Project Engineer (Sterile/ Aseptic Facilities)

Kelly Services; Branchburg Township (NJ); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Telemedicine

Term life

Whole life

Accident insurance

Critical illness

Legal plan

Short-term disability

Retirement savings plan

Service bonus

Holiday pay plans

Transit spending account

Paid sick leave

Job summary

Kelly Services is sourcing a Project Engineer for a sterile/aseptic manufacturing facility in Branchburg, NJ. The role focuses on greenfield design, startup, and long-term operation of advanced sterile production infrastructure to support patient-safety and regulatory compliance.

The ideal candidate brings hands-on experience with cleanrooms, utilities, and environmental controls, and can interface across Validation, Quality, and Operations to ensure compliant installations and ongoing

Qualifications

• Bachelor’s degree or higher in an engineering discipline as listed.
• Sterile or aseptic processing experience required or highly desirable.
• Solid understanding of FDA cGMP/GMP regulations, USP standards, and EH&S requirements.
• Direct experience with greenfield facility construction, commissioning, and qualification is highly desirable.

Responsibilities

• Lead design review, specification development, and technical oversight of facility infrastructure systems (cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam).
• Develop and maintain facility engineering standards and documentation aligned to regulatory requirements.
• Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems.
• Collaborate with Validation, Quality, and Operations to ensure IQ/OQ/PQ and environmental monitoring readiness.
• Promote safety and perform risk assessments for engineering activities.
• Establish preventive maintenance programs and calibration schedules for facility reliability.
• Provide technical expertise for deviation investigations, CAPAs, and regulatory inspections.

Skills

Sterile processing

Aseptic manufacturing

HVAC systems

Facility infrastructure

Project management

Cross-functional collaboration

Regulatory compliance

Troubleshooting

Education

Bachelor’s degree in Mechanical, Electrical, Industrial, Chemical or Facilities-related Engineering

Job description

Project Engineer - Sterile / Aseptic Manufacturing

Our client is currently looking for an experienced engineer to help them continue to grow. They have had incredible success as a start up, but need more engineers to optimize existing systems and participate in future facility and processing expansions. We need the candidates to have sterile or aseptic processing experience.

Company & Site Overview:

At the Branchburg, New Jersey manufacturing facility, mission is to establish a state-of-the-art pharmaceutical manufacturing plant dedicated to producing high-quality, sterile injectable IV bag specialty products, with an unwavering commitment to patient safety and care. As a patient-oriented and rapidly growing organization, focus is on delivering specialty, value-added sterile injectables that bridge critical gaps in the market by supporting healthcare workers through improved hospital workflows, reduced waste of key resources, and increased operational efficiencies. This facility marks the foundation of our broader vision to become a trusted leader in sterile manufacturing, with plans to swiftly expand our innovative product portfolio to address evolving healthcare needs.

The Process Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a "state of the art" sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing. This role will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.

Key Responsibilities:

• Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.
• Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.
• Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.
• Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.
• Promote and ensure adherence to safety protocols and safe work practices.
• Perform risk assessments for engineering and maintenance activities.
• Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.
• Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.
• Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.
• Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services.
• Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.
• Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.

Qualifications / Experience:

• Bachelor’s degree in Mechanical, Electrical, Industrial, Chemical or Facilities-related Engineering.
• Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.
• Sterile or aseptic processing experience. Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.
• Solid understanding of FDA cGMP/GMP regulations, USP standards, and applicable environmental, health, and safety requirements.

Skills / Competencies:

• Experience in facility system design, commissioning, and lifecycle maintenance.
• Strong project management and contractor/vendor coordination capabilities.
• Excellent problem-solving and root cause analysis skills.
• Strong understanding of aseptic manufacturing facility requirements and environmental controls.
• Effective communication and cross-functional collaboration skills.
• High attention to detail, safety, and compliance.
• Ability to thrive in a dynamic greenfield/startup environment.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

• medical
• dental
• vision
• telemedicine
• term life
• whole life
• accident insurance
• critical illness
• a legal plan
• short-term disability
• retirement savings plan
• service bonus
• holiday pay plans (earn up to eight paid holidays per benefit year)
• transit spending account
• paid sick leave under the applicable state or local plan

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to the application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.