WuXi Biologics
Process Equipment and Reliability Engineer I
WuXi Biologics, Cranbury, New Jersey, United States
Process Equipment and Reliability Engineer I
Job Title: Process Equipment and Reliability Engineer I Location: Cranbury, NJ WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Job Summary:
The Process Equipment and Reliability Engineer I 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. Responsibilities: 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. 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). 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. 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. Requirements: Bachelor’s degree in mechanical, chemical, bioprocess, or related engineering discipline. 0–2 years of engineering experience; internship or co-op in pharmaceutical, biotech, or regulated manufacturing environment preferred. Self-motivated, highly flexible, well-organized, and detail-oriented with some evening conference call time and occasional local or international travel. Ability to wear appropriate PPE, stand/sit/walk for long periods, and lift up to 50 lbs occasionally. 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 and communicate technical information clearly. Familiarity with cGMP or other regulated manufacturing environments is a plus. Proficiency with Microsoft Office; exposure to CMMS or data analysis software is desirable. Experience with CMMS systems, asset management practices, and data-driven decision-making is a plus. 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. WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Job Title: Process Equipment and Reliability Engineer I Location: Cranbury, NJ WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Job Summary:
The Process Equipment and Reliability Engineer I 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. Responsibilities: 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. 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). 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. 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. Requirements: Bachelor’s degree in mechanical, chemical, bioprocess, or related engineering discipline. 0–2 years of engineering experience; internship or co-op in pharmaceutical, biotech, or regulated manufacturing environment preferred. Self-motivated, highly flexible, well-organized, and detail-oriented with some evening conference call time and occasional local or international travel. Ability to wear appropriate PPE, stand/sit/walk for long periods, and lift up to 50 lbs occasionally. 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 and communicate technical information clearly. Familiarity with cGMP or other regulated manufacturing environments is a plus. Proficiency with Microsoft Office; exposure to CMMS or data analysis software is desirable. Experience with CMMS systems, asset management practices, and data-driven decision-making is a plus. 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. WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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