Job Title - Associate Process Equipment and Reliability Engineer
Work Location - Cranbury NJ
Job Summary
The Associate Process Equipment and Reliability Engineer will support the safe, reliable, and compliant operation of process and utility equipment within a biopharmaceutical manufacturing facility. This entry-level position, under the guidance of senior engineers and engineering leadership, provides opportunities to develop foundational knowledge in equipment engineering, maintenance, reliability practices, and cGMP-regulated manufacturing environments. The Associate Engineer will assist with equipment monitoring, maintenance activities, technical documentation, troubleshooting, and continuous improvement initiatives, while building technical competency in biopharmaceutical manufacturing systems and reliability engineering principles.
Job Responsibilities
- Assist in monitoring equipment performance and identifying basic equipment issues or reliability concerns.
- Support troubleshooting activities for process and utility equipment under the direction of senior engineers.
- Participate in equipment investigations and help collect information to support root cause analysis and CAPA activities.
- Gather and organize equipment performance data, maintenance records, and operational metrics.
- Support reliability assessments by maintaining accurate records and reporting equipment observations.
Maintenance & Asset Management
- Assist with preventive maintenance and predictive maintenance program activities.
- Support maintenance planning efforts through data collection and documentation updates.
- Maintain accurate equipment records and documentation within CMMS and asset management systems.
- Assist with development and revision of maintenance procedures, work instructions, and SOPs.
- Learn and apply basic reliability engineering concepts, including Failure Modes and Effects Analysis (FMEA) and Reliability-Centered Maintenance (RCM).
Process Equipment Familiarization
- Gain exposure to upstream, downstream, and fill/finish equipment (e.g., bioreactors, chromatography skids, filtration systems, CIP/SIP systems, autoclaves).
- Work with operations, maintenance, and senior engineers to understand process-equipment interactions.
- Support commissioning, qualification, and validation activities for new or modified equipment as assigned.
Compliance & Documentation
- Develop familiarity with biopharmaceutical manufacturing equipment including upstream, downstream, and fill/finish systems, CIP/SIP systems, autoclaves, and utility equipment.
- Support equipment inspections, maintenance observations, and engineering assessments.
- Work closely with Operations, Maintenance, Validation, Quality, and Engineering teams to understand equipment and process interactions.
- Participate in commissioning, qualification, and validation activities as assigned.
Continuous Learning & Improvement
- Participate in training programs focused on process equipment, reliability engineering, maintenance practices, and regulatory compliance.
- Support continuous improvement projects aimed at improving equipment reliability, reducing downtime, and enhancing operational efficiency.
- Develop technical and professional skills through mentorship and on-the-job learning opportunities.
- Collaborate with cross-functional teams to support operational excellence initiatives.
Qualifications
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Bioprocess Engineering, Electrical Engineering, or related engineering discipline.
- 0–2 years of engineering experience. Internship, co-op, research experience, or exposure to pharmaceutical, biotechnology, manufacturing, or regulated industries is preferred but not required.
- Basic understanding of engineering principles and equipment systems.
- Strong analytical, problem-solving, and organizational skills.
- Demonstrated willingness to learn and develop technical expertise in equipment reliability and maintenance engineering.
- Effective written and verbal communication skills.
- Ability to work collaboratively within cross-functional teams.
- Exposure to CMMS systems, data analysis tools, or reliability methodologies is a plus.
- Familiarity with cGMP or regulated manufacturing environments is desirable but not required.
- Ability to work in a self-motivated, flexible, organized, and detail-oriented manner.
- Must be able to wear required PPE and work safely within manufacturing and utility areas.
- Ability to stand, walk, and sit for extended periods.
- Ability to occasionally lift to 50 pounds.
- Occasional evening conference calls and limited local or international travel may be required.
The anticipated salary range for this position $55,000 - $88,000
The job description does not intend to list all the duties and responsibilities assigned to this position. An employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and the company's business needs.
