Validation Engineer

Eastridge Workforce Solutions is proud to partner with a leading pharmaceutical company in Lynwood, CA, in its search for a Validation Engineer. This is a direct hire opportunity offering excellent potential for growth. Apply today for immediate consideration!

Job Qualifications:

• Bachelor’s degree in Chemical or Biological Sciences/Engineering required.
• Minimum of 1 year of experience in a similar role within the liquid pharmaceutical industry.
• Strong understanding of FDA Guidance for Industry Process Validation: General Principles and Practices.
• Exceptional technical writing skills with strong attention to detail.
• Excellent verbal and written communication skills.
• Proficiency in Office 365 applications, including Word, Excel, Outlook, OneNote, and PowerPoint.
• Experience with Oracle and Quality Management Systems (QMS) preferred.
• Knowledge of instrumentation used in qualification activities.
• Strong time management skills and the ability to manage multiple tasks simultaneously.
• Self-motivated, well-organized, and able to work independently.
• Experience working on cross-functional projects at various organizational levels.
• Comprehensive understanding of validation methodologies.
• Ability to analyze and propose solutions for process, utility, equipment, and cleaning validation activities.
• Proficiency in Probability Statistics or statistical tools required.
• Ability to thrive in a fast-paced environment while managing shifting priorities.
• In-depth knowledge of Quality Control, Quality Assurance, Engineering, and Regulatory Compliance disciplines.
• Availability to work off-shifts, weekends, and holidays as needed to meet validation project goals.
• Willingness to travel to support validation activities at other organizational sites.

Position Responsibilities:

• Perform risk analysis, packaging validation, cleaning validation, and equipment qualification for new and modified products, processes, and equipment.
• Provide recommendations on product disposition and address equipment performance issues.
• Make technical decisions regarding validation strategies and requirements for projects.
• Prepare and review protocols and reports related to validation activities.
• Coordinate validation efforts through consistent communication with relevant departments and personnel.
• Schedule and oversee validation activities across all three shifts.
• Execute and review processes and procedures in the validation area.
• Maintain organization and control of all validation documentation.
• Develop and revise departmental procedures, policies, and supporting documentation.
• Participate in project meetings and provide updates to the Corporate Validation Manager on a weekly basis.
• Perform additional duties as assigned.
• Demonstrate strong competency in GMP concepts and practices as defined in 21 CFR Parts 11, 210, 211, and food industry regulations 110, 114, and 117.
• Interface with regulatory authorities during facility inspections as required.

Benefits

• 401k, vacation, sick time, holiday pay. Health/ life insurance. 

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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