Process Equipment and Reliability Engineer

Job Title - Process Equipment and Reliability Engineer

Location - Cranbury NJ

Job Summary

The Process Equipment and Reliability Engineer will provide technical support to ensure safe, reliable, and compliant operation of process and utility equipment within a biopharmaceutical manufacturing facility. An Engineer I will assist with troubleshooting, preventive maintenance, and reliability initiatives while working within cGMP requirements, engineering systems, and reliability methodologies. This role is designed to build foundational skills in equipment engineering and reliability while contributing to daily operations and long-term asset improvement efforts.

Job Responsibilities

Equipment Reliability & Support

• Assist in monitoring equipment performance and identifying potential reliability risks.
• Support troubleshooting activities for processing and utility equipment under guidance from senior engineers.
• Participate in root cause investigations and contribute to corrective and preventive actions (CAPA).
• Collect and analyze basic equipment data (e.g., downtime, work orders, maintenance history) to support reliability assessments.

Maintenance & Asset Management

• Support the execution of preventive and predictive maintenance programs.
• Assist in updating and maintaining accurate equipment records in the CMMS system.
• Help develop and revise maintenance procedures, work instructions, and SOPs.
• Learn and apply reliability tools such as 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

• Ensure all work is completed in accordance with cGMP, FDA, EMA, and internal quality requirements.
• Draft, revise, and review technical documentation (SOPs, equipment logs, reports) under supervision.
• Support preparation for audits and inspections by providing accurate documentation and technical input.

Continuous Learning & Improvement

• Participate in training programs to develop knowledge of biopharma manufacturing equipment, reliability principles, and regulatory compliance.
• Contribute to continuous improvement projects focused on reducing downtime, improving equipment performance, and increasing operational efficiency.
• Collaborate with cross-functional teams to learn best practices and support improvement initiatives.

Qualifications

• Bachelor’s degree in mechanical, Chemical, Bioprocess, or related Engineering discipline.
• 2 years of engineering experience; internship or co-op in pharmaceutical, biotech, or regulated manufacturing environment preferred.
• Basic understanding of process equipment and maintenance concepts.
• Strong problem-solving and analytical skills with eagerness to learn reliability engineering practices.
• Ability to work effectively in a team environment and communicate technical information clearly.
• Familiarity with cGMP or other regulated manufacturing environments is a plus.
• Proficiency with Microsoft Office tools; exposure to CMMS or data analysis software is desirable.
• Experience with CMMS systems, asset management practices, and data-driven decision-making.
• Must work in a self-motivated, highly flexible, well-organized, and detail-oriented style with the requirement of some evening conference call time and occasional local or international travel.
• Must be able to wear appropriate PPE, ability to stand /sit/walk for long periods of time, ability to lift 50 lbs. occasionally.

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.