Validation Engineer

Job Title - Validation Engineer

Work Location - Cranbury NJ

Job Summary

The Validation Engineer supports the successful operation of facility, laboratory, cGMP Manufacturing and business functions at the Cranbury and Robbinsville NJ sites 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.

Responsibilities

• Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
• Executes in the field commissioning, qualification, and/or validation (CQV) of equipment, facilities, utilities and instruments.
• Executes specialized CQV. Such as, but not limited to; cleaning validation, shipping validation, environmental sampling.
• Validation Technical 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.
• Authors reviews and/or revises written procedures (SOPs, Protocols, etc.).
• 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, regulatory audits, and initial/routine audits (internal and external by partners/potential partners).

Qualifications

• BS in Engineering, Science related discipline or equivalent industry experience.
• Minimum of 2 years’ experience in FDA-regulated industry (or similar) or 2 years experience in equipment commissioning, qualification, and/or validation.
• Experience with specialized qualification/validation equipment; examples being: Kaye Validator (or similar), clamp meter, RTD probe.
• 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.
• 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 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 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.