**Description:** Senior Engineer with experience in the FDA regulated industry. Proven experience in computer system validation (CSV), data integrity, qualification of automated manufacturing, testing, vision inspection systems, and packaging equipment. Experienced in an automated PC/HMI/PLC based case packaging manufacturing system, and related packaging/ serialization equipment on highly automated syringes packaging line. Developed validation documentation for a fully automated steam sterilization trace and track system. Resource will be working in the OCR/OCV automation project under CapEx 4077. Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team. Actively 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. Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. 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. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation. Analyzes the results of testing and determines the acceptability of results against predetermined criteria. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Manages and supervises the installation of equipment and controls/software modifications for automated equipment. Assists with vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, set-up, training, start-up, and troubleshooting. Lead process improvement projects to improve the validation of computerized systems. Oversee validation contractor resources. Generate and report metrics to monitor the performance of Validation System. Prepare information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary. Qualifications: Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma is preferred. Strong Project Management skills is preferred. Knowledge of cost control, and development of guidelines, trainings, and maintenance programs is preferred. Must have an 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). Have an understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others). Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically. Teamwork oriented and self-starter. 0-3 years of experience. Bachelors Degree is required **Pay Details:** $21.39 to $35.65 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance