Process Validation Specialist

Fremont, CA 94555

Posted: 10/11/2018 Employment Type: Contract Industry: Clinical & Scientific Job Number: 14018

Bayside Solutions is seeking a  Process Validation Specialist  to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Process Validation Specialist?

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Responsible for  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. 
  • 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 on direct impact systems; and identifies qualification requirements to ensure the validated state is maintained.
  • Reviews controlled documents relating to processes, cleaning, equipment, and computer systems validations.

 

Required Qualifications:
  • Bachelor' s Degree.  6 years of pharmaceutical Quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
  • Masters Degree with 4 years of pharmaceutical quality experience, knowledge of Validation Lifecycle Approach (e.g. ASTM E2500, GAMP).
  • Process validation background/experience validating commercial drug substance/drug product. 
  • Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes.
  • Experience with planning and generating validation protocols and reports
  • Statistical analysis of manufacturing and QC data for PPQ reports. 
  • Investigate root cause and implement corrective actions for validation discrepancies
  • Excellent technical writing and verbal communication skills
  • Must have a strong understanding of validation principles.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company. 
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
  • Ability to read/interpret process development and characterization documents
  • Ability to interpret and relate Validation standards for implementation and review to functional areas.
  • Ability to work as part of a high performing team and collaborate effectively with staff at all levels.
  • 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.
  • Demonstrated ability to manage multiple activities while maintaining a high level of organization.
  • Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Demonstrate solid understanding and application of small-scale versus production-scale process validation.

Erik Cordova

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