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    Sr. Validation Engineer - Los Angeles, United States - BioPhase Solutions

    BioPhase Solutions
    BioPhase Solutions Los Angeles, United States

    2 weeks ago

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    Description

    Job Description

    Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a contract Sr. Validation Engineer to work for a leading Greater Los Angeles area biotechnology company.
    Pay Rate: $60-70/hour depending on experience
    Summary:We are looking for an exceptional individual to join as a temporary Senior Validation Engineer. This position will report directly to the Manager, Quality Engineering. This is an onsite role with an approximate duration of four months.
    Responsibilities:
    • Support the company's Quality Engineering group with documentation and validation needs.
    • 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.
    Experience:
    • 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 and visit our website at for additional job opportunities
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