Information Technology Jobs in Franklin Park, NJ
198 positions found
Job Title: Project Administrator - Data Center Information Technology/Design/Engineer Firm
Job Type: Full-time
Job Location: On-Site Edison, NJ
Project Administrator
NJ Data Center growing Information Technology/Design/Engineer Firm is seeking a Project Administrator to join our team. The Project Administrator is responsible for managing the administrative tasks and logistical aspects of data center construction or expansion projects, including coordinating with various teams, tracking project progress, maintaining documentation, and ensuring smooth execution of project activities under the guidance of a project manager, all while adhering to deadlines and budget constraints; essentially acting as the organizational backbone for the project.
Responsibilities include but are not limited to:
- Support project team on all administrative tasks and duties.
- Heavy client/vendor/supplier interaction.
- Preparation of spreadsheet reports, contracts documents, purchase and change order requests, presentations, and correspondence.
- Receive, maintain and distribute submittals, RFI's, shop drawings and establish project log to record receipt and disposition of same.
- Coordinate project meetings and travel arrangements.
- Maintain electronic and manual database of all project files and archives.
- Other responsibilities normally performed in the execution of a Project Administrator position according to standard Architectural/Engineering industry practices.
- Assist architects/engineers with editing/issuing project book specifications (electronic IE: Master Specs).
Qualifications:
- Three to five years experience in Engineering firms or related fields.
- BA is recommended.
- Must exhibit initiative, judgment, and quality in performance and responsibilities.
- Deadline and detail oriented.
- Proficiency in Microsoft Office, Word, Excel, Outlook, Power Point.
- Ability to work well with multi disciplines in a fast paced environment.
Work Schedule:
This is a full-time job position. In office, not remote or virtual.
Normal business hours are Monday thru Friday 8-5pm.
Benefits:
- 401 k match to $3500
- Full health medical/dental/prescription/life insurance (75% paid by employer 20-25% paid by employee)
- After 3/5 years eligibility based on rating for company owned NJ shore house
- Tuition reimbursement for employee
- Subjective year end bonus plan(end September)
- Awards/recognition for superior effort and extraordinary excellence
- Longevity awards 5/10/15/20/25/30 plus years
- After 15 years education assistance for children eligibility
- After 15 years eligibility for additional retirement compensative (elective)
BRUNS-PAK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity and/or expression, national origin, disability, veteran, or other protected status.
Infosys is seeking Java AEM Developer. This position will interface with key stakeholders and apply your technical proficiency across different stages of the Software Development Life Cycle including Requirements Elicitation, Application Architecture definition and Design; play an important role in creating the high level design artifacts; deliver high quality code deliverables for a module, lead validation for all types of testing and support activities related to implementation, transition and warranty; be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued.
Required Qualifications:
- Bachelor’s degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
- Candidate must be located within commuting distance of Boston, MA or Princeton, NJ or willing to relocate to the area. This position may require travel to project locations.
- Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time.
- At least 4 years of Information Technology experience
- 4 years of hands-on development experience in Adobe Experience Manager and Java.
- Strong experience with AEM as a Cloud Service and AEM On-Prem.
- In-depth knowledge of Sling, OSGi, JCR, Dispatcher, HTL, and AEM core architecture.
- Strong proficiency in Java, J2EE, Servlets, Spring (optional), and REST APIs.
Preferred Qualifications:
- Experience with unit testing frameworks like JUnit, Mockito, etc.
- Strong understanding of HTML5, CSS3, JavaScript, jQuery, and modern JS frameworks eg react JS.
- Design and develop complex components, templates, dialogs, and workflows within AEM.
- Build scalable, reusable, and maintainable AEM solutions aligned with enterprise architecture.
- Implement AEM as a Cloud Service features, including Sling models, Content Fragments, Experience Fragments, and Core Components.
- Upgrade, migrate, and optimize AEM On-Premises instances to AEM Cloud.
- Experience with CI/CD pipelines (Jenkins, GitHub Actions, Azure DevOps, etc.).
- Knowledge of cloud platforms: Adobe Cloud Manager, AWS/Azure/GCP (added advantage).
- Excellent problem-solving skills and performance debugging.
- Strong communication, documentation, and client-facing skills.
- Experience in Agile/Scrum environments.
Estimated annual compensation range for this role will be as follows:
In NJ/ MA: Min $76071 to Max $98893; Min $78903 to Max $102574
The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face. Travel may be required as per the job requirements.
EEO/About Us :
Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.
Duration: 1 year Assignment
Location: Open to candidates in cities (Chicago, IL, All Client CA location and Branchburg, NJ). Onsite preferred.
What are the top 3-5 skills, experience or education required for this position:
* Background in robotics/sales/applications engineering with hands-on experience across leading platforms (e.g., KUKA, FANUC, ABB, UR, MiR, Otto).
* Proven track record deploying robotics in manufacturing, logistics, or laboratory processes-translating operational needs into automated solutions.
* Experience in regulated industries (Pharma/biotech/medical devices) with familiarity with GMP, ISO, FDA requirements and validation (IQ/OQ/PQ).
* Competence in project documentation, risk assessments, and compliance documentation.
* Strong communication and stakeholder management across technical and non-technical teams; adaptable in multicultural, multidisciplinary environments.
Roles and Responsibilities
Primary Responsibilities:
* Support the execution of robotics projects at multiple US sites including Puerto Rico, contributing to planning, implementation, and delivery.
* Collaborate with cross-functional site teams to clearly define project scope, objectives, and deliverables that align with both business and technical needs.
* Build and maintain strong relationships with site teams, stakeholders, and vendors to anticipate challenges, resolve roadblocks, and ensure successful project outcomes across a range of environments-including highly regulated sectors like Pharma, biotech, or similar.
* Articulate the value proposition and expected benefits of robotics projects, incorporating productivity, efficiency, safety, and (where relevant) compliance considerations.
* Manage vendor and third-party relationships covering selection, procurement, and ongoing evaluation of products and services, while ensuring vendors can meet specific requirements of regulated industries if applicable.
* Provide hands-on technical leadership to fill capability gaps within project teams, from requirement gathering to solution delivery and troubleshooting.
* Identify and assess opportunities for future robotics projects, leveraging best practices from both industrial and regulated environments to build a long-term project pipeline (e.g., 2027 and beyond).
* Regularly gather input and feedback from each site to guide the organization's robotics and automation strategy, addressing both operational value and compliance readiness where necessary.
* Lead and oversee small-scale proof-of-concept (PoC) projects, including piloting new technologies and approaches in various settings such as manufacturing, logistics, or laboratory environments.
* Travel as needed within the US with an ability to adapt to diverse regulatory requirements and operational cultures.
Preferred Experience and Skills:
* Background in robotics engineering, sales engineering, applications engineering, or similar functions, ideally with experience across leading robotics platforms (e.g., Kuka, FANUC, ABB, UR, MiR, Otto, etc.).
* Proven track record of deploying robotics in manufacturing, logistics, or laboratory processes-converting operational needs into effective automated solutions.
* Experience working in regulated industries (such as Pharma, biotechnology, or medical devices) is an advantage, particularly familiarity with Good Manufacturing Practice (GMP), ISO, or FDA requirements, and validation processes (IQ/OQ/PQ).
* Competence in handling project documentation, risk assessments, and compliance documentation when required.
* Strong communication and stakeholder management skills, with the ability to work across technical and non-technical teams worldwide.
* Adaptive and open mindset, comfortable working in multicultural and multidisciplinary teams, and in both regulated and unregulated environments. .
We are seeking a skilled IT Technician - Warehouse to join our team onsite in Somerset, New Jersey. In this role, you will provide essential technical support services in Bank's Warehouse. This position involves troubleshooting, resolving incidents, managing inventory, and performing various technical and logistical tasks.
Client: Banking Sector
Employment Type : contract for 6 months with high possibility of extension
Location: Onsite in Somerset, New Jersey
Pay Range : $25 - $30/hr on W2
Training: 8:00 AM - 5:00 PM for the first week
Post-Training Shift: 11:00 AM - 8:00 PM Monday to Friday or Tuesday to Saturday
Qualifications
- 1-2 yrs of Prior experience in end-user technical support or related roles is preferred.
- 1+ yrs of Prior experience working in a warehouse
- Ability to perform physical tasks, including lifting up to 40-50 pounds.
- Strong organizational and problem-solving skills.
- Excellent communication and interpersonal abilities.
Key Responsibilities • Respond to and resolve Workspace Incidents and IMAC (Install, Move, Add, Change) requests. • Manage inventory levels at designated Hub locations. • Perform imaging, asset tagging, and shipping/receiving activities, including pick, pack, and ship tasks. • Handle warehouse-related activities and lift up to 40-50 pounds as required. • Utilize company provided tools, including a laptop and other resources, to deliver services effectively.
Requirements • Adhere to all security practices and Code of Conduct while on-site. • Maintain professional and industry-standard attire and behavior. • Carry proper identification as a representative of the Reseller at all times. • Respond to emails and phone calls promptly during business hours using a mobile device. • Ensure a safe work environment; failure to provide this may affect performance obligations.
Job Title: Rancher & Kubernetes SME
Location: Princeton, NJ - 08540
Mode: Contract Role – Onsite
only W2
Minimum 15+ years of experience required.
Qualifications:
- Design and implement Rancher-managed Kubernetes clusters (RKE, RKE2, K3s, EKS, AKS, GKE).
- Architect high availability (HA) Rancher setups.
- Define multi-cluster and multi-tenant strategies using Rancher projects, namespaces, and RBAC.
- Integrate Kubernetes with VMware, Bare Metal, and Cloud platforms.
- Establish standardized cluster blueprints and reference architectures.
- Act as final escalation (L3) for Kubernetes and Rancher incidents.
- Diagnose and resolve Control plane failures
- etcd performance and corruption issues
- Pod scheduling and node pressure issues
- CNI (Calico / Cilium) networking problems
- CSI storage failures (Ceph, Longhorn, EBS, Azure Disk, NFS)
- Perform root cause analysis (RCA) and provide preventive recommendations.
- Install, upgrade, and maintain Rancher Server.
- Manage cluster lifecycles using Rancher UI & APIs.
- Implement and manage Rancher RBAC, Authentication (AD / LDAP / Azure AD / SSO)
- Global & cluster-level policies
- Maintain Rancher backups, DR, and recovery procedures
- Enforce Kubernetes security best practices like Pod Security Standards (PSS)
- Network policies and Secrets management
- integrate Kubernetes with CI/CD tools e.g., GitHub Actions, GitLab CI, Jenkins, Argo CD
- Enable GitOps workflows for application and cluster configuration.
- Support Helm chart development and lifecycle management.
- Assist development teams with Deployment strategies, Resource optimization
- Troubleshooting application issues on Kubernetes
Experience:
- 6–10+ years in Linux / Infrastructure / Cloud
- 3–5+ years hands-on Kubernetes production experience
- Strong expertise in Rancher (RKE / RKE2 / K3s)
- Deep understanding of:
- Kubernetes control plane
- etcd
- Networking (CNI)
- Storage (CSI)
Thanks,
Rahul Gupta
Direct: (732) 743-7543
Location: Branchburg, NJ
Duration: 2 Year (Potential Extension)
Hybrid Onsite Schedule, in office Tue, Wed, Th, with the ability to be remote Mon, Fri. If business needs require on-site presence Mon/Fri it may be necessary.
Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
* Serve on project technical team, consisting of cross-functional resources including but not limited to R&D, PDS&T, Quality, Biocompatibility, and Regulatory.
* Partner with R&D to identify user and technical product requirements for a medical device product.
* With Technical Lead, Develop Design Verification & Validation strategy.
o Support Design Verification (planning, fixture development, method development, test method validation, protocol development, and test execution).
* Drive the creation and execution of protocols and reports.
* Manage Design History File content.
* Participate in prototyping activities to transform concepts into functional devices.
* Perform laboratory testing, including independently designed experiments to further project goals.
* Conduct statistical analyses using software such as MiniTab or JMP to evaluate data and support design decisions.
* Ensure compliance with company and industry standards regarding safety, quality, and regulatory policies (including GxP).
Qualifications:
List required and preferred qualifications (up to 10). Include education, skills and experience.
* Experience with new product development, including defining user and technical product requirements.
* Experience with Design controls, including Design Verification & Validation strategy development and execution.
* Experience with laboratory testing as well as subsequent data analysis using statistical methods.
* Experience with medical device regulatory submissions.
* Experience with biological-based products preferred.
* Bachelor's Degree or equivalent education with 5 or more years of experience or Master's degree or equivalent education with 3 or more years of experience.
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. Operating from two U.S.-based manufacturing facilities, 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 Director of Manufacturing Science & Technology (MSAT) will lead the technical oversight, process lifecycle management, and technology transfer activities for cell therapy manufacturing programs within a CDMO environment. This role is responsible for ensuring robust, scalable, and compliant manufacturing processes for autologous and allogeneic cell therapy products from clinical development through commercial manufacturing.
The Director will work cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and Client Program teams to support client programs, drive continuous process improvement, and ensure successful technology transfers into GMP manufacturing.
This role is based in Princeton, NJ and is fully onsite.
Key Responsibilities
• Provide scientific and technical leadership for cell therapy manufacturing processes, including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.
• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.
• Lead troubleshooting efforts and root cause analysis for manufacturing deviations, investigations, and CAPAs.
• Drive implementation of process monitoring and control strategies.
• Lead technology transfer activities from clients or internal process development teams into GMP manufacturing.
• Develop and review technology transfer plans, process descriptions, risk assessments, and gap analyses.
• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities, as applicable.
• Oversee continued process verification (CPV) and lifecycle management for manufacturing processes.
• Lead process characterization, comparability studies, and validation support activities.
• Provide real-time technical support to GMP manufacturing operations for clinical and commercial batches.
• Review batch records, deviations, and change controls related to process changes.
• Present technical updates during client meetings and governance reviews.
• Support proposal development, technical due diligence, and onboarding of new client programs.
• Ensure MSAT activities comply with cGMP, FDA, EMA, and ICH regulatory requirements.
• Contribute to regulatory filings, including INDs, BLAs, and comparability packages.
• Support regulatory inspections and client audits.
• Build and lead a high-performing MSAT team, including scientists and engineers.
• Provide mentorship, technical guidance, and performance management.
• Develop MSAT strategy aligned with organizational growth and client pipeline.
• Perform other duties as assigned by the Head of Development.
Required Qualifications
• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or a related field.
• 10–15+ years of experience in biopharmaceutical manufacturing or process development.
• 5+ years of leadership experience in MSAT, technical operations, or process development.
• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).
• Experience working within a CDMO environment strongly preferred.
• Deep knowledge of:
• Cell culture and expansion technologies
• Viral vector transduction or gene editing workflows
• Closed and automated cell therapy manufacturing platforms
• Cryopreservation and fill-finish processes
• Experience with technology transfer, process validation, and process characterization.
• Familiarity with statistical process monitoring and data analytics tools.
• Strong cross-functional leadership and project management skills.
• Experience working directly with biotech clients.
• Excellent written and verbal communication skills.
• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.
Preferred Qualifications
• Experience with commercial cell therapy manufacturing.
• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).
• Knowledge of viral vector manufacturing processes.
• Experience supporting BLA submissions or late-stage clinical programs.
Physical Requirements
• Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable regulations, including meeting productivity standards.
• Ability to maintain regular and punctual attendance.
• Must be willing to become gown-qualified and work in BSL-2 lab, CNC, ISO7, and ISO8 environments.
• Ability to lift and carry up to 30 lbs.
• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.
• Ability to sit or stand for extended periods.
• Must be comfortable working with cell-based products, chemicals, or hazardous materials.
About Wakefern
Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite, Price Rite, The Fresh Grocer, Dearborn Markets, Fairway Market, Gourmet Garage and Di Bruno Bros. banners.
Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern's co-operative members benefit from the company's extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices.
About You
Your contribution
As a member of the Retail Operations team, this associate will be responsible for consulting with our ShopRite and Alternate Banner Members, store management and retail staff with regard to the operations and merchandising of our Produce Departments. The Produce Merchandiser will consult with our Members, retail staff and subsidiaries on all innovative/state of the art merchandising strategies and technological advances to ensure long-term growth and profitability. A successful merchandiser analyzes market trends, understands the importance of seasonality and creativity in the craft. This associate will counsel our stores regarding departmental sales, gross profit, labor, shrink, product quality, training and customer service. This is accomplished through the establishment of Member/Store specific business plans which enhance market share, build sales, and ensure profitability in their respective trade areas. This merchandiser will conduct store visits to ensure merchandising standards and standard operating procedures (SOPs) are in place in order to deliver consistent execution and financial results by leading and coaching for improvement. This individual shares best practices throughout the cooperative. In addition, this merchandiser will also be charged with the implementation and successful execution of all resets, remodels, new store setups, divisional programs, initiatives, and openings.
What you will do
- Provide knowledge and product information on various produce commodities to Wakefern procurement staff, Members, and Store personnel to enhance merchandising mix and sales opportunities.
- Convey leading edge knowledge of new, innovative concepts to ShopRite Members, Alternate Banner Members, Supervisors, and Store staff.
- Counsel Membership on all regulatory laws and compliance issues.
- Develop store Member Business Plans with sales goals, objectives, and measurables.
- Conduct quarterly Produce Manager/Supervisor meetings to introduce new products, concepts, and innovations plus solicit feedback on how Wakefern can provide better support and service.
- Monitor ad activity and retail pricing in ShopRite market areas.
- Assist in all remodels and new store openings.
- Develop value-added product lines to support the customer trends.
- Conduct and monitor yields of products to ensure proper sales value and gross profit at store level.
- Liaison with procurement staff to solicit vendors and products that are more advantageous to promote.
- Development of promotional P.O.S. materials pamphlets, and brochures
- Provide technical support to the Members to enhance sales, profits, and customer image. (Shrink Clinic, Training, etc.)
- Coach and counsel merchandising staff to focus on supporting corporate and department goals and objectives through written business plans and measurables.
- Work with Human Resources to develop retail training seminars and enhance our overall operation, customer image, and performance.
- In conjunction with Tech, develop user-friendly sales and gross profit reports and merchandising information (ie: QA scores, customer service measurements, demographics, etc.) to support perishables goals and objectives.
What we're looking for
- Four year college degree strongly preferred. Equivalent retail supermarket experience will be considered in lieu of college degree.
- Minimum 3 years in Produce Department management / supervisory experience in operations and merchandising
- Refined organizational and problem-solving skills; able to develop ideas and procedures
- Strong time management skills; must be able to follow-through on multiple projects and meet aggressive deadlines
- Excellent written and verbal communication and interpersonal skills with an ability to convey information clearly and concisely to various audiences
- Expertise in processes and utilization of reports that drive retail excellence within our Produce Departments
- Ability to train and coach associates at store level in Produce operations and merchandising standards
- Proficiency in taking and reviewing SI inventory
- Knowledge of retail operations related to sales, gross profit, shrink, labor requirements and retail merchandising
- Extensive production equipment knowledge and department design skills
- Proficiency in Microstrategy, Production Planning, ARIA, Nielsen Activate, and Rapid preferred
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Flexibility regarding extensive travel (overnight stays required).
- Valid driver's license and good driving record.
How you will succeed
- Communicate Effectively: Communicates thoughts and ideas in a well-organized manner, encouraging two-way communication.
- Build Relationships: Creates cross-functional partnerships through the development and maintenance of constructive and cooperative relationships.
- Stay Competitive: Demonstrates a mindset of continuous improvement while exhibiting passion and enthusiasm for their work.
- Embrace Change: Looks for new ways of working by supporting advancements in processes and technology.
- Develop You: Identifies and capitalizes on opportunities for personal and professional career growth.
- Drive for Results: Supports divisional and strategic objectives through achievement of work goals.
How you will work
- Ability to drive long distances and travel for consecutive hours
- Ability to stand or walk for extended periods of time
- Ability to lift 25 lbs or more
- Ability to stay overnight for multiple days, including week long trips and weekends
Company Perks
- Vibrant Food Centric Culture
- Comprehensive medical, dental and vision package
- Competitive Salary and Paid Time Off
- Fitness Reimbursement and Well-Being Program
- Corporate Training and Development University
- Collaborative team environment
- Paid Parental Leave
- 401K
- Matching Gifts and Community Volunteer Involvement
Compensation and Benefits
The salary range for this position is $65,000 - $80,000. Placement in the range depends on several factors, including experience, skills, education, geography, and budget considerations.
Wakefern is proud to offer a comprehensive benefits package designed to support the health, well-being, and professional development of our Associates. Benefits include medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off, holidays, and parental leave. Associates also enjoy access to wellness and family support programs, fitness reimbursement, educational and training opportunities through our corporate university, and a collaborative, team-oriented work environment. Many of these benefits are fully or partially funded by the company, with some subject to eligibility requirements.
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.
