Senior Engineer I, Validation

Job 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).
• Assists 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, reugulatory audits, and initial/routine audits (internal and external by partners/potential partners).

Qualifications

• BS in Engineering or Science related discipline or equivalent industry experience. preferred.
• Minimum of 8 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.
• Experience in the qualification of biologics equipment a plus.
• 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

Pay

The anticipated salary range for this position is $73,000 - $117,000