SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Validation Engineer III (CSV/Automation) to join our client's Medical Device manufacturing team in West Valley City, Utah.

*W2 contract only

MUST HAVES:

• Bachelor's degree in engineering, Life Sciences, or related discipline.
• 7+ years of validation experience in the pharmaceutical or biotech industry
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements
• Knowledge in Organizational Excellence and Lean/Six Sigma
• Knowledge of cost control, and development of guidelines, trainings, and maintenance programs
• Must have a thorough understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools and documentation)
• Must be able to analyze test strategies, develop test plans and execution documents, and review customer deliverables
• Must have a strong knowledge and understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others). Must be able to generate Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix and validation protocols (IQ/OQ/PQ).
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.

JOB RESPONSIBILITIES:

• Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team
• Participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management
• Generation of validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports.
• Review and approve validations and completion reports for new and existing computer and automation systems
• Troubleshooting computer and automation systems that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs
• Work with new and existing manufacturing and laboratory equipment, processes, utilities and facilities with computer or automation systems

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.