WuXi Biologics · 9 hours ago
Principal Validation Engineer
Cranbury, NJ
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expWuXi Biologics is a leading global contract biologics organization, and they are seeking a Senior Validation Engineer to support the successful operation of their facility and laboratory functions. The role involves executing validation projects, maintaining compliance across multiple sites, and collaborating with internal and external stakeholders.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Maintains all qualified equipment systems in compliance with policies, guidelines and procedures across multiple sites within the WuXi Biologics United States network, including, but not limited too; Cranbury (NJ), Robbinsville (NJ), and Wocester (MA)
Experience with specialized qualification/validation equipment; examples being: Kaye Validator (or similar), clamp meter, RTD probe, etc
Supervise & trains junior personnel. commissioning/qualification/validation activities
Contributes or initiates/authors change controls, validation plans, qualification protocols, associated reports and procedures
Authors, reviews, and/or executes qualification and validation protocols
Executes qualification and/or validation of equipment, process control systems validation (CSV), cleaning validation/verification, shipping validation, and process validation from implementation through to operational use or execution
Performs periodic field review, and re-qualification of qualified systems
Participate with investigations into qualification failures, and assists with remediation plans including deviations and CAPAs associated with qualified/validated systems and equipment
Contributes to reviews and/or revision of written procedures (SOP)
Assist or lead in equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
Provides assistance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates
Supports facilities new construction and relocation projects
Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to WuXi standards
Promotes and provides excellent customer service and support
Maintains a positive relationship and work collaboratively with all the members of the Facility & Engineering Department and site customers while promoting a positive team environment
Ensure equipment, facilities and programs are maintained in compliance
Responsible to contribute in the preparation for regulatory inspection readiness, regulatory audits, and initial/routine audits (internal and external by partners/potential partners)
Qualification
Required
Minimum of 5 years' experience in FDA-regulated industry (or similar) with 3 years experience in commissioning, validation, and qualification
Experience in risk mitigation, complex problem solving, and troubleshooting to achieve cGMP production operation success
Excellent communications skills
Great team player and ability to collaborate with internal stakeholders, vendors and clients to achieve alignment and work effectively
Must work in a self-motivated, highly flexible, well-organized and detailed-oriented style with requirement of some evening conference call time
Must be able to wear appropriate PPE, ability to stand /Sit/walk for long periods of time, ability to Lift 50 lbs. occasionally
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
Strong written and verbal communication skills
Experience writing, executing, and reviewing equipment qualification documents
Strong multi‐tasking ability in conjunction with proven organizational skills
Ability to organize assigned tasks in a high paced environment and concurrently monitor
Preferred
BS in Engineering or Science related discipline or equivalent industry experience
Experience in the qualification of biologics equipment a plus
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
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