Validation Resource

Position: Validation Resource Location: Los Angeles, CA (On-Site 3 days/week) Length: 3+ Month Contract Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available. Job Description: We are seeking an experienced MES Validation Resource with expertise in Siemens Opcenter to support validation activities within a regulated biotech/pharmaceutical manufacturing environment. The ideal candidate will have a strong background in Computerized System Validation (CSV), with a proven track record of testing MES applications in compliance with FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements. Essential Duties and Responsibilities: • Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in GMP environment. • Analysis of complex manufacturing business processes and identify, evaluate, develop and/or redesign systems, processes, and procedures to meet user requirements on large initiatives. • Review and update user requirements and functional specifications. • Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills. • Participate and work closely with cross-functional team members (Engineering, Manufacturing, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to develop the validation strategy and system validation requirements based on concepts of risk-based CQV which includes user requirements, functional specifications, design specifications, commissioning and validation. Emphasis is following regulatory guidelines and industry standards. • Execute protocols, write reports, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate. • Validate interface data transfer between integrated systems to ensure data integrity, traceability, and proper system data retrieval • Maintain accurate validation records and documentation (including validation plans, functional specifications, protocols, and SOPs) to support compliance, audits, and inspections in GMP environments. • Maintain accurate and complete records of validation and testing activities to support audits and inspections. • Identify, log, and track software defects and discrepancies. Collaborate with development and quality validation teams to troubleshoot and resolve issues. • Lead and coordinate validation assignments, demonstrating strong organizational and planning skills while shaping validation strategies based on risk-based CQV principles. • Continuously recommend and implement improvements to validation methods, tools, and documentation standards to drive efficiency and maintain compliance. • Ability to present a course of action to management and project team using both written and verbal communication tools. Qualifications: • Must have experience in pharmaceutical/biotech validation which includes the writing and executing of protocols and standard operating procedures. • Bachelor's degree in engineering discipline required. 7+ years of related experience working knowledge of in system testing, quality assurance, or computerized system validation (CSV), testing concepts, verification, and validation techniques, defect management, and risk management Experience in manufacturing processes and control systems. • Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all validation elements. • Ability to write and speak in the English Language. • Proficient in writing test cases, test scripts, and validation documentation. • Experience with test management and defect tracking tools (e.g., Jira, TestRail, HP ALM). • Experience with Siemens OpCenter • Familiarity with both manual testing and exposure to automated testing tools is a plus. • Understanding of system development life cycle (SDLC) and Agile/Waterfall methodologies. • Excellent oral and written communications skills, business acumen with analytical, critical thinking and problem-solving skills. • High attention to detail and ability to follow procedures precisely. • Ability to manage multiple priorities in a fast-paced, regulated environment. • Knowledge of 21 CFR Part 11 or other industry-specific validation guidelines. • Experience with risk-based validation approaches. • Exposure to enterprise systems such as ERP, LIMS, DeltaV, OSIPI or other business-critical applications. • Strong communication and interpersonal skills. Ability to work & influence effectively in a cross functional setting. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. Come see why DPC has achieved: • 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor. • Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine. 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