Validation Engineer II at Jobot
Lynwood, CA 90262
About the Job
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 "Quick 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?
Job Details
JOB QUALIFICATIONS:
POSITION RESPONSIBILITIES:
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Gabriel Ozuna
Are you a fit? Easy Apply now by clicking the "Quick 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 "Quick Apply" button.
Salary
85,000 - 100,000 /year