Senior Engineer , Validation

Position: Senior Engineer I, Validation (5406)
Location: Cranbury

Job Title - Senior Engineer l, Validation

Work Location - Cranbury NJ

Job Summary

The Senior Validation Engineer supports the successful operation of facility, laboratory, cGMP Manufacturing and business functions at WuXi Biologics sitesthoughout the United States through interaction with internal customers and external service providers. The incumbent in this role, executes projects or programs put in place to address validation requirements and issues. This individual works independently or in teams under the direction of their management to complete assignments.

Using solid analytical skills, the incumbent is able to complete their tasks and recognize problems and develop possible solutions of correction to recommend to management. This individual will participate in the work group on multi-disciplinary and cross-functional teams and uses established relationships to contribute to teams and stakeholders with fact-based, business value knowledge.

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).

* 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, 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 21

CFR 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

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

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.