Senior Validation Engineer

2 weeks ago

Los Angeles, California, United States BioPhase Solutions Full time
Job Title: Senior Validation Engineer

BioPhase Solutions is seeking a highly skilled Senior Validation Engineer to join our team. As a Senior Validation Engineer, you will be responsible for supporting the company's Quality Engineering group with documentation and validation needs.

Responsibilities:
  • Support validation activities and execution for expansion of new manufacturing workstations.
  • Aid in department and document deviations.
  • Perform validation activities as needed.
  • Review and approval of validation documents.
  • Provide knowledge to vendors and other contractors validation principles and correction plans/actions, as needed.
  • Update Draft SOPs to the company's templates.
  • With guidance from departmental subject matter expert / SOP owners, draft standard operation procedures and associated forms into required company SOP/Form formats.
  • Utilize specified company document review / approval process to submit draft SOPs, Forms, and Protocols for approval.
  • Assist in scheduling meetings within the organization and put together meeting minutes/notes, as needed.
  • Establish schedules with vendors and internal departments as needed.
  • Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
  • Provide weekly and monthly progress updates to project team.
  • Attending Project meetings and relay project status as required.
  • Writing / reviewing equipment and computer system documentation – specifications, C&Q test protocols, final reports, and routing for approval as required.
  • Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
  • Escalate issues to leadership as needed.
  • May perform project management and other tasks, as needed.
Requirements:
  • Master's Degree and 2+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR
  • Bachelor's Degree and 4+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR
  • High School Degree and 8+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations
  • Knowledgeable in various areas of equipment and computerized systems with strong understanding of life cycle approach and change control management.
  • Self-motivated / disciplined.
  • Strong interpersonal communications skills with excellent technical writing abilities.
  • Demonstrated application of engineering principles on projects.
  • Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
  • Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
  • Able to work collaboratively and cross-functionally with other departments and vendors.
  • Ensure a safe work environment is maintained through adherence to safety guidelines and policies set forth by the company

Please send resumes to BioPhase Solutions for consideration.

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