Job Title:

Associate Engineer, Validation Location:

Cranbury, NJ Job Summary The Associate Validation Engineer supports the successful operation of facility, laboratory, cGMP Manufacturing and business functions at the Cranbury NJ site through interaction with internal customers and external service providers. The incumbent in this role, will provide support to the US F&E department to ensure that it's compliant with technical documents and validated/qualified equipment. This individual works independently or in teams under the direction of their management to complete assignments. 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. Working with specialized qualification/validation equipment; examples being: Kaye Validator (or similar), clamp meter, RTD probe. Executes qualification and/or validation of equipment, process control systems validation (CSV), cleaning validation, and process validation from implementation through to operational use or execution. ValidationTechnical writer/reviewer of validation plans, qualification protocols, associated reports and procedures. Participates in the re-qualification activities of qualified systems to maintain qualified equipment systems in compliance. Supports facilities new construction and relocation projects. Promotes and provides excellent customer service and support Maintains a positive relationship and work collaboratively with all the members of the US Facility & Engineering Department and site customers while promoting a positive team environment. Ensure equipment, facilities and programs are maintained in compliance. Estimated 10% travel annually based on

US F & E

project needs. 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, Science related discipline, equivalent industry experience, or a combination of experience and education. Experience in FDA-regulated industry (or similar) or experience in equipment commissioning, qualification, and/or validation is a plus. Understanding of 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. Understanding of working in a regulated environment, or understanding of c

GMP, 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 and understanding technical documents Strong multi ‐ tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor Salary range for this role is 54,700-87,500 The job description does not intend to list all the duties and responsibilities assigned to this position. 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