Validation Engineer II

Piper Companies is seeking an experienced Validation Engineer II to support a highly reputable Pharmaceutical company in Lynwood, California.

Responsibilities:

• Responsible for risk analysis, packaging validation, cleaning validation, and equipment qualification required for new products, processes, and equipment and any changes to existing products, processes, and equipment.
• Provide recommendations for product disposition or other actions related to product and equipment performance issues.
• Provide technical decision-making regarding validation strategies and requirements for projects.
• Prepares and reviews all protocols and reports for validation work.
• Coordinates all validation activities by constant communication with affected departments and personnel.
• Scheduling and execution of activities regarding validation projects during all three shifts.
• Execute, oversee, and review validation area processes and procedures.
• Controls and organizes all validation documents.
• Create and/or update intra and interdepartmental procedures, policies, and supporting documentation
• Participate in project meetings.
• Provide weekly updates to the Corporate Validation Manager.
• Strong competency with GMP's concepts, practices, and procedures as defined in 21 CFR Parts 11, 210, 211, and food industry regulations 110, 114, and 117.
• Interface with Regulatory Authorities as required for facility inspections.

Qualifications:

• Bachelor's in chemical or Biological Sciences/Engineering required.
• 7+ years of experience with packaging, cleaning, and equipment validation - Liquids are a plus
  • Liquids pharmaceutical are a plus
  • Batching bulk products in large gallon vessels
• Excellent working knowledge of the FDA Guidance for Industry Process Validation: General Principles and Practices.
• Excellent technical writing skills and strong attention to detail are required.
• Excellent verbal and written communication skills.
• Must be proficient in Office 365 Applications (Word, Excel, Outlook, OneNote, PowerPoint).
• Oracle and QMS experience preferred.
• Must have prior knowledge of instrumentation used in qualification activities.
• Excellent time management and ability to handle multiple tasks simultaneously.

Other notes:

Must be able to wear proper gowning and PPE in production or other designated areas, as required, to meet GMP and/or OSHA requirements.

Must follow all safety requirements applicable to the area/task and all OSHA regulations and company safety policies and procedures.

The position is exposed to a variety of environments, such as the office, laboratory, outside facility, compounding suites, and plant production floor.

Compensation:

• Salary Range: $85,000 - $95,000
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

This job opens for applications on 5/15/2025.Applications for this job will be accepted for at least 30 days from the posting date.

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