Cleaning Validation Specialist - bioreactors, tanks in Fremont, CA at Apex Life Sciences

Date Posted: 6/6/2018

Job Snapshot

Job Description


Responsibilities:

  • Responsible for ensuring cleaning processes are validated to required standards.
  • Manage all moderate troubleshooting efforts for protocol discrepancies.
  • Responsible for developing moderate complex protocols using a risk-based approach that meets current regulatory requirements and industry practices.
  • Presents the validation approach and protocol results to peers, management as required.
  • Support cleaning executions by providing execution oversight, conducting training, issuing execution sheets, LIMS labels, review executed documents for accuracy, compilation of execution binder and support report generation.
  • Reviews and interprets data for accuracy for completed validations/re-validations, and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
  • Provides technical input to validation deviations; provides assessments for change requests and identifies qualification requirements to ensure the validated state is maintained.
  • Reviews controlled documents relating to cleaning validations.


Skills

  • Bachelor's Degree in Life Sciences or related desired
  • Experience in cleaning validation is preferred.
  • 4+ years of pharmaceutical Quality experience, knowledge of Validation Lifecycle Approach.
  • Excellent technical writing and verbal communication skills
  • Ability to read/interpret P&ID documents
  • Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
  • Demonstrated ability to manage multiple activities while maintaining a high level of organization.
  • Must have a strong understanding of validation principles.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
  • Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
  • Ability to interpret and relate Validation standards for implementation and review to functional areas.
  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
  • Demonstrate solid understanding and application of small-scale versus production-scale process validation.
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
  • Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
  • Ability to interpret and relate Validation standards for implementation and review to functional areas.
  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.

***For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Cleaning Validation Specialist' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.