WuXi Biologics · 13 hours ago
Principal Process Equipment and Reliability Engineer
Cranbury, NJ
Full-time
Onsite
Lead/Staff
8+ years expWuXi Biologics is a biopharmaceutical manufacturing company seeking a Principal Process Equipment and Reliability Engineer to serve as the technical leader for equipment reliability and lifecycle management. This role involves developing reliability strategies, guiding a team of engineers, and ensuring the reliable operation of process and utility equipment.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide leadership, direction, and mentorship to a team of reliability engineers and maintenance professionals
Set vision and strategy for the site’s equipment reliability program, aligned with manufacturing goals, compliance standards, and corporate initiatives
Develop and maintain equipment lifecycle management plans, balancing performance, cost, and risk
Represent Reliability Engineering in cross-functional forums, audits, and regulatory inspections
Lead implementation of reliability engineering tools and methodologies (FMEA, RCM, RCFA, Weibull analysis, predictive monitoring)
Establish and track site-level equipment reliability KPIs, driving accountability and continuous improvement
Oversee technical investigations of recurring failures and champion long-term solutions to eliminate systemic issues
Ensure reliability initiatives are aligned with business priorities (production schedule, compliance, cost optimization)
Own the development and optimization of preventive and predictive maintenance programs across the facility
Guide criticality assessments to prioritize assets for reliability improvement focus
Partner with Supply Chain and Maintenance to ensure spare parts strategy, vendor support, and contracts are aligned with reliability goals
Drive adoption of digital and data-driven technologies (e.g., CMMS, condition monitoring, advanced analytics)
Provide technical leadership for troubleshooting and optimization of critical process equipment, including upstream, downstream, and fill/finish systems (e.g., bioreactors, chromatography skids, filtration units, CIP/SIP systems, autoclaves)
Collaborate with Process Engineering, Manufacturing Sciences, and Operations to ensure process-equipment fit and reliability
Support equipment design, procurement, commissioning, qualification, and validation activities for new installations and modifications
Ensure all engineering and reliability activities are compliant with cGMP, FDA, EMA, and other applicable regulatory standards
Author, review, and approve technical documentation, SOPs, maintenance procedures, and engineering reports
Support responses during regulatory inspections and audits related to equipment and reliability
Champion a culture of reliability, safety, and continuous improvement across the site
Train and develop staff on equipment reliability principles, tools, and best practices
Partner with Quality, Manufacturing, and EHS to identify and execute improvement opportunities
Benchmark and adopt industry best practices for biopharma reliability engineering
Qualification
Required
Bachelor's or Master's degree in Mechanical, Chemical, Bioprocess, or related Engineering discipline
8–12+ years of experience in equipment reliability, process engineering, maintenance, and single-use technology within a regulated biopharma/pharmaceutical manufacturing environment
Minimum 1–5 years of demonstrated people-leadership experience (managing engineers, technicians, or cross-functional teams)
Proven experience in risk mitigation planning and ability to solve complex manufacturing process engineering-related problems. Ability to make appropriate judgments and rapidly troubleshoot issues to achieve cGMP production operation success
Strong knowledge of biologics process equipment and cGMP regulatory requirements
Proven success implementing reliability methodologies and maintenance strategies at scale
Excellent leadership, communication, and team development skills
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 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
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
Morningstar.com
2025-12-24
Company data provided by crunchbase