Validation Professional

2 weeks ago

Carlow, Ireland beBeePharmaceutical Full time €60,000 - €80,000

We're recruiting for an exciting opportunity in the pharmaceutical industry.

About the Role
  • Develop and execute cleaning cycle development and process qualification of equipment to ensure compliance with regulatory guidelines.
  • Write and adhere to validation strategies, coordinating with vendors, writing protocols independently, submitting samples, analyzing test results, and preparing technical reports.
  • Manage business activities such as equipment periodic reviews, cleaning periodic reviews, CAPAs, deviations, change control, risk assessments, and document approval.
  • Provide support during commissioning phase by reviewing and approving documents, ensuring documentation meets industry standards.
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
  • Conduct technical report writing, statistical analysis of data, and ensure adherence to regulatory guidelines.
  • Represent the IPT on cross-functional project teams and provide technical input and support.
  • Present as a subject matter expert on relevant topics during regulatory inspections and maintain highest standards for Compliance (Quality and Safety).
  • Ensure compliance with site EHS policy, cGMP, and other business regulations, supporting Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
  • Adhere to the Manufacturing Division Quality Management System (QMS) requirements, including ownership, to ensure highest Quality, Compliance, and Safety standards.
Required Skills and Qualifications
  • Minimum 3 years of experience as a validation specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or equivalent in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations, manufacturing, or Process Engineering.
  • Familiarity with GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.

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