Validation Field Specialist

Found in: Appcast US C2 - 1 week ago


Horsham, United States Planet Pharma Full time

MUST BE OPEN TO 90% TRAVEL


What You Will Do:

  • Assisting in providing information to sales staff regarding site specific equipment and documentation requirements for effective decontamination of target areas and their validation.
  • Working with client representatives to ensure they obtain the correct documentation to achieve goals and certifications required by site.
  • Leading or assisting in the development of job-specific, on-site protocols for the validation work to be carried out on client locations.
  • Collecting site specific information in preparation of equipment installation and commissioning.
  • Maintaining a strong working knowledge of cGMP practices and provide consultation to Bioquell staff on the subject
  • Traveling extensively (at least 80% of the time) to domestic and international client sites to execute developed protocols including but not limited to:
  • New equipment installation, setup, commissioning
  • Equipment integration testing
  • Operator training
  • Calibration on new equipment
  • Troubleshooting new installations on site
  • Cycle development services on clients sites for cGMP and non-cGMP facilities
  • Equipment performance qualifications
  • Reacting to and remedying emergency client requests for information and services in a professional and flexible manner.
  • Providing upkeep to validation equipment to ensure it is in safe working condition.
  • Participating in departmental cross-training with service and RBDS responsibilities to assist in these roles when necessary.
  • Writing and executing material testing protocols as needed for clients requesting this service.
  • Handling micro-organisms as an integral part of verification/validation of the decontamination cycle development process.
  • Collecting and recording site specific data.
  • Generating, reviewing and distributing required site specific reports.
  • Following company policies, procedures and business ethics codes.??

Position Details:

  • Work Schedule: Monday to Friday, 40 hours a week, including occasional weekend work
  • Weekend working may be required
  • Security clearance may be required for certain clients

Minimum Qualifications:

  • Strong background in science, engineering, math or other technical discipline
  • Full understanding of scientific process with strong analytical abilities
  • Outstanding technical aptitude for mechanical and electrical assemblies
  • Excellent troubleshooting abilities
  • Working knowledge of cGMP practices
  • Professional, respectful supervisory behaviors and approach
  • Willingness to travel (minimum of 80% of time, with possibility of travel abroad)
  • Responsible, reliable, quality conscious attitude and commitment to job requirements and performance

Physical Demands:

  • Ability to complete pre-employment assessments including a physical, lift and/or carry 50 pounds and drug screen
  • Personal protection: Personal protection equipment (PPE) may be worn on customer sites

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