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Equipment Validation Engineer Location: US-NY-Albany Email this job to a friend
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Role: Equipment Validation Engineer Location: Albany, NY Duration: 24 months on W2 Required Skills: - Provide validation oversight of Site Acceptance Testing ("SAT") and commissioning activities.
- Prepare IQ, OQ and PQ documentation, as necessary, including Deviations, Summary Reports and Trace Matrices.
- Execute validation protocols following Good Documentation Practices (GDP).
- Deviation investigation and resolution/closure.
- Oversee Vendor SAT execution to verify GDP is being complied with
- Review life cycle documentation for completeness and pertinent details
- Knowledge, experience and practice of aseptic filling and packaging
- Experience in Document Preparation and approval for Manufacturing equipment
- Experience of field execution shall include equipment as listed on in section 3 of this document.
- Experience working hands-on with these systems.
- Good knowledge of the inter-dependencies of utility systems and dependencies of process systems on utilities.
- Experience with operating or interfacing with control systems such as Allen Bradley PLCs.
- Experience in a start-up environment, working to a Project schedule
- Experience in maintaining daily and weekly progress trackers/reports.
- Sound knowledge of Industry Regulations, Guidelines and practices as they pertain to the Biopharma DS/DP industries.
- Strong knowledge and experience with ISO and EU standards
- Understanding and practical application of EU Annex 1
- Filling Equipment manufacturer is SKAN, Bausch + Strobel. The individual should have Isolator Qualification experience and knowledge on how a filling line operates
Intellectt INC
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