Associate Validation Engineer

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
• Maintain 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.

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 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 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

Pay

Salary range for this role is 54,700-87,500