Are you looking for a job that will help you assist in ending the COVID-19 pandemic? We have partnered with an industry leading bio-pharmaceutical manufacture that is ramping up production for a Corona Virus vaccine. This Albuquerque, NM based sight is seeking to increase its headcount by 100 individuals over the course of the next year to keep up with production! As a part of the first wave of growth my client is seeking a talented Validation Specialist to join its rapidly expanding team.
The Validation Specialist will have the following responsibilities:
- Writes computer related system validation protocols, manufacturing equipment and master plans and supervises and/or performs testing related to computer related system validation.
- Writes, assesses and summarizes lyophilizer qualification protocols.
- Writes packaging equipment validation protocols and master plans and supervises and/or performs testing related to packaging equipment validation.
- Monitors the qualification and validations process to determine accuracy and reliability of equipment, systems, instruments and processes; and effects repairs/adjustments and changes based on results.
- Analyzes data and writes and/or reviews final reports and summaries for validation protocols.
- Develops, reviews and recommends changes to validation procedures.
- Conducts special projects as directed by management.
- Provides technical advice on new equipment and systems and modification to existing equipment and systems to ensure validation/certification and servicing can be provided.
- Provides technical assistance and training for personnel.
- Schedules validations with section supervisors to ensure timely completion with minimal disruption of production schedule.
- Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to directives and regulations.
- Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.
- Interacts as needed with outside vendors and consultants.
- Other duties may be assigned
The ideal candidate will have the following qualifications:
- At least 4 years of validation experience at sterile cGMP manufacturing facility.
- Experience with computer systems validation
- Bachelor's degree, but open to lower education achieved with additional work experience.
