Engineering Journal Jobs in Pennington, NJ
29 positions found — Page 2
About Cygnus Professionals, Inc.
Cygnus is a Princeton, NJ-headquartered global Business IT consulting and software Services firm with offices in the USA and Asia. Cygnus offers and enables innovation and helps our clients accelerate time to market & grow their business. Over 15 years, we have taken great pride in continuing our deep relationships with our clients.
For further information about CYGNUS, please visit our website Title: Data Architect
Location: Princeton, New Jersey – Onsite
W2 Contract
Job Summary
We are seeking an experienced Data Architect to design, build, and maintain scalable data architecture solutions supporting enterprise analytics, data integration, and digital transformation initiatives. The ideal candidate will work closely with business stakeholders, data engineers, and application teams to design robust data models, data pipelines, and enterprise data platforms that support advanced analytics and reporting.
Key Responsibilities
- Design and implement enterprise data architecture frameworks and best practices.
- Develop logical and physical data models for enterprise data platforms.
- Architect data lakes, data warehouses, and data integration solutions across cloud and on-prem environments.
- Collaborate with data engineers and application teams to build scalable data pipelines and ETL/ELT processes.
- Ensure data governance, data quality, security, and compliance standards are implemented across the data ecosystem.
- Evaluate and recommend data technologies, tools, and frameworks aligned with enterprise strategy.
- Provide architectural guidance for cloud-based data platforms (AWS/Azure/GCP).
- Optimize performance for large-scale data processing and analytics workloads.
- Support business intelligence, reporting, and advanced analytics initiatives.
Required Qualifications
- 10+ years of experience in data architecture, data engineering, or enterprise data management.
- Strong experience with data modeling (conceptual, logical, physical).
- Expertise with data warehouse and data lake architectures.
- Hands-on experience with ETL/ELT tools and data integration platforms.
- Experience with SQL and large-scale data platforms (Snowflake, Redshift, BigQuery, etc.).
- Experience working with cloud data platforms (AWS, Azure, or GCP).
- Strong understanding of data governance, data quality, and metadata management.
- Experience with big data technologies (Spark, Hadoop, Kafka) is a plus.
Preferred Skills
- Experience in Healthcare, Pharmaceutical, or Life Sciences domain.
- Knowledge of Master Data Management (MDM) and data catalog tools.
- Familiarity with BI tools such as Tableau, Power BI, or Looker.
- Strong communication skills to interact with business and technical teams.
Education
- Bachelor’s or Master’s degree in Computer Science, Information Systems, Data Science, or related field.
Cygnus Belief
We believe in our commitment to diversity & inclusion.
Equal Employment Opportunity Statement
Cygnus is an Equal Opportunity Employer. We ensure that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.
All our employment decisions are taken without looking into age, race, creed, color, religion, sex, nationality, disability status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other aspects of employment protected by federal, state, or local law. Applicants for employment in the US must have work authorization.
Job Description for Project Management Associate - Fulltime and Onsite.
Project Management Associate is accountable for working projects by organizing meetings and coordinating follow-ups with internal and external project stakeholders across the globe. The projects would include R&D, site transfers, technology transfers, site transfers, and any source variation. Coordinate shipment of innovator samples. Perform business analysis and create term sheets as required. This individual will report into Sr. Director, Corporate Development.
Responsibilities:
Projects:
· Drive 3rd party projects to completion
· Support the India team for approvals and documentation required from Bion team
· Organize meetings, publish meeting notes/action items, and follow-up on action items.
· Understand and manage project schedules, and critical path activities
· Follow up with vendors, and internal team on deliverables.
· Update the project tracker on weekly basis.
· Identify and inform the project issues to the project team and stakeholders, and work with the team to resolve issues
· Conduct lessons learned sessions upon project completion.
RLD Shipments:
· Identify RLD requirements, and create proforma invoices
· Coordinate RLD sourcing and shipments
· Track RLD shipments through delivery
Smartsheet:
· Implement Smartsheet across all locations
· Manage Smartsheet to generate weekly and monthly reports to track project progress
· Identify areas to expand Smartsheet implementation
API Vendors:
· Coordinate with Logistics/Vendors to ship and track project related shipments such as API, samples etc for key product launches
New Business Opportunities:
· Create market share reports
· Follow up on all licensing opportunities
· Create and generate reports weekly, monthly, and ad-hoc.
· Proficient in Microsoft Office Excel and Powe point applications
. Ability to build business case
Compliance:
· Stay compliant with Site training requirements in SOPs and cGMPs
Qualifications:
· Bachelor’s degree required, preferably in Engineering, Supply Chain or Operations
· 2 to 3 years of prior generics pharmaceutical project management and analysis experience
· Ability to work with cross-functional teams and multiple site teams
· Ability to work with collaborative project management tools
· Preferred experience in Microsoft Office applications including Visio, MS Project
Additional Qualifications:
· Problem solver, Go-getter, and ability to collaborate
· Ability to act in an ethical, honest and professional manner at all times
· Ability to speak and write English in a clear and understandable manner
· Must have the ability to carry out instructions furnished in both oral and written form
Job Location: BionPharma, Inc. Princeton, New Jersey.
Princeton Theological Seminary, established in 1812, is dedicated to forming Christian leaders to serve Christ's church, academia, and the world. Located in Princeton, NJ, the institution is renowned for its commitment to theological education and fostering a community of faith and learning. The Seminary combines academic excellence with a rich history, providing an environment for students to grow spiritually and intellectually. With a global perspective, it prepares faith-driven leaders for impactful service.
This is a full-time, on-site Electrician role based in Princeton, NJ. The Electrician will perform installation, maintenance, and repair of electrical systems and equipment across campus facilities. Responsibilities include diagnosing and troubleshooting electrical issues, performing routine preventative maintenance, ensuring code compliance, and collaborating with the facilities team to uphold safety standards. The candidate will be required to handle various electrical tasks, ensuring operational efficiency for a safe environment.
- Proficiency in Electrical Work and Electricity, with the ability to install and maintain electrical systems
- Strong background in Maintenance & Repair tasks, ensuring equipment functionality and safety
- Skilled in Troubleshooting, identifying, and resolving electrical issues efficiently
- Understanding of Electrical Engineering principles and code compliance
- Excellent problem-solving and organizational skills
- Relevant certifications and licenses to perform professional electrical work
- Ability to work independently and collaboratively as part of a team
- Prior experience in facility management or academic settings is a plus
Look no further!
The Borgen Project is an international organization that works at the political level to improve living conditions for people impacted by war, famine and poverty.
With 20 years of experience in the advocacy space, The Borgen Project has worked to support the passage of numerous bills that have benefitted close to 500 million people in developing countries.
Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog . This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your availability is limited, you can work ahead and complete the program in fewer weeks.
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Responsibilities will include:
Article writing.
Researching topics.
Assisting with The Borgen Project's advocacy efforts.
Assisting with fundraising. Create a personal fundraising campaign and meet targets.
Experience:
No prior experience is necessary, we're looking for people who are passionate about fighting poverty and righting wrongs, regardless of your GPAs/background.
Details:
This is an unpaid internship, although college credit is available.
Start Date:
New programs begin every month, you choose the month you wish to start.
About the Role
The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.
Responsibilities
- Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
- Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
- Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
- Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
- Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
- Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
- Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.
Required Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
- 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
- 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
- Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
- Proven experience tracking testing deliverables, coordinating QC schedules
Preferred Skills
- Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
- Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.
Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.
Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.
What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.
Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.
Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.
Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.
Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.
Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.
Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.
Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.
Specific options depend on the Sailor's status, training, and current Navy policy.
Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.
Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.
Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.
Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.
Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.
It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.
Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.
Take Your Environmental Career to the Next Level
Kleinfelder, a Forbes' Top Employer for Engineers in North America, is committed to a people-first culture, technical excellence, and creating opportunities where employees can thrive!
Are you ready to be challenged, make a difference, and experience professional growth in your career? Kleinfelder's Environmental team is looking for you! From environmental planning, permitting, remediation, and site characterization to chemical data management and hydrogeology, Kleinfelder offers a variety of services designed to provide technically appropriate and cost-effective solutions.
Step into Your New Role
As a Senior Civil / Environmental Engineer, you will work with our civil/environmental team performing technical evaluations, planning, design, and construction administration. This role will help lead, inspire, and support our civil and environmental disciplines, and most importantly help grow our portfolio of work with clients across multiple geographies, but primarily based in New Jersey.
This position is remote and will require approximately 40% travel to project sites primarily in New Jersey and other sites across the country.
Responsibilities:
- Strong experience with the design and construction of civil and/or environmental remediation projects.
- Leading technical efforts for planning, studies, budgeting, project cost estimating, technical management, coordination of multi-disciplinary engineering efforts, quality assurance, subcontract management and contract administration.
- Supervising staff and subcontractors to successfully deliver technical projects and build/mentor staff in the group.
- Ability to effectively communicate design concepts to clients, participating in project scoping activities and proposal presentations, and coordinating with clients to ensure an ongoing positive relationship.
- Establishing strong, productive internal collaborative relationships with senior management.
Qualifications:
- B.S. in civil, environmental, or chemical engineering.
- 12 + years of experience providing technical management of civil / environmental projects.
- Professional Engineering license with ability to obtain New Jersey license within 6 months of start date, if necessary.
- In-depth knowledge of large/complex civil/environmental projects and experience coordinating the various engineering disciplines for successful project completion.
- A strong work ethic with excellent organizational, communication, computer and technical writing skills.
- Strong team building and communications skills.
- Solid written and verbal fluency in English.
- Willingness to travel out of state.
- AutoCAD and Civil 3D experience preferred.
Move Forward with Kleinfelder
Kleinfelder has been connecting great people to the best work since 1961. We are engineers, scientists, and construction professionals providing solutions that improve our clients' transportation, water, energy, and other private infrastructure. As a responsive, cross-disciplinary team of bright, curious, and innovative problem-solvers, we are dedicated to doing the right thing, every day, on every project from over 85 offices in the US, Canada, and Australia. Connecting great people to the best work is our purpose - together, we deliver.
Progress with an Employer that Values You
Kleinfelder is an inclusive organization free from discrimination. We are a stronger organization when we are a diverse workforce and believe that throughdiversity, equity, and inclusion comes creativity, innovation, and unity. We are proud to offer the following:
Benefits: Kleinfelder offers an excellent compensation and benefits package, including medical, dental, vision, life insurance, 401(k) plan, and paid holidays.
New Jersey: The expected salary range for the position is displayed in accordance with the New Jersey Wage Transparency Law. Final agreed upon compensation is based upon individual qualifications and experience. Salary range: $131,000-$182,000.
Career Development: We are committed to investing in the professional development of our staff, offering each employee every opportunity to grow, develop, and take control of their career paths. We support these efforts through reimbursements for continuing education as well as many of the expenses associated with trainings and certifications, and opportunities for career development through our internal Mentoring Program.
Equal Opportunity: Kleinfelder is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans. (Compliant with the new VEVRAA and Section 503 rules)
NOTICE TO THIRD PARTY AGENCIES
Please note that Kleinfelder does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Fee Agreement, Kleinfelder will not consider or agree to payment for any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Kleinfelder explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resume, including those submitted to hiring managers, are deemed to be the property of Kleinfelder.
About Made Scientific
Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.
Position Summary
The Inspection Readiness Lead (Associate Director) is a quality leader responsible for establishing, maintaining, and continuously improving a state of inspection readiness across GMP cell therapy operations, spanning clinical through commercial stages. Reporting to the VP of Quality and Compliance, this individual partners closely with the Site Quality & GMP Compliance Lead and key cross-functional stakeholders to ensure GMP alignment, consistent execution, and inspection readiness across regulatory interactions.
Key Responsibilities
Inspection Readiness & Regulatory Compliance
• Design, implement, and sustain an inspection readiness program supporting clinical and commercial cell therapy manufacturing.
• Maintain a continuous state of readiness for FDA, EMA, and other global health authority inspections, as well as client audits.
• Ensure alignment with applicable regulations, including 21 CFR Parts 210/211, 1271, EU GMP (Annex 1 & 2), ICH guidelines, and global regulatory expectations for advanced therapies.
• Collaborate with Regulatory Affairs and the PMO to translate evolving regulatory and client expectations into actionable inspection readiness strategies, standards, and best practices.
Regulatory Inspections, Client Audits & Customer Assessments
• Serve as the front-room inspection lead for regulatory authority inspections and client audits.
• Lead and coordinate inspection and audit readiness activities, including mock inspections, readiness assessments, gap analyses, and SME coaching.
• Coordinate execution of inspections and audits, including inspection teams, war room operations, daily briefings, issue tracking, and executive updates.
• Lead the development and execution of inspection and audit responses, including FDA 483 observations, regulatory commitments, and client responses, ensuring consistency.
Quality Systems Interface & Continuous Improvement
• Partner with Quality Systems, Site Quality, and Technical Operations teams to ensure audit-ready performance.
• Analyze inspection and audit trends to identify systemic compliance risks and drive remediation and continuous improvement.
• Support inspection readiness for new site start-ups, facility expansions, technology transfers, and commercial launches.
Leadership, Influence & Collaboration
• Provide functional leadership and mentoring on inspection readiness to SMEs and site quality partners, fostering a culture of proactive compliance and inspection confidence.
• Align and influence stakeholders across Quality, Technical Operations, MSAT, Regulatory Affairs, and Program Management to drive inspection readiness initiatives.
• Serve as a trusted advisor to senior leadership on inspection risk, regulatory exposure, and readiness status.
• Champion a strong culture of quality and compliance, reinforcing consistent behaviors, decision-making, and regulatory interactions during audits and inspections.
Required Qualifications
• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• 10+ years of progressive quality leadership experience in cell therapy, biotech, or biologics, with deep exposure to GMP operations.
• Strong expertise in cell therapy or ATMP manufacturing and in-depth knowledge of global GMP regulations (FDA, EMA, ICH, ROW).
• Proven track record in a CDMO environment managing multiple client programs and regulatory compliance requirements.
• Demonstrated leadership during regulatory inspections, including FDA inspections and 483 resolution.
• Excellent verbal and written communication skills, with the ability to articulate complex compliance topics to inspectors, clients, and executive leadership.
• Experience leading audit and inspection planning, execution, and response activities.
• Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as needed.
• Strong organizational skills with the ability to prioritize and manage multiple demands while maintaining a solution-oriented mindset.
Preferred Qualifications
• Experience supporting multiple clients simultaneously within a CDMO.
• Direct experience with pre-approval inspections (PAIs), BLA/MAA readiness, or commercial launch inspections.
• Experience supporting rapid-growth organizations, new site start-ups, or late-stage to commercial transitions.
• Lean, Six Sigma, or quality excellence certifications.
Educational Requirement
• B.S. in Life Sciences, Engineering, or related discipline required; advanced degree preferred.
Physical Requirements
• Ability to perform essential job functions in compliance with company standards, including productivity and attendance.
• Willingness to work in various controlled environments, including CNC/ISO7–8 cleanrooms.
• Ability to lift up to 25 lbs and perform physical tasks such as bending, standing, and working with cell-based products or chemicals.
• Must be flexible and adaptable to changing priorities and dynamic environments.
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.
We are seeking individuals to review and provide feedback on everyday money-management tips. This role focuses on common financial challenges such as managing expenses, reducing spending, and making smarter financial choices.
You will review examples of budgeting methods and evaluate practical ideas people use to stretch their income. The goal is to understand which approaches work best for real households.
The work is flexible and fully online. Applicants should have an interest in budgeting, saving money, or improving financial habits.
No formal finance background is required.
Remote working/work at home options are available for this role.