Validation Specialist

hace 1 semana


Juncos, Puerto Rico Pharmalex A tiempo completo
About the Role

We are seeking a highly skilled Validation Specialist - Cleaning Process Development to join our team at Pharmalex in Juncos, Puerto Rico.

Job Summary

This role is responsible for developing and executing cleaning validation programs for various equipment types, including process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities. The ideal candidate will have hands-on experience supporting IQ/OQ (IOQ) equipment qualification related to various cleaning processes and activities.

Key Responsibilities:
  • Develop and execute cleaning revalidation programs
  • Create cleaning cycle development strategies for various equipment types
  • Write validation protocols and reports in support of the site's cleaning validation program
  • Investigate and troubleshoot problems during cleaning operations
  • Plan and execute onsite cleaning validation programs compliant with regulatory requirements
Requirements

To be successful in this role, you should possess a Bachelor's degree in Engineering or a Scientific field and have at least 5+ years of experience in a regulated manufacturing industry. Additionally, you should have demonstrated knowledge of cGMP/FDA regulations, strong communication skills, and the ability to organize and manage multiple tasks in a fast-paced environment.

What We Offer

We offer a competitive salary range of $80,000 - $110,000 per annum, depending on qualifications and experience. Our benefits package includes professional development opportunities, training, and a stimulating work environment that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.



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