Engineering Jobs in Princeton Junction, NJ

Title: Contracts Compliance Manager

Pay: $130,000 – $160,000 base + bonus potential

Location: Hamilton Township, NJ | Fully onsite with up to 25% travel (primarily to east coast HQ and field offices)

Company: Confidential manufacturing subsidiary of a publicly traded clean energy company

About the Role

A newly created, high-visibility opportunity for an experienced Contracts Compliance Manager to lead contract negotiation, administration, and compliance for both commercial and government sectors. This role supports a fast-growing manufacturing site and works cross-functionally with leadership, engineering, finance, and sales to manage contract risk, ensure FAR/DFARS compliance, and support real-time business decisions.

Responsibilities

Contract Management & Negotiation

• Draft, review, and negotiate a wide range of contracts (government, commercial, subcontracts, NDAs, POs, and MSAs).
• Oversee cradle-to-grave contract administration and ensure timely fulfillment of obligations.
• Lead contract negotiations with customers and vendors, balancing business goals with risk mitigation.
• Review RFPs/RFQs to ensure compliance and recommend appropriate risk management terms.

Compliance & Risk Oversight

• Ensure full compliance with FAR/DFARS and other government contracting requirements.
• Maintain alignment with public-company policies and standards.
• Partner with internal teams on audits, reporting, and documentation accuracy.
• Provide training and guidance to stakeholders on contract and compliance requirements.

Cross-Functional Collaboration

• Work closely with the General Manager, Engineering, Sales, and Finance teams.
• Support process improvements, revenue recognition, and operational efficiency initiatives.
• Serve as a subject matter expert on all contract compliance and policy interpretation.

Requirements

• Bachelor’s degree in Business, Legal Studies, Government Contracting, or related field (JD preferred).
• Minimum 5+ years managing both commercial and government contracts in manufacturing, defense, or industrial environments.
• Proven success in managing contracts cradle-to-grave and navigating FAR/DFARS.
• Product-based contract experience required (not software/IP).
• Strong drafting, negotiation, and analytical skills.
• Excellent communication and relationship management abilities.
• Experience with compliance initiatives or process improvement preferred.

Preferred Attributes

• Hands-on, adaptable team player with a proactive mindset.
• Strong business judgment and ability to work independently.
• Comfortable in a fast-paced, evolving environment.
• Sense of humor, accountability, and collaborative spirit highly valued.

Culture & Growth

• Tight-knit, collaborative team where everyone “rolls up their sleeves.”
• Exposure to senior leadership and opportunities to shape policies and processes.
• Onsite culture that values initiative, learning, and cross-functional visibility.
• Long-term stability with the backing of a publicly traded clean energy leader.

About Made Scientific

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

Position Summary

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

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

Key Responsibilities

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

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

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

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

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

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

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

• Perform other duties as assigned.

Required Qualifications

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

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

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

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

• Excellent communication, leadership, and organizational skills.

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

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

Preferred Qualifications

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

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

Physical Requirements

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

• Regular, punctual attendance is required.

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

• Must be able to lift up to 25 lbs.

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

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

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

Work Schedule

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

About 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.

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

With a passion for life

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

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

Job Location: 160 Princeton Hightstown Road, East Windsor NJ 08520

Rate of Pay: Rate of pay: $84,469 - $103,320 per year

Job Overview

The Warehouse Management Systems (WMS) Analyst serves as the on-site liaison between the operations management team and the Information Technology team, and plays a role of a super user in the utilization of the system. They would be responsible for day-to-day system maintenance and troubleshooting. First point of contact for assistance, questions, issues, training others, etc. at the operations level. Work with Operations teams, IT, and Engineering groups to ensure optimal configurations for WMS conversions, enhancements, and new business requirements.

Job Responsibilities and Essential Duties

• 
  
• Conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. Includes program analysts and management consultants.
  
• Serves as the on-site liaison between the Operations Management and Information Technology teams, acting as a super user of the Warehouse Management System (WMS).
  
• Responsible for day-to-day system maintenance and troubleshooting, and functions as the first point of contact for operational-level assistance, including user questions, issues, and training. Collaborates with Operations, IT, and Engineering teams to ensure optimal system configurations for WMS conversions, enhancements, and new business requirements.
  
  

Minimum Requirements

• 
  
• Bachelor's degree in a STEM field plus 3 years of experience in warehouse management systems, or related.
  
• A minimum of 3 years of related systems experience.
  

Required Knowledge, Skills, and Abilities

• 
  
• Requires skills and experience to involve: Expert-level knowledge of Blue Yonder WMS from an operational perspective, including data mining, issue investigation, system adjustments, and development of best practices.
  
• Hands-on experience managing warehouse zones, including movement paths, storage zones, pick zones, and count zones, to ensure efficient workflow and inventory accuracy.
  
• Proven ability to troubleshoot RF (radio frequency) issues, ensuring minimal disruption to daily operations. Expertise in barcode configuration and management, supporting accurate and efficient inbound, picking, and pack-out processes across multiple product lines.
  
• Strong background in waving processes and shortage resolution, critical to ensuring on-time order fulfillment.
  
• Experience testing within Blue Yonder WMS environments, following documentation best practices to ensure system reliability and consistency.
  
• Skilled in troubleshooting support requests related to WMS and integrated systems or interfaces.
  
• Experience developing and maintaining SOPs and site-specific process documentation to ensure consistent and efficient operations.
  
• Familiarity with shipping quality guidelines, and extensive experience in inventory management and quality control to ensure operational excellence.
  

Supervision/Management of Others:

• 
  
• The position does not supervise other employees
  

Internal and External Contacts/Relationships

• 
  
• Internal: Warehouse and Logistics team, Getinge employees
  
• External: Working relationships with external vendors, operations, and IT team members
  

Environmental/Safety/Physical Work Conditions

• 
  
• Ensures environmental consciousness and safe practices are exhibited in decisions
  
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
  
• May work extended hours during peak business cycles
  

Permissions

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

About us

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

At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement

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

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

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.

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.

Company Description

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

Role Description

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

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

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

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

Responsibilities

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

Skills and Experience

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

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

Engineer II – Mid Level (2–5 years)

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

Engineer III – Senior Level (5+ years)

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

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.

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.