Engineering Structures Journal Jobs in Dayton, NJ
64 positions found — Page 4
Position: Technical Product Analyst Location: Hybrid New Brunswick, NJ (2 3 days onsite) Travel: Up to 10% domestic and international Position Summary: As a Technical Product Analyst (TPA), you will support the Technical Product Owner (TPO) in translating business needs for Global Trade Compliance products to ensure alignment with business objectives.
You will collaborate with Business Stakeholders, XD Designers, Architects, and Technology teams to ensure that all aspects of the Software Development Lifecycle meet or exceed customer expectations.
Key Responsibilities: Understand user needs and translate them into detailed requirements Build use cases and write/manage user stories, process flows, and visualizations Communicate product vision and requirements to developers and testers Stay 2 3 sprints ahead of the squad ensuring backlog readiness and definition of done Support UAT preparation and participate in testing when required Document confirmed business processes for development and IT support reference Apply business process improvement methods for optimization Track metrics and build reports to measure product delivery progress Ensure SDLC documentation, system configuration, and compliance activities are up to date Support and/or facilitate system demos when needed Required Qualifications: Experience gathering requirements and translating them into product vision Strong understanding of business processes and digital product delivery Experience managing product backlogs and release plans in Agile environments Knowledge of customer journeys and customer experience Strong analytical and problem-solving skills with attention to detail Experience with JIRA, SQL, Databricks, and Alteryx Foundational knowledge in Data Engineering, Cybersecurity, Intelligent Automation, and Emerging Technologies Preferred Qualifications: 2 3 years of experience in Global Trade Compliance or Transportation Experience implementing or supporting Global Trade Management or International Transportation Management Systems Familiarity with Trade Automation by E2Open, ERP systems (Atlas, MARC, JDE, S4) Experience with Roadmunk Business Requirements, JIRA, Analytical Thinking, Business Processes, Communication Skills, Problem Solving, Attention to Detail, Business Process Improvement, Requirements Analysis, Automation, SQL Databases, Cyber Security, Enterprise Resource Planning, Business Excellence, User Stories, Testing Skills, Agile Methodology, Software Engineering, Acceptance Testing, Alteryx, Backlogs, Customer Experience, Databricks, Trade Compliance, Transportation Management, Business Planning, Information Engineering, Metrics, System Configuration, Systems Development Life Cycle, Technical Support
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.
SUMMARY/OBJECTIVE:
The Senior Director, Operations is responsible for leading day-to-day operational execution across manufacturing, packaging, project management, facilities, and warehouse functions within a cGMP, CDMO, or CMO environment. This role translates company strategy into operational plans, drives performance against key metrics, and ensures safe, compliant, and efficient delivery of client programs. The Senior Director partners closely with Quality, Research & Development, Operations, Logistics, Finance and Business Development to support growth, client satisfaction, and inspection readiness.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide operational leadership and oversight for both U.S. and Ireland-based operations teams, ensuring alignment of processes, priorities, and performance expectations across sites.
- Lead daily operations across manufacturing and packaging services, ensuring schedule adherence, quality, and throughput.
- Own operational performance metrics (e.g., OTIF, right-first-time, labor utilization, cost control, and equipment performance).
- Translate strategic objectives from executive leadership into executable operational plans and priorities.
- Provide leadership and development for operations managers and cross-functional teams.
- Partner with Project Management to align production schedules with client timelines and contractual commitments.
- Ensure compliance with cGMP, FDA, DEA (as applicable), and company quality systems; support internal and external audits.
- Drive continuous improvement and operational excellence initiatives, including lean practices and waste reduction.
- Collaborate with Quality on deviation investigations, CAPAs, and risk mitigation actions.
- Support client onboarding, tech transfer, and scale-up activities to ensure successful execution.
- Work with Facilities and Engineering to optimize equipment utilization, maintenance planning, and capacity expansion.
- Collaborate with Warehouse teams to ensure material availability and inventory accuracy.
- Provide operational input during new business assessments and client proposals.
- Maintain effective communication with senior leadership on performance, risks, and resource needs.
- Comply with all company and site policies and procedures and perform other duties as assigned
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
- 8–12+ years of experience in cGMP pharmaceutical manufacturing and/or packaging environments, including at least 5 years supporting clinical and commercial manufacturing and packaging operations.
- 5+ years of progressive leadership experience managing operations teams.
- Experience in a CDMO/CMO or multi-client manufacturing environment required.
- Demonstrated success leading regulatory inspections and client audits.
- Strong understanding of pharmaceutical packaging, production planning, and operational controls.
COMPETENCIES/SKILLS:
- Strong operational leadership and execution mindset.
- Excellent analytical, problem-solving, and decision-making skills.
- Ability to interpret data and drive performance improvements.
- Effective communication and stakeholder management skills.
- Financial acumen with experience managing budgets and operational costs.
- Ability to lead cross-functional teams in a fast-paced CDMO environment.
- High integrity, professionalism, and accountability
SUPERVISORY RESPONSIBILITIES:
Yes. Typically includes Production/Packaging Managers, Warehouse leadership, Facilities leadership, Project Management and other operations personnel as assigned.
WORK ENVIRONMENT:
Hybrid office and manufacturing environment; routine presence on the production floor required.
SCHEDULE:
On-site 5 days per week in Cranbury, NJ office
SALARY:
$190,000 - $240,000
PHYSICAL DEMANDS:
Combination of office-based work and time in warehouse/manufacturing areas. Ability to stand, walk, and move through production areas as needed.
TRAVEL:
Up to 20–30% travel may be required based on client and business needs.
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.
We offer competitive pay, training and growth opportunities and a positive work environment.
Main Duties & Responsibilities: Follow proper testing & diagnostic procedures to accurately solve vehicle issues Maintain a clean, safe working environment Perform basic auto care and maintenance tasks such as oil changes, fluid level checks, and tire rotation Perform emissions inspections, safety checks and similar state-regulated vehicle examinations Test the functionality of parts and systems Repair brake and steering systems Diagnose and repair electrical and electronic systems Replace or repair transmissions and fuel components as needed Repair cooling components and systems including air conditioners and engine cooling Complete tire changing, balancing, and installation Prepared to get additional certification as needed Willingness to learn with hands-on training Communicate effectively with Service Advisor about vehicle status and required parts and labor Explain automotive repairs and issues to non-technical employees and customers as needed Uphold the culture and values of our independently owned shop.
Qualifications: Possess a valid state driver’s license for conducting test drives High school diploma or equivalent education, advanced technical education preferred Possession of or ability to obtain ASE certification Strong written and verbal communication skills Analytical skills Coordination and physical stamina When you join the team at your local, independently owned TechNet Professional Service Center, you’ll be working with a shop that takes pride in what they do.
A local shop in your community, backed by the support of a Nationwide network.
That is just part of what sets a TechNet Automotive Service Center apart from the rest.
Come join #TechNetNation!
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Will Call Supervisor oversees daily will call and expedited order operations, ensuring orders are processed accurately, efficiently, and on schedule.
Responsibilities include completing all will call orders, capturing proof of delivery (POD) documentation, and coordinating expedited requests such as Turtle Express and courier pickups.
Additionally, this position manages the returns team and assists the AM Warehouse Supervisor and Manager in morning warehouse operations, maintaining a safe and organized work environment, enforcing safety policies, and supporting warehouse productivity.
Supervisors are cross trained in multiple operational areas and may provide coverage as needed to ensure efficient daily operations.
What You'll Do: Ensure all employees have required PPE and perform tasks safely.
Oversee daily will call operations (order picking, staging, and completion).
Properly capture and record will call proof of delivery (POD) documentation.
Coordinate expedited order requests (Turtle Express, courier pickups, priority orders).
Accurately receive all PO pickups into the system in a timely manner.
Sort relay orders to appropriate delivery routes and ensure paperwork is given to dispatch.
Supervise returns team to process returns accurately and promptly.
Support AM warehouse functions: replenishments, receipts, transfers, and putaways.
Inspect forklifts and powered industrial equipment before each shift.
Conduct toolbox and safety meetings with will call and returns teams as needed.
Complete daily operational checklists and document all will call and return activities.
Learn and enforce company agreements and working rules.
Complete near miss and/or accident reports as required.
Conduct or oversee new hire training in will call and returns areas.
Work with Quality and Safety Manager on training targets, including ADP requirements.
Coach employees to prevent repeated errors and improve performance.
Assist with warehouse labor as needed (picking, packing, other tasks).
Be cross-trained and provide coverage in multiple operational areas to ensure smooth daily distribution center operations.
What You'll Bring High school diploma or equivalent required.
Minimum of 3–5 years of warehouse or distribution center experience.
Previous experience in a lead, coordinator, or supervisory role preferred.
Strong understanding of warehouse operations including will call, receiving, returns, and order fulfillment processes.
Experience working with warehouse management systems (WMS), RF scanners, and inventory systems.
Ability to prioritize multiple tasks and manage expedited and time-sensitive orders.
Strong communication and leadership skills with the ability to coach and guide team members.
Working knowledge of warehouse safety standards and OSHA guidelines.
Ability to operate or become certified to operate forklifts and other powered industrial equipment.
Ability to lift 50 lbs.
and work in a fast-paced warehouse environment.
Proficiency with basic computer systems and Microsoft Office applications.
What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
Job Title: Survey CAD Technician
Location: Edison, NJ (In-Office)
Position Overview
We are seeking a detail-oriented and experienced Survey CAD Technician to join Clients team in Edison, NJ. The ideal candidate will have strong proficiency in AutoCAD Civil 3D within a surveying and/or construction environment and a solid technical background. This role requires the ability to collaborate effectively with engineers, designers, survey technicians, and project managers to produce high-quality survey drawings and plans that meet company and industry standards.
What We Offer
- Competitive compensation based on experience.
- Opportunity to work on diverse and challenging survey projects.
- Collaborative team environment.
- Professional growth and development opportunities.
Requirements:
- Must be able to commute to office in Edison, NJ.
- Must have experience using AutoCAD Civil 3D in a surveying and/or construction environment.
Essential Functions & Responsibilities
- Plan and prepare preliminary layouts and detailed design drawings from engineering notes, sketches, and other reference materials, ensuring compliance with company standards and applicable codes.
- Prepare ALTA/NSPS Land Title Surveys, Boundary Surveys, Topographic Surveys, Location Surveys, Utility Surveys, Roadway Topographic Surveys, Subdivision/Lot Consolidation Plans, and As-Built Surveys.
- Perform calculations of survey points for construction layout purposes.
- Prepare construction cut sheets.
- Create survey plans from field crew data collector files (points), field sketches, digital photographs, and reference maps.
- Generate surfaces using 3D polylines and point data within Civil 3D.
- Research and obtain applicable standards and codes required by clients, municipalities, and counties through coordination with project managers, survey technicians, and administrative staff.
- Coordinate project requirements with team members and assist in completing required tasks to meet deadlines.
- Work closely with Engineers, Designers, and other Drafters to ensure coordinated design efforts are maintained.
- Utilize third-party applications to generate drawings based on specific project requirements.
- Process lidar scan data (preferred but not required).
- Prioritize and manage multiple projects while adhering to CAD standards and deadlines on a daily basis.
Qualifications:
- Proficiency in AutoCAD Civil 3D (required).
- Experience in a surveying and/or construction environment (required).
- Knowledge of lidar scan data processing (a plus).
- Proficiency in Microsoft Word and Excel.
- Strong technical background with attention to detail.
- Excellent organizational, communication, and time-management skills.
- Ability to multi-task and meet project deadlines.
- Team-oriented mindset with a collaborative approach to work.
If you are a motivated CAD professional with a strong background in surveying and a commitment to quality and accuracy, we encourage you to apply.
About the Company
A 130-person, multi-disciplined firm providing architecture, engineering, and environmental services. The Voorhees office serves as the firm's dedicated architecture presence in South Jersey. We are seeking an experienced Architectural Project Manager to support continued growth.
About the Role
Lead K–12 architectural projects from concept through completion. This is a client-facing role focused on project leadership, budgeting, scheduling, coordination, and representation at public meetings.
Responsibilities
- Manage K–12 projects from inception to completion
- Oversee schedules, budgets, and consultant coordination
- Serve as primary client liaison
- Represent the firm at Board of Education meetings
- Navigate permitting and regulatory processes
- Ensure projects meet quality, timeline, and financial goals
Qualifications
- 7+ years of architectural experience
- 3+ years of K–12 experience preferred
- Strong communication and presentation skills
- Professional, polished presence
- Licensure and Revit knowledge helpful but not required
Required Skills
- Strong communication and presentation skills
- Professional, polished presence
Pay range and compensation package
100% employer-paid individual health coverage
Hybrid work flexibility
Strong growth opportunity and comprehensive benefits
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!
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 Sterility Assurance Program Lead (Associate Director) is a quality and technical leader responsible for establishing, maintaining, and continuously improving a robust sterility assurance and contamination control program across GMP cell therapy operations, from clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual will work in close partnership with Technical Operations, QC, Site Quality Operations, Plant Operations, and MSAT to ensure consistent aseptic execution, clear functional accountability, and sustained compliance with global regulatory expectations for advanced therapies.
Key Responsibilities
Sterility Assurance & Contamination Control Program
• Design, implement, and sustain a comprehensive Sterility Assurance and Contamination Control Strategy (CCS) aligned with global GMP expectations for cell therapy manufacturing.
• Ensure sterility assurance principles are embedded across facility design, equipment, processes, personnel practices, and quality systems for both clinical and commercial operations.
• Maintain alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP Annex 1 & 2, ICH guidance, and evolving global expectations for ATMPs.
Aseptic Operations & Functional Ownership
• Define and govern clear functional ownership of sterility assurance activities across Technical Operations and Quality functions.
• Provide oversight to ensure appropriate independence, compliance, and cross-functional collaboration.
Environmental Monitoring & Data Oversight
• Oversee the design and maintenance of Environmental Monitoring (EM) programs, including EMPQ, EMRA, sampling plans, alert/action limits, and response strategies.
• Review EM trends and contamination indicators to maintain a sustained state of control.
• Lead cross-functional discussions on EM excursions, contamination events, and risk mitigation.
Aseptic Process Validation & Risk Management
• Provide sterility assurance leadership for aseptic process simulation and validation.
• Oversee media fill design, execution, and failure investigations.
• Lead contamination risk assessments for process changes, new equipment, facility modifications, or tech transfers.
• Drive root cause analysis and CAPA development related to sterility assurance events.
Quality Systems Interface & Continuous Improvement
• Author, review, and approve SOPs, policies, and standards related to sterility assurance and contamination control.
• Partner with Quality Systems to embed sterility assurance into deviation management, change control, CAPA, and training systems.
• Analyze sterility assurance trends to identify systemic risks and drive continuous improvement.
• Support sterility readiness for new site start-ups, expansions, tech transfers, and product launches.
Regulatory Inspections & Audit Support
• Act as Sterility Assurance SME during regulatory inspections, client audits, and internal audits.
• Lead inspection preparation, including gap assessments, mock audits, and SME coaching.
• Lead or support response drafting for sterility-related findings, including 483s, regulatory commitments, and client observations.
Leadership, Influence & Collaboration
• Provide mentorship and leadership to sterility assurance SMEs across sites.
• Influence and align stakeholders across Quality, Technical Operations, QC, MSAT, Facilities, and Program Management.
• Advise senior leadership on sterility assurance risks, contamination trends, and program maturity.
• Champion a proactive, science-based, and inspection-ready sterility assurance culture.
Required Qualifications
• Bachelor’s or Master’s degree in Life Sciences, Microbiology, Engineering, or related field.
• 10+ years of progressive experience in GMP-regulated cell therapy, gene therapy, biologics, or advanced therapy manufacturing.
• Deep expertise in aseptic processing and sterility assurance for non-terminally sterilized products.
• Strong working knowledge of global GMP regulations (FDA, EMA, ICH, Annex 1).
• Demonstrated experience supporting clinical and commercial GMP operations.
• Proven ability to lead cross-functional programs and influence without direct authority.
• Strong communication skills for diverse audiences, from operators to regulators.
• Experience leading or supporting inspections, client audits, and internal audits.
• Flexibility to work variable hours to support operations and inspections.
• Strong organizational skills and ability to manage competing priorities.
Preferred Qualifications
• Experience working in a CDMO with multiple clients and programs.
• Direct experience with EU Annex 1 implementation and contamination control strategy.
• Experience supporting late-stage to commercial transitions or high-growth environments.
• Certification or training in microbiology, aseptic processing, Lean, or Six Sigma.
Education Requirement
• B.S. in a related field required.
Physical Requirements
• Ability to perform job functions in compliance with all standards, including productivity and attendance.
• Willingness to work in CNC/ISO7-8 cleanroom environments.
• Ability to lift up to 25 lbs.
• Must be able to stand, bend, and perform physical tasks in manufacturing environments.
• Comfortable working with cell-based products and chemicals.
