

• Conduct balance sheet reconciliations and validate subsystem accuracy

• Support tax filings (sales/use tax)

• Participate in process improvement initiatives to enhance accuracy & efficiency

• Validate accuracy of work product and uphold quality standards

Who You Are

You demonstrate a balance of technical depth, operational awareness, and the ability to collaborate across diverse teams. You also bring:

• Bachelor's degree in accounting or related field

• 3-6+ years of relevant experience

• Strong ERP experience (SAP preferred)

• Intermediate-Advanced Excel skills (VLOOKUPs, pivot tables)

• Solid GAAP knowledge and internal controls understanding

• Strong organizational skills and exceptional followup

• Proactive problemsolver with continuous improvement orientation

• Ability to multitask and prioritize effectively

• High degree of discretion, professionalism, and critical thinking

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.

Responsibilities:

• Draft electrical, software, computer, business method, and mechanical patent applications.
• Draft responses to patent application office actions.
• Research and prepare opinions related to patentability, patent validity, freedom to operate and infringement.
• Docketing via DocketTrak docketing system.

·        Electronic filing of IP cases via the USPTO’s EFS-WEB online filing system.

·        Preparation of patent filings.

·        Preparation and transmission of form cover letters.

• Assist with IP-related agreements and transactions.
• Assist in other legal matters as needed.

Qualifications/Requirements:

• A technical degree, preferably in electrical engineering, computer science, or an equivalent degree.
• Strong written and oral communication skills.
• A strong attention to detail.
• Ability to quickly identify and prioritize issues.
• Knowledge and command of U.S. Patent Office procedures.
• Experience with DocketTrak docketing software preferred but not required.
• Experience with EFS-WEB online filing system preferred.
• One – three years patent attorney experience but willing to train the right candidate; including 3rd year law students with immediate availability.
• DETAIL-ORIENTED.
• Strong organizational skills.
• Strong computer skills including Microsoft Word, Excel, and Outlook required.
• Experience with USPTO online filing systems a requirement.
• A college degree and juris doctorate required.

If you would like to apply for this position please forward the following information to for immediate consideration:

• Resume
• Salary requirements

NO PHONE CALLS OR FAXES.

Our employer is a leading provider of premium metal payment cards and secure authentication solutions. Headquartered in Somerset, New Jersey, the company serves major financial institutions, producing over 30 million metal cards annually and holding a dominant share in the premium metal card segment. It also offers advanced digital security through a proprietary platform that includes three-factor authentication and cold storage for digital assets, generating over $420 million in annual sales.

• Salary range: 85-150k USD
• Annual Bonus: Up to 15% (contingent upon a combination of company's and personal performance).

Position Summary

We are seeking an Advanced Manufacturing Engineer (Automation) who will perform the planning, design, and implementation of automation solutions across our production lines. This role involves designing and building custom machines in-house as well as managing external integrators to deliver turnkey automation systems. The ideal candidate will have a proven track record in machine design, supplier management, and project execution in high-volume manufacturing environments.

This position is critical to driving automation initiatives that improve efficiency, scalability, and quality in a multi-million-unit-per-year production setting.

Key Responsibilities

• Automation System Design & Implementation
• Design and develop custom automation equipment using SolidWorks.
• Lead full lifecycle of automation projects: concept, design, build, installation, and validation.
• Collaborate with external integrators and manage suppliers for outsourced machine builds.
• Production Line Automation
• Plan and implement automation solutions for assembly and packaging lines.
• Integrate robotics, PLCs, vision systems, and material handling equipment.
• Project Management
• Develop project timelines, budgets, and resource plans.
• Ensure projects meet performance, quality, and safety standards.
• Safety & Compliance
• Ensure all automation systems comply with OSHA, environmental, and company safety standards.
• Implement risk assessments, machine guarding, and lockout/tagout procedures.
• Maintain documentation for regulatory compliance and audits.
• Continuous Improvement
• Identify automation opportunities to reduce labor, improve throughput, and enhance quality.
• Drive cost reduction and efficiency initiatives through innovative automation solutions.

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.

Experience

• 5+ years of hands-on experience in machine design and automation engineering.
• Proven track record of designing, building, and installing machines in high-volume manufacturing environments.

Technical Expertise

• SolidWorks proficiency for machine and fixture design.
• Strong knowledge of automation technologies: robotics, PLC programming, vision systems, conveyors, and material handling.
• Experience with supplier management and working with external integrators.
• Understanding of system design, defect analysis, and process optimization.
• Familiarity with SPC, Six Sigma, and DoE methodologies for data-driven improvements.
• Ability to troubleshoot automation and mechanical issues, conduct root cause analysis, and implement corrective actions.

Preferred

• Experience designing full production lines.
• Familiarity with high-speed automation for multi-million-unit production.
• Knowledge of Lean Manufacturing principles.
• Exposure to ISO 13485 or automotive quality standards.
• Experience with robotic integration, automated quality inspection, and vision systems.

Our employer believes in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:

• Medical, Dental & Vision Coverage
• Flexible Spending Accounts (FSA)
• Company-Paid Life and Disability Insurance
• 401(k) with Company Match
• Paid Time Off & Paid Holidays
• Annual Bonus Opportunities
• Employee Assistance Program (EAP)
• Career Advancement Opportunities

**** Benefits eligibility and details will be shared during the hiring process.

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 Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

About the Company:

At Lincoln Electric Products Co. Inc., We Specialize In The Design, Manufacture, And Distribution Of Custom Equipment Tailored To Meet The Specific Applications And Requirements Of Our Customers. Our Product Range Includes:

• Panelboards: Up to 2000A
• Service and Distribution Switchboards: Up to 8000A
• Generator Connection Boxes
• Generator Output Switchboards
• Single and Double-Ended Substations
• We pride ourselves on delivering high-quality, custom-designed solutions that address the unique needs of our clients across various industries.

Position Summary

Lincoln Electric Products Co. Inc. is seeking a highly motivated and experienced Assembly Manager to join our team in Union, NJ. This individual will play a critical role in overseeing the daily operations of the assembly department, driving efficiency, and ensuring the seamless execution of organizational goals. The Assembly Manager will work collaboratively across departments to enhance productivity, implement process improvements, and contribute to the overall success of the business.

While this role primarily operates Monday through Friday, occasional Saturday work may be required based on business demands. This full-time, exempt position reports directly to the Director of Operations and involves a hands-on approach.

Working Conditions: Office/Shop Environment

Primary Job Function:

• The Low-Voltage Switchboard Assembly Manager oversees the factory's production (including EV) and assembly of low-voltage switchgear systems.
• This includes managing operations and personnel involved in the assembly process to ensure efficient production, high-quality output, and timely delivery.
• The role demands strong leadership, operational expertise, and a focus on continuous improvement in a unionized manufacturing environment.

Key Job Responsibilities:

• Production Planning: The Assembly Manager is responsible for developing production plans, scheduling work activities, and ensuring the availability of necessary resources, such as materials, tools, and equipment, to meet production targets.
• Quality Control: They are responsible for implementing quality control measures and ensuring that all assembled switchgear systems meet the required standards and specifications. This includes conducting regular inspections, tests, and audits to identify and address any quality issues.
• Process Improvement: The Assembly Manager continually looks for opportunities to improve the assembly process, optimize workflow, and enhance productivity. They may collaborate with engineering teams to implement process enhancements, introduce automation, or streamline operations.
• Team Management: This role involves leading and supervising a team of assembly technicians and operators. The Assembly Manager provides guidance, training, and support to ensure that employees perform their tasks effectively and efficiently.
• Safety and Compliance: They are responsible for enforcing safety protocols and ensuring compliance with relevant industry regulations and standards. This includes maintaining a safe work environment, conducting safety training, and addressing any safety concerns or incidents.
• Inventory Management: The Assembly Manager oversees inventory levels, ensures the availability of required components and materials, and helps manage stock control to avoid shortages or excesses.
• Collaboration and Communication: They collaborate with other departments, such as engineering, procurement, and quality assurance, to coordinate activities and address any cross-functional issues. Effective communication with stakeholders, such as customers and suppliers, is also essential.
• Performance Monitoring and Reporting: The Assembly Manager tracks production performance, monitors key performance indicators (KPIs), and prepares regular reports to evaluate productivity, quality, and other relevant metrics. They analyze data and provide recommendations for improvement.
• Experience working in a union shop and familiarity with union labor laws should be preferred.

Job Requirements:

• 3-5+ years of working experience in custom metal fabrication electrical equipment in an industrial setting.
• Ability to read blueprints, bill of material (BOM’s), schematics, diagrams, and technical orders to determine best methods and sequences of product assembly.
• An effective leader who can help level load the factory and can plan a lookout for 3-4 weeks so that the company’s overhead expenses for overtime in the shop stay within budget.
• Should be a Team Player and an Inclusive Leader.
• Knowledge about hand tools and measuring devices.
• Knowledge about EV products.
• Knowledge of Low Voltage or Medium Voltage Switchgear or components.
• Should have a particularly good understanding of Operational Excellence process improvements.
• Ability to work in a loud environment.

Education:

• A bachelor’s degree in engineering.
• Certification in Six Sigma or other process improvement methodologies is preferred.

NTG Staffing is seeking a Manufacturing Engineer for a company in Northvale, NJ. This is a direct hire opportunity. The company is seeking a candidate with specific experience in injection molding or metal stamping. Must be local to be considered.

Overview

• Responsible for designing, implementing, and optimizing manufacturing processes to improve efficiency, reduce costs, and maintain product quality.
• Uses production data analysis, process improvements, and technology implementation to support operational excellence.
• Collaborates cross-functionally with engineering, production, and quality teams to ensure successful product launches and ongoing manufacturing performance.

Key Responsibilities

• Improve manufacturing efficiency by analyzing workflows, equipment layout, and facility space utilization.
• Monitor and control manufacturing costs, including labor, materials, and production expenses.
• Identify process improvement opportunities and implement solutions to reduce waste and increase productivity.
• Develop and enforce quality control procedures to ensure products meet established standards.
• Lead pre-launch activities such as prototype, pilot, and validation builds to ensure smooth transition to full production.
• Partner with engineering, design, and production teams to achieve operational and manufacturing goals.

Core Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum of 3 years of Manufacturing Engineer experience.
• Automotive industry experience preferred.
• Strong analytical skills with ability to interpret production data and drive improvements.
• Proven problem-solving skills related to manufacturing processes.
• Strong organizational skills, attention to detail, and ability to meet deadlines.

Operations Technician I

Location: Rahway, NJ Work Environment: On-Site

Job Summary

The Operations Technician I is an entry-level professional responsible for executing technical tasks and supporting critical operational activities. This role is essential to the timely packaging, labeling, warehousing, and distribution of bulk and finished clinical materials.

The successful candidate will ensure full compliance with Quality-related aspects of Global Clinical Supply Operations, including inventory management, SOP authoring, and supporting internal inspections.

Key Responsibilities

Clinical Supply & Logistics

• Perform primary and secondary packaging of drug products, biologics, and vaccines.
• Execute distribution activities, including order processing and drug picking, packing, and shipping.
• Manage all tasks related to clinical label printing and production.
• Oversee warehousing activities, including bulk component inventory movement and accuracy.
• Maintain optimal inventory levels for consumables through proactive ordering.

Compliance & Quality Assurance

• Maintain cGMP and safety training to site requirements at all times.
• Author or revise Standard Operating Procedures (SOPs) and support batch record reconciliation.
• Support investigations into root causes and assist in the creation of Corrective and Preventative Actions (CAPAs).
• Act as a Subject Matter Expert (SME) during internal or external audits from regulatory agencies and safety bodies.

Technical Operations

• Operate within cold vaults, walk-in CTUs, and stand-up CTUs.
• Execute assigned technical tasks with a high degree of reliability and follow-through.
• Utilize SAP for technical activities and maintain accurate, detailed documentation.
• Engage in creative problem-solving and provide analysis to anticipate technical obstacles.

Qualifications & Skills

Education & Experience

• Bachelor’s degree preferred; candidates with relevant experience will be considered.
• 0–3 years of experience in a related field (or 3+ years of relevant experience for candidates without a degree).
• Experience using and wearing respiratory equipment.
• Training or experience in forklift and pallet jack operation.

Technical Knowledge

• Strong understanding of Good Manufacturing Practice (GMP) principles.
• Knowledge of quality and safety requirements for pharmaceutical packaging and handling.
• SAP experience is highly desired.
• Equipment operation and repair skills.

Physical Requirements

• Ability to repetitively lift, carry, push, and pull up to 50 lbs.

General Competencies

• Exceptional organizational skills and meticulous attention to detail.
• Strong problem-solving and troubleshooting abilities.
• Ability to quickly learn new systems and demonstrate in-depth knowledge of GMP processes.

About Made Scientific

Made Scientific is a leading US-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 Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.