Validation Engineer II

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Job details

Validation Engineer Needed - Leading Pharma Manufacturer - Opportunities for growth & advancement

This Jobot Job is hosted by Gabriel Ozuna

Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.

Salary $85,000 - $100,000 per year

A Bit About Us

We are a leading manufacturer and distributor of over the counter pharmaceutical and consumer healthcare products with a commitment to improving peoples lives every day.



Why join us?

• We value our employees and we foster an environment where people are passionate about their work.
• Competitive Pay
• Excellent Benefits
• Stable organization with a national presence
• Opportunities for continued growth & advancement
  
  

Job Details

Job Qualifications

• Bachelor’s in Chemical or Biological Sciences/Engineering required.
• 7 years of experience in a similar liquid pharmaceutical industry role.
• 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.
• Ability to work independently, be self-motivated and organized.
• Ability to work on various projects with cross-functional teams at all organizational levels.
• Strong working knowledge of validation methodology.
• Ability to analyze, investigate, and propose process, utility, equipment, and cleaning approaches and manage associated validation activities.
• Knowledge of Probability Statistics or various statistical tools is required.
• Ability to work in a fast-paced environment while supporting multiple and changing priorities.
• Strong working knowledge of technical disciplines associated with Quality Control, Quality Assurance, Engineering, and Regulatory Compliance.
• Work hours include off-shifts, weekends, and holidays to complete validation project goals.
• Business travel is required to provide Validation support for other sites within the organization.
  
  

Position 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.
• Performs miscellaneous job-related duties as assigned.
• 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.
  
  

Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.

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