Validation Engineer

Validation Engineer – Florida
 
PharmEng Technology is currently seeking a Validation Engineer for a project in Florida, USA. The position is available immediately conditional of a successful interview
 
Job Description:
  • Validate Lab Equipment such as FTIR, UV Vis Spectrophotometer, Filter Integrity Tester, Mixer/ Shaker, HPLC, GC
  • Perform Thermal Validation such as Fridge, Freezer, incubator, water bath, tanks using kaye valprobe and/or ellab Tracksense Pro
  • Validate Manufacturing Equipment such as Tanks (mixing, viral inactivation, jacketed), centrifuges, PAS (Rockwell), BMS (Siemens), Filters (Ultra filtration), HVAC, pumps
  • Perform Process Development and Process Validation studies for VI tank mixing study for detergent uniformity, UF-skid operating pressure determination/optimization to reduce stress on IgG protein
  • Investigate and write comments / deviation reports following the established SOP. Route and follow up the deviation reports through the evaluation, review and approval
  • Technical Support: Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform technical reviews of validation deliverables.
  • Develop technical support manuals and provide technical input to address system troubleshooting and administration post system release.
  • Be able to quickly learn and configure new applications, system architecture, and instrumentation with or without vendor assistance and training.
  • Create Technical Support Manuals for all new GMP systems.
  • Perform routine utilities system audits and collect performance data to optimize equipment operation and increase reliability. Participate in all related internal and external audits as needed.
  • Will work closely with team members from HSE, Quality, and Manufacturing to address operational and compliance issues.
Job Requirements:
  • Must be familiar with different modes of communication between computer and instrumentation it interacts with (TCP/IP, local networks, static vs. dynamic, RS232 configuration). Experience with relational databases a plus.
  • BS/MS in Engineering or related Science discipline with 5+ years of relevant experience 
  • Experience with validation, and with knowledge of production.
  • knowledge of mixing, filling, filtration and sterilization process as it relates to FDA manufacturing
  • Knowledge of USP, EP, JP and FDA requirements
  • This individual should be a self-starter with strong interpersonal, organizational and technical skills, with the capability to work both independently and in a team environment at all levels of the organization. Strong analytical and communications skills are critical.
  •  Basic understanding of validated and commissioned utilities systems, process gas distribution, water treatment, and process control philosophies.
  • Proven track-record of leading teams and project management experience is highly desired
 

Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted
 
 
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