Cleaning Validation Specialist II

4 weeks ago

Columbus, Ohio, United States Hikma Pharmaceuticals PLC Full time
About Us

Hikma Pharmaceuticals USA Inc. is a leading developer, manufacturer, and supplier of essential medicines. Our mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world.

Job Title: Specialist II, Cleaning ValidationJob Summary

We are seeking a talented and motivated Specialist II, Cleaning Validation to join our team. In this role, you will be responsible for supporting site cleaning and cleaning validation processes from product development through product lifecycle.

Key Responsibilities
  • Develop procedures for cleaning processes utilized in operations, including cleaning, inspection, and cleaning verification work instructions.
  • Optimize and improve the consistency and effectiveness of cleaning processes, developing a validation deliverable that complies with regulatory guidelines and business requirements.
  • Support employee training to ensure compliance to procedure and process effectiveness.
  • Conduct periodic reviews of the compliance of cleaning processes and to ensure the effectiveness of the cleaning validation program.
  • Coordinate data collection, organization, and archival for cleaning validation program, including testing for new and existing products, changes to cleaning processes or equipment, and new equipment.
  • Coordinate sampling logistics, including batch identification and tracking.
  • Maintain the Master Data and execute product, equipment, and system evaluations using a risk-based approach, including performing required calculations.
  • Design and author technical protocols and reports in alignment with the philosophy defined by the Cleaning Validation engineering team.
  • Compile cleaning verification and validation data, investigations, and change control information for technical reports related to the cleaning program.
  • Track equipment and product qualification status.
  • Participate in the development of appropriate testing strategies, including swabbing location.
  • Support the optimization of processes, including manual and automated cleaning processes.
  • Support the development of cleaning activities to ensure that the system's validation state is maintained.
  • Identify testing approach and cleaning swab sample locations on new equipment and/or for new products in alignment with the philosophy defined by the Cleaning Validation engineering team.
  • Participate in the creation of policies, procedures, guidelines, and templates in the area of validation.
Qualifications
  • Bachelor's degree in engineering or related scientific discipline required with a minimum of four (4) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
  • Require 1-3 years specific cleaning validation experience in a pharmaceutical environment.
  • Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.
  • In lieu of a degree, require a minimum of eight (8) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
  • Require 3 years specific cleaning validation experience in a pharmaceutical environment.
  • Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.
  • Experience with the authoring and execution of Quality documentation, including validation documentation, technical protocols, procedures, and/or technical reports.
What We Offer
  • Annual performance bonus, commission, and share potential.
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute.
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries.
  • 3 personal days (prorated based on hire date).
  • 11 company paid holidays.
  • Comprehensive benefits, including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
  • Employee discount program.
  • Wellbeing rewards program.
  • Safety and Quality is a top organizational priority.
  • Career advancement and growth opportunities.
  • Tuition reimbursement.
  • Paid maternity and parental leave.

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