Validation Engineer at Adecco USA

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

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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