[ref. m73298900] Equipment Validation Engineer

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