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Bio Process Equipment Validator

2 months ago

Severn, Maryland, United States Catalent Full time

Job Summary:

Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Equipment Validation Specialist to join our team in a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service.

Key Responsibilities:

  • Develop and implement operational protocols, qualification IQ, OQ, PQ protocols, and SOPs for various equipment/systems/processes in the facility.
  • Project based work will be in 3 main areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS).
  • Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems.
  • Provide hands-on support to the manufacturing areas as required to assist in problem-solving and long-term changes that provide product/process improvements in relation to equipment failures.
  • Support the validation program for process qualification, aseptic processing, and cleaning verification activities.
  • Provide SME level support to the manufacturing areas as required to assist in problem-solving and long-term changes that provide product/process improvements in relation to process failures.

Requirements:

  • Bachelor or Master's degree in Life Science or Engineering field with preference to Chemical/Biochemical Engineering.
  • 2+ years of validation experience in a GMP environment, supporting equipment qualification and facilities commissioning activities.
  • Experience with qualifying QC Analytical equipment and Facilities/Utilities is desirable.
  • Working knowledge of Kaye datalogging equipment (Validator, AVS, ValProbe).

Why Catalent:

  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Positive working environment focusing on continually improving processes to remain innovative.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 Hours + 8 paid holidays.
  • Several Employee Resource Groups focusing on D&I.
  • Dynamic, fast-paced work environment.
  • Community engagement and green initiatives.
  • Generous 401K match.
  • Company match on donations to organizations.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement – Let us help you finish your degree or start a new degree.
  • WellHub program to promote overall physical wellness.
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.