Engineering Jobs in Cranbury

Title

Electrical Controls Engineer/Industrial Electrician

Report to

Facility/Engineering Director.

Job Summary

Individual must be able to perform design,engineering, and field start up responsibilities for System Integration in the Electrical Controls Industry. In addition, proven trouble

shooting skills are necessary.

Job Duties / Responsibilities

• Design, fabricate, and install PLC based process control panels.
• Troubleshoot and upgrade existing control panels.
• Maintain inventory of all PLC/HMIrack systems and programs.
• Work to install110V, 220V, and 480V 3 phase wiring.
• Real electrical schematics and wiring diagrams.
• Be able to troubleshoot 480V electrical control systems.
• Specify wiring and motor controls for 480V systems.
• Install power distribution and protection systems.
• HMI Interfaces
• Temperature Controllers and Transmitters
• Pressure Transmitters
• 4-20ma Loop Controllers
• Burner Controllers and Actuators
• Industrial pH Meters
• Level Transmitters
• Flow Meters
• Variable Frequency Drives

Work Conditions

• Physically available to lift up to 50lb.
• Exposure to hazardous conditions associated with the Company
• 24/7 availability may be required.
• Manual dexterity and the ability to remain standing, crouching, and bending for long periods of time
• Overtime as needed.

Job Requirements

• AS, BSEE, BSEET, or technical degree.
• 3-5 years of industry experience.
• Review projects including quotes, job specifications, and resolve any quote to job specifications differences.
• System Architecture including non-standard material and control pane lpower requirements/distribution.
• Review specifications and standard practices – inclusive of the internal hardwired and logic standards, general specifications and scope of work.
• Design requirements which include establishing non-standard designs, generating system map layouts, generating a sequence of operations, reviewing cycle time

studies and dimension switch layouts, generation of design packages, design logic, enter logic, and the design of Smart Displays.

• Material responsibility includes advance material order, specifying Mod Box material, specifying Panel material, writing Mod Box EBMs and writing panel material EBMs.
• Assisting with installation • Debugging with no additional support • Launchand Standby
• As Builts

Technology Requirements

• RSLogix 5, 5000
• RS Networx for DeviceNet, ControlNet, EtherNet IP
• DriveExecutive, DriveExplorer

• PanelBuilder PDS, 1400e, 32
• RSView Studio
• Trouble Shooting PID Loops
• Calibrating Process Control Equipment
• Microsoft Office Suite

Benefits

• Competitive Compensation

- 401(k)

• 401(k) Matching
• Medical, Dental,and Vision Benefits
• Paid Time Off and Paid Holiday’s

Classification

Full Time Position

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 Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.

Key Responsibilities

• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.

• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.

• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.

• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.

• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.

• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.

• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.

• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.

• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.

• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.

• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.

Leadership & People Management

• Mentor and coach team members to continually develop and enhance their skills.

• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.

• Foster a culture of accountability with progressive empowerment and ownership.

• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.

• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.

• Experience hosting and managing regulatory and client inspections.

• Strong understanding of Quality Systems requirements and regulatory expectations.

• Excellent oral and written communication, listening, and problem-solving skills.

• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.

• Strong organizational awareness with significant experience working cross-functionally.

• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.

• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.

• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.

• Proven experience influencing stakeholders across a broad spectrum of GxP topics.

• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.

Preferred Qualifications

• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.

• Experience with cell and gene therapy manufacturing in clinical or commercial environments.

• Strong track record managing quality systems and training programs.

• Expertise in aseptic manufacturing processes.

• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.

• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.

Required Degree

• B.S. in a relevant scientific discipline (advanced degree preferred).

Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.

Company Description

CCL Industries is a global leader in specialty packaging & Labeling solutions, offering a wide range of innovative products. These include extruded and laminated plastic tubes, folded instructional leaflets, and precision-printed components with LED displays, among others. CCL also operates Avery, the world's largest supplier of labels, specialty media, and software for short-run digital printing. Additionally, the company includes CCL Container, a top producer of aluminum aerosol cans and bottles for consumer packaged goods in the United States. With its diversified product portfolio, CCL serves a variety of end-use markets worldwide.

Role Description

This is a full-time on-site role for a Production Supervisor - Labeling & Packaging, based in Hightstown, NJ. The Production Supervisor will oversee and coordinate labeling and packaging operations to ensure efficient workflows. Responsibilities include managing production schedules, overseeing production planning, and ensuring quality standards are consistently met. The role involves directing and supporting production staff, addressing any operational issues, and adhering to safety protocols within the facility.

Essential Functions

• Oversees daily production operations to ensure scheduled jobs are completed safely, accurately, and on time.
• Leads, trains, and supports production staff, promoting teamwork, efficiency, and adherence to company policies.
• Monitors production equipment and workflows to maintain quality standards and minimize downtime.
• Ensures compliance with safety regulations, cGMP, and operational procedures at all times.
• Coordinates material needs, machine setups, and job changeovers to maintain continuous production flow.
• Troubleshoots production issues and implements corrective actions to improve performance and reduce waste.
• Tracks and reports production metrics, including output, quality, waste, and labor utilization.
• Communicates effectively with leadership, quality, logistics, and other departments to support overall plant operations.
• Supports continuous improvement initiatives, including Lean, 5S, and process optimization efforts.

Qualifications

• Flexographic printing experience is strongly preferred for this role.
• Strong Supervisory Skills, including team leadership and employee development
• Experience in Production Planning and Production Schedules to manage efficient workflows
• Competency in Production Management practices to ensure operational efficiency and quality
• Excellent Communication skills, including the ability to provide clear direction and foster collaboration
• Knowledge of safety procedures and guidelines in a packaging or manufacturing environment
• Problem-solving and organizational skills to manage multiple priorities effectively
• Previous experience in labeling or packaging industries is a plus
• Associate or Bachelor’s degree in Engineering, Management, or a related field is preferred

Skills/Aptitudes:

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. 
• Ability to write routine reports and correspondence.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Skill in operating computer systems with a proficiency in Word/Excel and ability to learn AS400.
• Ability to speak effectively and present information in one-on-one and small group situations to customers, vendors, and other employees of the organization.
• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.

Compensation: $80,000 – $93,000 per year

Schedule: Monday-Friday: 2nd shift (3:00pm-11:00pm) or 3rd shift (11:00pm-7:00am)

Working Conditions/Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and ink vapors. The noise level is usually loud.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects or operate pressroom equipment and tools, reach with hands and arms, talk and hear, and lift at least 50 lbs.

Specific vision abilities required by this job include close vision, distance vision, color-vision, peripheral vision, depth perception, and ability to adjust focus.

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.

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.