This position is for a Validation Contractor for the Validation Engineering group . The candidate will be responsible for supporting validation activities. This includes supporting Periodic Reviews of validated equipment in SSFP, which entails review of change records for validation impact, through the TrackWise system. The Periodic Review will also include review of monitoring data trends and validation lifecycle documents. These reviews will be compiled in a Periodic Review summary report.
The contractor will support revalidation execution on equipment to ensure the equipment has been operating in a validated state, Cleaning Validation activities, New Product Introduction (NPI), and qualification of changes to GMP equipment. Activities may include but are not limited to protocol generation, execution of protocols, swab and rinse water sampling, data analysis, reviewing worksheets, obtaining batch records and QC results, and summary report authoring.
The contractor will be expected to work effectively with customers (System Owner and Technical SME and Quality) to complete these validation activities. Contractor must follow all safe work practices including use of appropriate Personal Protective Equipment and ensure training is up to date.
Standard work hours are Monday through Friday day shift however weekend work or off hour work may be required. Working remotely is not permitted for this position.
The candidate must be highly self-motivated, have excellent organization and communication skills, and be willing and able to work independently or as part of a multi-disciplinary team. Attention to detail, critical thinking, and ability to comprehend complex systems are essential characteristics of a successful candidate. Experience in a GMP regulated environment, including GDP, and use quality systems and processes such as change control and discrepancy / deviation processes is desirable, but not required.
A B.S. in Chemical, Biochemical or Mechanical Engineering or Science discipline with 0-3 years of relevant experience