CQV Engineer - North Brabant - Blackfield Associates

    Blackfield Associates
    Blackfield Associates North Brabant

    5 dagen geleden

    Beschrijving
    • Key Responsibilities:


    •Documentation:

    o Develop and Update several Validation documents.

    E.g. System Level Criticality Assessments,

    Validation, Commissioning, Qualification plans,

    Risk assessments,

    Test Protocols,

    Requirement traceability matrixes

    Commissioning, Qualification and Validation summary reports

    • Basic Qualifications & Experience:


    • Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g. Systech, Cognex)


    • At least 3 years' experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries.


    • Experienced in Computerized Systems Validation


    • Hands on commissioning and qualification experience within Secondary Packaging Operations.


    • Good understanding of the role of a single document within the bigger picture.


    • Internal and /or external reporting relationships.

    • Preferred Qualifications & Experience:


    • Ability to work independently and remotely with minimum direct supervision


    • Good English Technical Writing

    • Excellent communication skills


    • Customer relationship management skills


    • Critical thinking skills


    • Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation.


    • Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.


    • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise.

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